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Chemotherapy induced peripheral neuropathy Pipeline Insight to See Strong Expansion Through 2027 Covid-19 Analysis The Courier – The Courier

May 14th, 2021 1:54 am

Chemotherapy induced peripheral neuropathy Pipeline Insight Market Report defines the business objective to help business owners to avoid contradictory expectations. It provides you customer data along with their demands hence you can accordingly plan for the launching of the product in the market. It presents all the data about whole market scenario. With the help of prominent data provided in the Chemotherapy induced peripheral neuropathy Pipeline Insight Market Report, organizations come to know about customers completely and can achieve their goal of selling products in huge quantity and getting huge profits too. Clearly setting the business goal at the beginning will surely help to avoid getting difficulties and set the business easily.

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https://www.researchforetell.com/reports/64859/chemotherapy-induced-peripheral-neuropathy-pipeline-insight-2021/request

Chemotherapy induced peripheral neuropathy (CIPN): Therapeutic Assessment

This segment of the report provides insights about the different Chemotherapy induced peripheral neuropathy (CIPN) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Chemotherapy induced peripheral neuropathy (CIPN)

There are approx. 15+ key companies which are developing the therapies for Chemotherapy induced peripheral neuropathy (CIPN). The companies which have their Chemotherapy induced peripheral neuropathy (CIPN) drug candidates in the most advanced stage, i.e. phase II include, MediciNova.

Phases

DelveInsight s report covers around 15+ products under different phases of clinical development like

Late stage products (Phase III)

Mid-stage products (Phase II)

Early-stage product (Phase I) along with the details of

Pre-clinical and Discovery stage candidates

Discontinued & Inactive candidates

Route of Administration

Chemotherapy induced peripheral neuropathy (CIPN) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

Oral

Parenteral

intravitreal

Subretinal

Topical.

Molecule Type

Products have been categorized under various Molecule types such as

Monoclonal Antibody

Peptides

Polymer

Small molecule

Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chemotherapy induced peripheral neuropathy (CIPN): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chemotherapy induced peripheral neuropathy (CIPN) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chemotherapy induced peripheral neuropathy (CIPN) drugs.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Chemotherapy induced peripheral neuropathy (CIPN) R&D. The therapies under development are focused on novel approaches to treat/improve Chemotherapy induced peripheral neuropathy (CIPN).

In December 2019, Solasia Pharma entered into an exclusive license agreement with Maruho for commercialization of Solasia s product SP-04 (PledOx , hereinafter product ), a therapeutic agent for chemotherapy induced peripheral neuropathy (currently undergoing Phase III clinical trials) in Japan.

Chemotherapy induced peripheral neuropathy (CIPN) Report Insights

Chemotherapy induced peripheral neuropathy (CIPN) Pipeline Analysis

Therapeutic Assessment

Unmet Needs

Impact of Drugs

Chemotherapy induced peripheral neuropathy (CIPN) Report Assessment

Pipeline Product Profiles

Therapeutic Assessment

Pipeline Assessment

Inactive drugs assessment

Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

How many companies are developing Chemotherapy induced peripheral neuropathy (CIPN) drugs

How many Chemotherapy induced peripheral neuropathy (CIPN) drugs are developed by each company

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chemotherapy induced peripheral neuropathy (CIPN)

What are the key collaborations (Industry Industry, Industry Academia), Mergers and acquisitions, licensing activities related to the Chemotherapy induced peripheral neuropathy (CIPN) therapeutics

What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies

What are the clinical studies going on for Chemotherapy induced peripheral neuropathy (CIPN) and their status

What are the key designations that have been granted to the emerging drugs

Key Players

NeuroBo Pharmaceuticals

Aptinyx

Midatech Pharma

MediciNova

Sonnet BioTherapeutics

Toray Industries

EA Pharma

AnnJi

Asahi Kasei Pharma

PledPharma

Key Products

NB-01

NYX-2925

KRN5500

MN-166 (ibudilast)

SON-080

TRK-750

EA4017

AJ302

SP-04

Thrombomodulin alfa

Calmangafodipir

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Key Features of the Report:

Complete report is available at

https://www.researchforetell.com/reports/64859/chemotherapy-induced-peripheral-neuropathy-pipeline-insight-2021

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Research Foretell is an information service company that provides market research, custom, and consulting services. Decision-making is complicated and we help you to solve your biggest puzzle, by identifying, analyzing, and monitoring the recent developing technologies and markets. Research Foretell is always forefront on classifying new opportunity in the market; with us you always have the first mover advantage.

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Chemotherapy induced peripheral neuropathy Pipeline Insight to See Strong Expansion Through 2027 Covid-19 Analysis The Courier - The Courier

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Diabetic Retinopathy Market Size Growth Expects Significant Thrust at a CAGR of 3% During the Study Period, 2018-30 in the 7MM | DelveInsight -…

May 14th, 2021 1:54 am

LAS VEGAS, May 12, 2021 /PRNewswire/ -- DelveInsight's Diabetic Retinopathy MarketInsightsreport offers detailed information on current treatment practices, emerging drugs, Diabetic Retinopathy market share of the individual therapies, current and forecasted Diabetic Retinopathy market size from 2018 to 2030 segmented into 7MM (the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan).

Some of the key takeaways from the Diabetic Retinopathy MarketInsights:

Download report to know which drug is going to capture the maximum market share @ Diabetic Retinopathy Market Analysis and Forecast

Diabetic Retinopathy: Disease Overview

Diabetic Retinopathy is a significant complication of diabetes mellitus, which is a leading cause of visual loss in working-age populations. With an increasing prevalence of diabetes, it appears that the prevalence of Diabetic Retinopathy is also on the rise. Type 2 diabetes, which is becoming more common, leads to over 60% of patients diagnosing with Diabetic Retinopathy within the first 20 years of onset.

Furthermore, Age is a noteworthy risk factor for Diabetic Retinopathy prevalence as the chances increase with the age.

Diabetic Retinopathy Epidemiology Segmentation

Diabetic RetinopathyMarket and Epidemiology Report offers historical as well as forecasted epidemiological analysis during the study period 2018-30 in the 7MM segmented into:

The report proffers a holistic view of the present Diabetic Retinopathy treatment practice/algorithm, market drivers, market barriers, and unmet medical needs that help clients curate the best of the opportunities and assess the market's hidden potential, and plans strategically to handle market risks.

For a comprehensive analysis, visit Diabetic Retinopathy Epidemiological Analysis and Changing Trends

Diabetic Retinopathy Therapy Market

The present scenario in the Diabetic Retinopathy therapeutic landscape appears quite confined, limited to laser treatment, eye injections, and anti-VEGF drugs, which are the preferred first line of therapy. The treatments for DR relies heavily on the presence of macular edema.

Available anti-VEGF drugs include aflibercept (Eylea from Regeneron and Bayer), ranibizumab (Lucentis from Genentech and Novartis), and bevacizumab (Avastin from Genentech) that are presently enjoying the monopoly in the Diabetic Retinopathy market.

However, there exist several gaps in the Diabetic Retinopathy therapeutic market in the form of an absence of biomarkers, a lack of technologies that are potential enough to predict the disease course in patients, and novel pathways to offer novel treatments.

Reach out to us @ Diabetic Retinopathy Marketed Therapiesfor more information on available treatment regimens

Diabetic Retinopathy Market

The Diabetic Retinopathy market encompasses several novel pipeline therapies with better efficiency and tolerability than conventional and available therapies. Key companies such as Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Kubota Vision, Allegro Ophthalmics, and several others are developing new drugs that project a promising picture of the Diabetic Retinopathy market landscape in the coming decade.

The market has limited options to offer, and a lack of gene therapy, personalized treatment approaches offer pharma companies a latitude to explore and penetrate with novel gene therapies, biosimilars into the market.

This does not only promise one-time treatment but also facilitates the usage of lower doses ascribed to favorable anatomy of the eye owing to its size. Moreover, an increasing patient pool also gives pharma companies room for making cost-effective drugs without compromising with gains. Different possible pathways have been extensively studied, which could be responsible for the disease. Therefore, a better understanding has been obtained through years of thorough research and development. The emergence of personalized medications is expected to further drive the growth of the DR market share.

Diabetic Retinopathy Pipeline Therapies and Key Companies

Brolucizumabt: Novartis PharmaceuticalsFaricimab: RocheADVM-022: Adverum BiotechnologiesEmixustat Hydrochloride: Kubota VisionKVD001: KalVista Pharmaceuticals

Get a detailed analysis of Diabetic Retinopathy Emerging Drug Pipeline and Key Companies

Scope of the Report

Coverage: 7MM (the US, EU5, and Japan)Study Period: 2018-30Key Companies: Novartis, Roche, Adverum Biotechnologies, Kubota Vision, Kodiak Sciences andAllegro Ophthalmics.Key Diabetic Retinopathy Pipeline Therapies:Brolucizumab, Faricimab, ADVM-022, Emixustat Hydrochloride, KVD001, KSI-301 and Risuteganib.Diabetic Retinopathy Market Segmentation:By Geography, By Diabetic Retinopathy TherapiesAnalysis: Comparative and conjoint analysis of Diabetic Retinopathy emerging therapiesTools used: SWOT analysis, Conjoint Analysis, Porter's Five Forces, PESTLE analysis, BCG Matrix analysis methods.Case StudiesKOL's ViewsAnalyst's Views

Drop by to learn more about the future market trends@ Diabetic Retinopathy Market Landscape and Forecast

Table of Contents

1

Key Insights

2

Diabetic Retinopathy Market Report Introduction

3

Diabetic Retinopathy Market Overview at a Glance

4

Executive Summary of Diabetic Retinopathy

5

Disease Background and Overview

6

Organizations in the Diabetic Retinopathy Market

7

Diabetic Retinopathy Epidemiology and Patient Population

8

Diabetic Retinopathy Treatment

9

Diabetic Retinopathy Marketed Therapies

10

Diabetic Retinopathy Emerging Therapies

11

Diabetic Retinopathy: 7 Major Market Analysis

10

The United States Diabetic Retinopathy Market Analysis

12

EU5 Diabetic Retinopathy Market Analysis

13

Japan Diabetic Retinopathy Market Analysis

14

Diabetic Retinopathy Market Unmet Needs

15

Case Reports

16

Diabetic Retinopathy Market Drivers

17

Diabetic Retinopathy Market Barriers

18

SWOT Analysis

19

KOL Reviews

20

Appendix

21

DelveInsight Capabilities

21

Disclaimer

22

About DelveInsight

Take a tour of the report @ Diabetic Retinopathy Market Forecast and Trends

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Get in touch with our Business executive forRich and Deep Market Assessment and Consulting Solutions

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

For more insights, visit Pharma, Healthcare and Biotech News

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Diabetic Retinopathy Market Size Growth Expects Significant Thrust at a CAGR of 3% During the Study Period, 2018-30 in the 7MM | DelveInsight -...

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GenSight Biologics Provides 2021 Operations Update in the Context of COVID-19 – Business Wire

May 14th, 2021 1:54 am

PARIS--(BUSINESS WIRE)--Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today provides an update on the impact of COVID-19 on its operations in 2021.

It has been slightly over a year since we had to adjust our operations to the COVID-19 situation and provided you with an update on our activities. Although conditions have improved in many regions, the burden of the COVID-19 crisis continues to impact the medical and regulatory ecosystems. GenSight is preparing for the commercialization of LUMEVOQ first in Europe in 2022, then in North America a year later, despite the US Defense Production Act introducing a slight delay in manufacturing our validation batches, said Bernard Gilly, Co-founder and Chief Executive Officer of GenSight Biologics. Our team will be ready in due time to deliver LUMEVOQ to patients affected with this highly debilitating disease and continue to work tirelessly to develop alternative strategies to minimize the impact of COVID-19 on our operations.

LUMEVOQ Commercial Launch in Europe Still Expected in H1 2022

The REVERSE and RESCUE Phase III trials of LUMEVOQ (GS010) for the treatment of Leber Hereditary Optic Neuropathy (LHON) are completed, and patients have been transferred to long-term follow-up, the RESTORE study, for an additional three-year period. The sustained efficacy of LUMEVOQ three years after injection was previously reported. Patients are now followed-up annually, and given the follow-up nature of these visits and the stability of patients with no safety concern, delaying some of these visits has been an acceptable precautionary measure, which should have no impact on the conduct of the trial, and will be properly documented and reported to regulators.

The strategic manufacturing partner (CDMO) for LUMEVOQ, ThermoFischer Scientific (TFS) in Boston, USA, is maintaining its operations and is due to manufacture three validation batches to support the MAA filing with the European Medicines Agency (EMA) in Europe. TFS informed the Company that, as a consequence of the US Defense Production Act (DPA), American suppliers have had to redirect certain consumables towards the manufacture of COVID vaccines in the US. It is our understanding that this is an Industry issue impacting many manufacturers, biotech and pharmaceutical companies in particular. This has resulted in extended timelines for the availability of some items required for manufacturing LUMEVOQ. Accordingly, the Company anticipated delays in providing data from the planned validation batches to the EMA and, after discussions with the European Agency, agreed upon an extended clock-stop period. Responses to the Agency D120 questions are therefore now due by January 2022 instead of the previously anticipated August 2021. Based on this new timeline the Company now expects EMA approval for LUMEVOQ to shift from Q4 2021 to H1 2022. The revised timeline will be confirmed as soon as there is greater clarity from TFS on material availability. The timing for commercialization remains unchanged and the Company will continue to build the European commercial platform during 2021 to prepare the commercial launch of LUMEVOQ in Europe, still expected in H1 2022.

LUMEVOQ Regulatory Pathway in the US: REFLECT Phase III read-out in June 2021; BLA Submission Now Expected Q2 2022

The REFLECT Phase III trial of LUMEVOQ is fully recruited with a primary endpoint at 78 weeks. Although some on-site visits had to be postponed due to COVID-19 travel restrictions, the Company closely partnered with clinical sites and properly documented and reported delays to regulators, as well as pre-specified them in the Statistical Analysis Plan (SAP), in agreement with biostatisticians, before database lock. Consequently, GenSight Biologics was able to collect data from 95 out of 98 patients with no consequence on the primary endpoint, other than a delay in the 78-week read out from Q1 initially to June 2021. The Company expects to meet with the U.S. Food and Drug Administration (FDA) for a pre-BLA meeting in Q3 2021. Due to the impact of the US DPA on the manufacturing of LUMEVOQs validation batches, the regulatory submission target in the US is now Q2 2022.

PIONEER Phase I/II Clinical Trial of GS030 in Retinitis Pigmentosa (RP)

In order to protect patients, the Company and investigators together decided to delay recruiting new patients into the 3rd cohort of the PIONEER Phase I/II clinical trial of GS030 until the COVID-19 situation had improved, as RP is a chronic disease and does not require urgent treatment. The use of corticosteroids pre- and post-gene therapy injection, performed as part of the protocol to minimize inflammatory response, was deemed by GenSight and investigators to expose patients to a higher risk of COVID-19 infection. In the interim, the six patients in the first two cohorts were remotely monitored for safety aspects by investigators. Consequently, recruitment took longer than originally planned.

PIONEER, combining gene therapy and optogenetics for the treatment of RP, has now fully completed recruitment of the 3rd cohort. The Data Safety Monitoring Board (DSMB) is expected to make a recommendation on the optimal dose to use in the extension cohort in the coming weeks. GenSight Biologics expects to complete the recruitment of the extension cohort by the end of 2021. In the meantime, the Company expects to report early findings shortly in Q2 2021 and more preliminary results later in the second half of the year.

LUMEVOQ Temporary Authorization for Use, Compassionate Use and Early Access Programs

Additional patients were treated with LUMEVOQ in France in Q1 2021 under a nominative Temporary Authorization for Use (ATU) granted by the French National Drug Safety Agency (Agence Nationale de Scurit du Mdicament or ANSM). Additional ATUs have been requested by the CHNO of the Quinze-Vingts in Paris.

GenSight is committed to providing the drug, subject to available stock. For now, the Company does not foresee any shortage due to the impact of the DPA on TFS in the US and is closely monitoring the situation. Bilateral injections are priced at 700,000 per patient and are expected to generate revenues prior to regulatory approval and official reimbursement in France. In addition, the Company has submitted to the French ANSM an application for a cohort ATU to further facilitate access to LUMEVOQ for patients in France. The application is under review and patients can benefit from nominative ATUs in the meantime.

Compassionate use in Italy was granted with some patients already treated in Q1 2021. A compassionate use program in Germany is under review by competent authorities. Patients have also been treated in the United States under an Expanded Access Program granted by the FDA. For all these programs, LUMEVOQ is provided free of charge to requesting physicians.

GenSight continues to implement measures to protect its staff against COVID-19 by putting in place telecommuting for all employees. These measures have not affected activities carried out at its Paris headquarters.

The Company is financed until at least the end of Q2 2023 and is able to face any evolution of the COVID-19 situation with as much flexibility and foresight as required.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. Using its gene therapy-based approach, GenSight Biologics product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Developed as a treatment for Leber Hereditary Optic Neuropathy (LHON), GenSight Biologics lead product candidate, LUMEVOQ (GS010; lenadogene nolparvovec), is currently in the review phase of its registration process in Europe, and in Phase III to move forward to a BLA filing in the U.S.

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GenSight Biologics Provides 2021 Operations Update in the Context of COVID-19 - Business Wire

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Cohort study protocol to characterize the incidence and severity of neuropathic pain in patients with severe acute respiratory syndrome coronavirus 2…

May 14th, 2021 1:54 am

This article was originally published here

Pain Rep. 2021 Apr 20;6(1):e925. doi: 10.1097/PR9.0000000000000925. eCollection 2021.

ABSTRACT

INTRODUCTION AND OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic has resulted in patients experiencing symptoms that include neurological dysfunction. As many viral infections are associated with neuropathy, the aim of the study is to characterize the incidence and severity of neuropathic pain in patients with COVID-19.

METHODS: A cohort study will be conducted in adult (18 years) patients who were tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Washington University/Barnes-Jewish Hospital. Participants who are deceased, with incomplete test results, or who cannot be contacted will be excluded. Approximately 1320 participants will be recruited in a 1:2 ratio of those with a positive-to-negative SARS-CoV-2 test result. Each participant will be invited to complete a survey to assess their symptoms related to neuropathy, 30 to 90 days after their initial SARS-CoV-2 test. Survey responses, demographics, and clinical data from the electronic health record will be used for analysis. The primary outcome is the incidence of new symptoms of neuropathic pain. The self-reported DN4 and Neuropathic Pain Symptom Inventory questionnaires (Appendix 1, http://links.lww.com/PR9/A103) will be used for neuropathic pain screening and severity assessment, respectively. Exploratory analyses will be performed to investigate other potential clinical endpoints and trends.

RESULTS/CONCLUSION: Similar to previous coronavirus infections, an increased incidence of new-onset neuropathic pain after COVID-19 disease is expected, along with an increase in the severity experienced by patients with COVID-19 with pre-existing chronic pain. Comprehensive understanding of how COVID-19 affects the nervous system can provide a better framework for managing pain in this disease.

PMID:33981939 | PMC:PMC8108598 | DOI:10.1097/PR9.0000000000000925

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Cohort study protocol to characterize the incidence and severity of neuropathic pain in patients with severe acute respiratory syndrome coronavirus 2...

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Opinion Access to health care for undocumented people is both right and smart – The CT Mirror

May 14th, 2021 1:53 am

BRENDA LEON / CONNECTICUT PUBLIC RADIO

Supporters of Senate Bill 956 spoke publicly on the consequences of limited access to health insurance for undocumented immigrants outside the Legislative Office Building in Hartford.

Before the pandemic, Carlos liked playing soccer with his friends and building robots at school. His parents both worked, and provided him with a stable, loving home. Carlos was a healthy and thriving sixth grader. But when I met him, working as his pediatrician in the Intensive Care Unit, he was suffering from kidney failure secondary to complications of COVID-19. Why did this healthy child become so sick?

We discovered that Carlos had an undiagnosed kidney condition that had progressively worsened over the years. Why hadnt this condition been picked up earlier by his pediatrician? Why was Carlos approaching kidney failure when there were readily available treatment options?

Unlike other kids his age, Carlos did not see a pediatrician for regular check-ups. Like other undocumented children in Connecticut, Carlos does not qualify for HUSKY (Health Care for Uninsured Kids and Youth), Connecticuts state-funded health insurance program. For Carlos, and the other 13,000 undocumented children who live in Connecticut, access to affordable routine healthcare is nearly impossible.

With Senate Bill 956, Connecticut has the opportunity to make HUSKY accessible to these children, their parents, and thousands of other undocumented Connecticut residents. I believe that access to healthcare is a basic human right, and Connecticut must provide health insurance to our undocumented neighbors, family members, and friends.

As a pediatrician in New Haven, I worry about our 13,000 undocumented children. Carlos recovered from his acute illness but, unfortunately, now requires dialysis three times a week to live. If Carlos had had regular check-ups with a pediatrician, his kidney disease could have been discovered and treated earlier, and prevented a lengthy hospital admission and lifelong dialysis.

I worry about Carlos, and I also worry about the kids I dont meet. Preventative medicine is at the heart of pediatrics, and kids without health insurance are at risk for worse health outcomes. I see children at regularly scheduled visits from birth through young adulthood. I provide vaccines, screen for developmental delays, manage medical problems, and counsel mental health concerns. Compared with their uninsured peers, insured children are more likely to succeed in school, avoid drug and alcohol use, have more successful careers, and lead healthier adult lives.

The proposed legislation Senate Bill 956 would allow all income-eligible residents to enroll in HUSKY, regardless of citizenship status. To be sure, expanding state-funded health insurance is costly, at an estimated $195 million/year for Connecticut. However, this price tag would be mitigated by future savings on healthcare costs, like uncompensated care. For example, Carloss prolonged hospital stay alone cost just over $1 million. For uninsured patients, the hospital absorbs some cost, while local, state and federal funding sources cover another percentage. Since tax dollars are paying for this care anyway, why not pay for routine health visits upfront, and avoid expensive hospitalizations down the road?

Connecticut, despite a long history of state budget deficits, is now in good financial standing. A recent report projected an extra $925 million in revenues for the current fiscal year, which would wipe out the $640 million projected deficit. In addition, some of those revenues come directly from the taxes paid by the undocumented immigrant community, including Carloss parents. In 2018, undocumented immigrants in Connecticut contributed an estimated $197 million in state and local taxes. This would cover the estimated $195 million annual cost of expanding HUSKY.

My heart breaks for Carlos. His life is forever changed by a condition that could have been prevented by regular check-ups with a pediatrician. Lets work together to bring SB 956 to a vote and pass this bill before the CT General Assembly adjourns on June 9.

What can you do to help? Please write to your state senator and your state representative today. Ask them to vote yeson SB 956. Every Carlos in Connecticut deserves a happy, healthy future.

Dr. Kristin Reese is a pediatrician in New Haven.

CTViewpoints welcomes rebuttal or opposing views to this and all its commentaries. Read our guidelines andsubmit your commentary here.

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Opinion Access to health care for undocumented people is both right and smart - The CT Mirror

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Future Of HealthcareFocus Should Be On Preventative And Holistic Care For All: Viren Shetty – Forbes India

May 14th, 2021 1:53 am

Illustration: Sameer Pawar

What if this pandemic never goes away? I ask a computer screen dotted with pixels somewhat resembling managers and doctors from across our network of hospitals. No response. Nine months into this pandemic and our videoconferencing skills were abortive at best.

What if the world never goes back to normal, and this is what our future looks like? I could sense the mood in the room shift a little, but still no response. I check the audio settings and curse the UX choices of the developers behind our videoconferencing app.

How will our business thrive in a world permanently scarred by Covid-19? I ask as loud as is possible in a professional setting.

The session did not go the way I had hoped it would. Everyone I spoke with maintained that the pandemic was almost over, and that business will get back to normal. I found this hard to believe. This rogue strand of RNA had already humbled the smartest people to ever face a television camera and brought the world economy to its knees. If there is a simple narrative, it would be that the coronavirus controls the world, and we need to do its bidding. The more nuanced narrative is that we will never wake up to a pre-Covid world, and we need to adapt our business to succeed in a new world order dominated by uncertainty. I was hoping we would come up with a better solution than copy-pasting the 2019 business plan for 2021 and hoping for the best.

Nobody knows for certain what this new world looks like, nor do they know how to succeed in that new world. But people like me are paid by their investors to predict the future and we need to have bold and confident strategies like The Future is Digital or We will SaaS our Blockchain on an Electric Cloud. There is footage of me telling news channels quite confidently that masks are not necessary, the coronavirus will be contained to East Asia, and lockdowns will flatten the curve, so my credibility as a Covid expert is quite low. But I have a library full of books which use the words disruptive innovation a lot, so I know exactly what companies that are nothing like mine did 30 years ago to survive in a country with a high ease-of-doing-business score. With the spirits of Harvard strategy professors whispering in my ear, my predictions for Indias future are: 1) Businesses will get disrupted; 2) People will still need health care; and 3) Magazine editors will still want Future of X articles from business leaders.

India has highly skilled doctors, but the pace of their emigration is likely to skyrocket after the pandemic as the West faces a shortage of staffImage: Amarjeet Kumar Singh / Sopa Images / Light Rocket via Getty Images

There are enough beneficiaries of todays technology industry singing paeans to the benefits of technological innovation, but none from the past. I have sourced some of my favourite historical quotes on the topic: Why is that hairless ape carrying a stick twice his size? Last thoughts of the first woolly mammoth to meet the pointy end of a spear.

These printed Bibles sure seem to be getting popular. Should we ban them? Pope Leo X, right before the Protestant Reformation.

What do you mean the ghost people are carrying metal tubes that spit lightning and thunder? Montezuma, last Emperor of the Aztecs.

As history shows us, time and time again, the benefits of disruption usually accrue to the ones doing the disrupting. We do not know what kind of disruption the health care industry will see, but we know that when books are written about us decades from now, we will belong to the Can you believe they used to do this? chapter.

The next decade will see an explosion of software that will help doctors make better clinical decisions

Health care is still very hospital-centric and hospitals are the most expensive places to deliver health care because they have to account for every minor contingency. A hospital in India and a hospital in Germany are made of 90 percent similar components, even though their patients come from two completely different worlds. The cost of delivering health care has increased dramatically, led by higher input costs for drugs and consumables, followed by higher salaries to doctors and nurses working in a riskier clinical environment.

As Indian hospitals become even more specialised, they are leaving poor patients with regular ailments further and further behind. To make things worse, the spend on public health care is not growing as fast as the disease burden. This will keep increasing the quality gap between health care delivered in public hospitals versus private hospitals, which in turn will push the out-of-pocket health care spend, already among the highest in the world, even higher.

Narayana Healths mission is to make high quality health care accessible to everyone. We made a name for ourselves by becoming a focus factory for low-cost surgical procedures and driving down costs through process innovation. We have now reached the limit of how low we can safely drive down costs and every incremental improvement we have rolled out has faced diminishing returns. The flaw lies in the current model of delivering health care, which Dr Robbie Pearl from Kaiser Permanente instead calls delivering sick care. Hospitals focus on delivering surgeries, medicines and procedures to patients in the most efficient way possible. But what if that is the wrong model? What if instead of lowering the cost of a medical procedure, we focus on preventing that procedure from having to take place?

Narayana Health has always looked up to health systems like Kaiser Permanente that manage the entire spectrum of care for their patient members. We believe that a fully integrated health care system that incorporates preventative medicine, primary, secondary and tertiary care in a coordinated manner is more relevant to developing countries like India with a younger and poorer population. This is the only way to ensure that hospitals are completely aligned with a patients long-term incentive to live a healthy life. Narayana Health has begun the process of becoming a fully integrated health care provider and we will know over the next 10 years whether this was the right call.

Digital technology has wreaked havoc across massive industries like transportation, hospitality, food, media, retail and finance, and transformed those industries into something my grandfather would scarcely recognise. There is nothing to suggest that the health care industry will be immune to disruptive innovation coming from non-traditional health care companies catering to the aspirations of a digital-native customer base. There are several billion-dollar health care startups that are bypassing hospitals and offering primary care directly to patients. The largest technology companies in the world have expressed an interest in building a health care vertical and are partnering with health care providers to build solutions that bend the cost/quality curve.

Tech companies need large amounts of patient data and clinical insight to build technology solutions that can automate medical decision-making. The next decade will see an explosion of software that will help doctors make better clinical decisions or empower patients to take care of their own health. It will be interesting to see if tech companies continue working with hospitals once they realise they can sell their products directly to patients or doctors and cut out the intermediary. They do make lovely presentations about being together forever, but we have built a large software development arm of our own. Just in case.

The medical field has benefited immensely from scientific progress and cutting-edge technology that has made it possible to cure diseases that were previously thought incurable. Technologies like CRISPR have the potential to eliminate certain types of cancers and genetic disease. Newer classes of drugs and medical implants can extend the average persons lifespan. None of these were developed in India, and we are completely reliant on universities or companies from the developed world for cutting-edge innovation. Despite our size, we do not have enough specialists available for treating complex diseases and recording their results in a searchable electronic format. The few specialists who are available are too busy treating patients to spend any time doing unremunerated clinical research.India will need to rapidly scale up the medical education and health care infrastructure to 10 times the present size, to have the critical mass of health care professionals required for innovation to flourish. Clinical research is one field that India can dominate because we have the most critical raw ingredientmillions and millions of sick people. Over the coming years, most major Indian hospitals will run large clinical research divisions in partnership with multinational drug companies or foreign universities.

The future holds great promise, but there are several worrying signals for Indian health care in the near term. Our public finances are stretched thin, and the government will be severely constrained in its ability to ramp up health care spending to fund a national procedure reimbursement scheme and a national Covid vaccination programme at the same time. Procedure reimbursements from government programmes have not changed in over seven years, and most hospitals have huge accounts receivable from government payors. Private equity investment into new hospitals has stopped as the ten-year return on capital is less than the cost of capital for greenfield projects. Most of the investment coming into the Indian hospital sector is being used to fund M&A deals, not add more beds.

The part that worries me most is the growing shortage of skilled manpower. The pace of emigration of Indian doctors and nurses will skyrocket after the pandemic as health care systems in the West face staffing shortages from early retirements of their stressed-out health care workers. Medicine is not a preferred option for students from developed countries, and their governments will relax the visa requirements to encourage a large number of skilled doctors and nurses from Asia to fill the gap. India has some of the most highly skilled doctors in the world working in an environment that does not always value their output. Relatively few doctors who graduate become specialists and earn enough to live in a nice neighbourhood, drive a nice car and put their kids in a good school. Those who dont get into artificially scarce postgraduate training programmes will get disheartened and start looking abroad.

History is littered with examples of pandemics reshaping society. The Justinian plagues split the Roman empire and ended the Mediterranean dominance of Europe. The Black Death tilted the feudal compact in favour of the peasants. The Spanish flu spurred the creation of national health care systems and influences hospital design up to the present day. The Covid pandemic has laid bare the fragility of our health care systems and been an equal-opportunity destroyer of rich and poor lives across the country. Through the darkest days of this pandemic, I console myself with the hope that millions of people who have lost someone to Covid are going to find their voice. They will rise up to the people in power and say, Never again. They will demand a better system that provides health care for everyone, because until all of us are safe, none of us are safe.

The writer is executive director and group COO, Narayana Health

(This story appears in the 21 May, 2021 issue of Forbes India. You can buy our tablet version from Magzter.com. To visit our Archives, click here.)

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Ohio bill could expand athletic trainer impact on treating injuries – WCPO

May 14th, 2021 1:52 am

An Ohio bill that expands an athletic trainers ability to help athletes received unanimous support last week as its the first update regulating athletic trainers in three decades, the Journal-News reports.

House Bill 176 would allow licensed athletic trainers the option to enter into a collaboration agreement with a physician or podiatrist to allow that athletic trainer to perform additional services and activities. The bill is jointly sponsored by Reps. Thomas Hall, R-Madison Twp., and Rick Carfagna, R-Genoa Twp., and received 95 votes in support on May 5.

Hall said the bill modernizes the practice act for Ohios athletic trainers in order to better reflect current practice and changes in athletic training education and training.

Carfagna said what athletic trainers are learning now does not match up with what they are permitted to do in the real world.

As we explore ways to stabilize healthcare costs and identify effective pain management techniques, particularly in response to the opioid crisis, expanding access to the expertise provided by athletic trainers will help to keep Ohioans of all ages and abilities healthy and active, he said.

The state has more than 2,300 licensed athletic trainers, and Hall said we should be able to fully utilize athletic trainers and their modern-day skills. Licensed athletic trainers can provide physical medicine and rehabilitation healthcare and partner with physicians to provide preventative services, emergency care, clinical diagnosis, therapeutic intervention, and rehabilitation of injuries and medical conditions.

The bill also makes changes governing the practice of athletic training, including allowing for referrals to athletic training from additional practitioners.

The collaboration agreement between athletic trainers and physicians provides team-based care that is far stronger than any individualized care, said Dr. Benjamin Bring, who is the medical director for the OhioHealth Capital City Half and Quarter Marathon, among other roles. Our goal is to supplement the care we are providing, and we are not replacing physicians. The medical team in sports medicine is always stronger when athletic trainers are involved.

He said the Capital City Half Marathon, which attracts more than 14,000 runners, has a medical team of 70 to 80 healthcare personnel. More than half, he said, are athletic trainers because of their abilities and training with multiple medical issues including heatstroke and hyperthermia, cardiac arrest and CPR, exertional associated collapse, and many other first aid skillsets.

House Bill 176 was introduced into the Ohio Senate on Thursday and has not yet been assigned a committee.

The Journal-News is a media partner of WCPO 9 News.

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How to Advocate for Yourself When You’re Living with a Chronic Illness – Healthline

May 14th, 2021 1:52 am

Good self-advocacy in medical settings requires a complicated balance of confidence and humility.

Can I be honest with you? I dont always like my doctors.

It can be difficult to admit that.

The white lab coat, the bright office full of expensive equipment, and the many, many years of schooling to earn a prestigious degree all loom in my mind when I meet a new doctor.

I see these people through the aura of authority that they cultivated over years of education and practice. Even if I feel uncomfortable with my treatment, it can be hard to give myself permission to look past that glow.

Combine this with whatever powerful emotions I might have about my appointment anxiety, fear, hopefulness and I can become disoriented. I often feel small and uncertain about what I need or want in relation to the health concerns that brought me in.

To be fair, its not just the doctors. I also dont always like my treatments.

Have you ever been prescribed a medication, maybe for pain management or to control symptoms, that you felt ambivalent about?

Maybe youre concerned about possible side effects. Maybe you heard of another option, but its not available because your insurance wont cover it.

Or how about undergoing a new procedure? In non-emergency situations, for exploratory, preventative, or treatment reasons, the choice to put on the hospital gown can be a hard one, even if you know its for your long-term benefit.

Healthcare choices often involve trade-offs. There are risks, benefits, potential side effects, and alternative care options to consider.

Ideally, your doctor should be a compassionate and knowledgeable guide through these tough decisions. Many are. But others dont always have the time or training to do this in the best way possible.

Whats more: At a personal level, we might not always connect well with our doctors. This isnt necessarily their fault. Underneath all that glow, theyre human, too.

Its not wrong to see your doctors as authorities. Theyve earned their credentials through years of study that you and I havent necessarily done, and theyve devoted their lives to caring for others.

We come to them for their vast knowledge in medicine and physiology.

Still, as patients, we have our own forms of knowledge and authority that are grounded in the lived experience of our bodies, our histories, and our hopes for the future.

We know best what pain we feel, what suffering weve lived with, and what we want or can tolerate for our futures.

Chronic pain and illness will undoubtedly change things in ways that are out of our control, but we can still have some decisive power in our health choices.

Sometimes, we have to advocate for ourselves to be able to access that power.

For me, I find that good self-advocacy in medical settings requires a complicated balance of confidence and humility: the confidence to understand and embrace the health choices I make and the humility to realize that Im not an expert in modern medicine even if Im an expert in my own needs.

It doesnt always go like this, but, in the best of scenarios, I want to:

Here are four tips Ive learned that may help you feel more empowered in the process.

This is definitely a knowledge is power situation.

Improve your understanding of your condition and the available treatments by consulting reliable sources.

Websites like Healthline are a great place to start, but also try looking for organizations and resources that are nationally funded or tied to reputable research institutions.

Use this information to ask questions and make strong choices.

Your relationship with your doctor should be collaborative, rather than hierarchical.

To be part of this shared-decision making, seek out doctors who will, within reason and the time constraints of their practice, engage your questions and your right to self-determination.

This is especially important, and often especially challenging, for patients who are Black, Indigenous, or People of Color (BIPOC) with histories of oppression and marginalization in their communities.

Research has shown that racial and ethnic disparities between patient and physician can affect quality of communication, with some evidence that unconscious bias on the part of the physician may be a contributing factor.

Medical and communications research has proposed ways that professionals can overcome this gap through good communication practices that focus on patient empowerment.

Medical concerns are scary. Chronic pain and chronic illness are anxiety provoking and distracting. Theres no way around that.

This can make it hard to focus and make clear decisions in medical settings.

That may be particularly true if youre a person living with a history of trauma or experiences of marginalization by authority figures.

Your discomfort here is like an alarm bell, letting you know you could be in danger. These fears may be realistic or unrealistic, but theyll make it difficult to be present either way.

Partners, friends, and family members can often help you process and untangle your fears and anxieties.

Sometimes, it may feel like youre leaning too hard on your loved ones or that they arent able to support you in the way you need. In this case, support groups, online communities, or even acquaintances or co-workers with similar experiences can be your most trusted allies.

A good therapist can also help.

While youre the authority on your own experiences and feelings, sometimes these can be misleading.

To help balance your feelings with your physical reality, find a way to keep track of your symptoms and interventions in real time by using a measurement thats as objective as you can achieve.

Memory can be tricky, and our emotions can have a big impact on how we experience our symptoms.

For chronic pain, try building a daily log that charts your pain morning, afternoon, and evening on a scale of 1 to 10. List any new treatments or other interventions you tried that day.

Even if you have trouble with this in the moment, looking back at your log can help you judge whether that new regimen of medication, morning yoga, or turmeric tea had any impact over the course of the week.

Health choices usually involve trade-offs, but we can participate fully in the choices we make. Dont be afraid to ask questions and make your own decisions.

Michael Waldon, LMSW is a psychotherapist, writer, and clinical social worker based in New York and California. He is trained in relational, psychodynamic, and somatic psychotherapies. Michael provides individual therapy to clients based in New York and coaching services to clients all over the United States. You can learn more through his website or at Tapestry Psychotherapy, where he maintains a practice specializing in anti-oppressive and integrative approaches to the treatment of trauma.

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Denver Native Serving In The Military Finds Ways To Preserve Mother-Daughter Bond – CBS Denver

May 14th, 2021 1:52 am

(CBS) Mothers Day brings families together, but for those serving in the military overseas it is another holiday apart. One way families try to stay in touch is by recording Mothers Day greetings, which mean a lot to Spc. Samantha Cordova.

Cordova is from Denver, about 7,000 miles away from where she currently serves in the Army in Kuwait. She was deployed over a year ago and has found several ways to stay in touch with her mom.

Weve been able to write letters and call each other on the phone and you have FaceTime calls as well. So, thank God there is some technology there so you can still communicate with each other, Cordova said.

When Cordova joined the military, she was 23 and her mom was the first person she told of her decision to serve her country.

Her response actually shocked me because she said, This is who you were meant to be. This is what you were meant to do, Cordova said.

Filled with encouragement, Cordova decided to see a career as a preventative medicine specialist helping to protect soldiers from any disease, illness or injuries on the base. The hard work is not only gratifying, but it has also grown the bond between mother and daughter.

She was very resilient throughout her entire career. I look up to her and I hope, if I ever become a mother, to be just as strong as she is one day, she said.

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FACT CHECK: Why the EFF is wrong to compare vaccines – Eyewitness News

May 14th, 2021 1:52 am

By researcher Naledi Mashishi

Countries around the world have been racing to vaccinate their populations against COVID-19. South Africas programme started on 17 February 2021. By 10 May, it had vaccinated 395,230 people or 0.7% of its population.

But in April, South Africa suspended the rollout of the Johnson & Johnson vaccine. This was due to a joint advisory by the US Food and Drug Administration and Centers for Disease Control that detailed six cases of blood clotting in women who had received the vaccine.

In response, South African political party the Economic Freedom Fighters issued a statement calling for the government to look at alternatives.

We urge the South African government to consider the Russian and Chinese vaccines, which up to this point, have proven to be of better efficacy than Euro-American vaccines, the statement ended.

Was the party right? We checked.

VACCINES TRAIN THE IMMUNE SYSTEM

A vaccine is a type of preventative medicine that trains the immune system to create antibodies in order to build resistance to specific infections. Most are administered through injection.

Companies that have produced vaccines in Europe and America include: Moderna (US), Pfizer-BioNTech (Germany), AstraZeneca (UK), Johnson & Johnson (US) and Novavax (US).

Companies that have produced vaccines in China and Russia include: Sinopharm (China), Sinovax (China) and Gamaleya (Russia).

MINIMUM 50% EFFICACY REQUIRED

For a vaccine to be approved in South Africa, the South African Health Products Regulatory Authority requires the efficacy to be at least 50%. This is in line with global health standards set by the World Health Organization (WHO).

Dr Lee Hampton, a paediatrician and medical epidemiologist with the Vaccine Alliance, said in an interview with the WHO that vaccine efficacy referred to a vaccines protection against a disease/pathogen in a vaccine trial.

If a vaccine has, for example, 70% efficacy, it means a person vaccinated in a clinical trial is around two-thirds less likely to develop the disease than someone in the trial who didnt get the vaccine.

GERMAN AND US MRNA VACCINES SHOW HIGHEST EFFICACY

Professor Salim Abdool Karim is the director of the Centre for the Aids Programme of Research in South Africa (Caprisa) and has recently been appointed to the WHOs Science Council.

He told Africa Check that the vaccines with the highest efficacy were the two mRNA vaccines: Germanys Pfizer-BioNTech and Moderna from the US. (Note: mRNA vaccines fight diseases by teaching the immune system how to respond to viruses and bacteria. Watch this video to learn more.)

A US trial published on 1 April 2021 found that Pfizer-BioNTechs vaccine had shown 91.3% efficacy against COVID and 95.3% to 100% efficacy against severe disease, depending on the definition used. An Israeli trial published in the Lancet on 5 May 2021 found that the vaccine had shown 95.3% efficacy against COVID-19 infection and 97.5% efficacy against severe COVID.

Modernas vaccine has shown 94.1% efficacy at preventing COVID-19 illness and 100% efficacy against severe COVID.

There are no other COVID-19 vaccines that compare with these two vaccines. All other vaccines, including those developed in Russia and China, have lower levels of efficacy for any symptomatic infections, Karim said.

Russias Sputnik V vaccine has shown 91.6% efficacy against COVID-19 and 100% efficacy against moderate or severe COVID-19.

Chinas Bio-New Crown Vaccine by Sinopharm has shown 79.3% efficacy against COVID-19 and 100% efficacy against moderate and severe COVID-19. (Note: This study has not been published in a peer-reviewed journal.)

CoronaVac by Sinovac has shown 67% efficacy against symptomatic COVID-19, 85% efficacy against hospitalisations and 80% efficacy against death. (Note: These results are from a Chilean study that has not been peer reviewed.)

NO NEED TO COMPARE VACCINES

Despite the differences in efficacy, medical experts and researchers caution against comparing the vaccines. This is because, according to Hampton, the efficacy data is not designed to be compared.

Clinical trials are set up differently and measure different things. All clinical trials provide rigorous data, but it makes it much harder to do direct comparisons between vaccines, he explained.

For this youd need a head-to-head trial, with the same protocol for all the vaccines, delivered and tracked in the same way.

A number of variables can influence the results, including what is considered a COVID-19 case, the study population and statistical methods for efficacy.

Hampton said available data showed that all the vaccines offered better protection against severe illness than symptomatic illness. Given the risks of COVID, he said, he would still advise patients to take vaccines with slightly lower efficacies.

Karim added that there was no need to compare the vaccines.

The level of difference is not really meaningful as these are all highly efficacious, he said. There is no need to compare the Russian and Chinese vaccines to other vaccines as their efficacy data speak for themselves that the vaccines from these two countries are very good vaccines.

SOUTH AFRICAS VARIANT COMPLICATES DATA

Comparisons of vaccine efficacy are further complicated by the 501Y.V2 variant of COVID-19 discovered in South Africa in December 2020.

Professor Hassan Mahomed, a public medicine specialist at the Stellenbosch University Division of Health Systems and Public Health and at the Western Cape provincial department of health, said more research was required to understand the vaccines efficacy in a local setting.

At this stage, few vaccines have released data about their efficacy against the 501Y.V2 variant. Pfizer reported that a small study of 800 people showed that their vaccine was 100% effective in preventing COVID-19 cases in South Africa''.

In peer reviewed published data, the Johnson and Johnson COVID-19 vaccine showed 64% overall efficacy and 82% efficacy against severe disease in South Africa.

Moderna is currently undertaking trials with the South African variant, following early results that suggested it might not be as effective.

There is currently no data on Sputnik or Sinopharms efficacy against the 501Y.V2 variant.

We dont have any data so far about whether [Sputnik] is effective against the variant present here, Mahomed said. It wasnt tested in South Africa at all.

Sinovac has reported that their vaccine remained effective against the 501Y.V2 variant.

CONCLUSION

South Africas Economic Freedom Fighters political party recently claimed that COVID-19 vaccines developed in Russia and China have better efficacy than Euro-American vaccines.

But trials show that the mRNA vaccine developed by Moderna in the United States has higher efficacy than Russian and Chinese vaccines.

But experts say the efficacy of different vaccines should not be compared because their trials were designed differently. The vaccines also need to be tested against the 501Y.V2 variant that has become dominant in South Africa to ensure that they are still effective.

We rate the claim as unproven.

This article appeared on AfricaCheck.org, a non-partisan organisation which promotes accuracy in public debate and the media. Follow them on Twitter: @AfricaCheck

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Beyond Air Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit PRO Programs at ATS 2021 -…

May 14th, 2021 1:52 am

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Interim analysis from the ongoing, open-label, randomized acute viral pneumonia (including COVID-19) pilot study shows 150 ppm nitric oxide (NO) administered with LungFit PRO is well-tolerated with no treatment-related adverse events, and demonstrates encouraging efficacy signals

Further analysis of 3 previously reported pilot studies in bronchiolitis at 150-160 ppm NO demonstrates a favorable safety profile and consistent efficacy across multiple endpoints

Entirety of data at 150-160 ppm NO in both adult and infant patient populations supports further development of LungFit PRO in patients hospitalized with viral pneumonia

GARDEN CITY, N.Y., May 13, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced the presentation of data at the American Thoracic Society (ATS) International Conference 2021, which is being held virtually from May 14 May 19. The data from both LungFit PRO programs, acute viral pneumonia (including COVID-19) and bronchiolitis, show a favorable safety profile and encouraging efficacy trends using high concentration inhaled NO for the treatment of acute viral lung infections in hospitalized patients.

We have now demonstrated a consistently favorable safety profile at high concentrations of nitric oxide in both adult and infant populations with acute viral lung infections, said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. The new data from the acute viral pneumonia pilot trial in adults, taken together with our three previously completed pilot clinical trials in bronchiolitis, enable Beyond Air to prepare for a pivotal study for high concentration NO in a viral indication.

The interim analysis of patients in the acute viral pneumonia (including COVID-19) pilot study shows a favorable safety profile and encouraging efficacy signals in this adult patient population treated with 150 ppm NO generated and delivered by LungFit PRO, commented Andrew Colin, M.D., Batchelor Family Professor of Cystic Fibrosis and Pediatric Pulmonology Director, Division of Pediatric Pulmonology, Miller School of Medicine, University of Miami. Given these current data, I believe the results support the continued development of high concentration inhaled NO that can be delivered with ease by LungFit for the treatment of viral pneumonia including COVID-19. LungFit PRO is a revolutionary device that can allow for the treatment of this diverse patient population on a large scale.

Summary of Interim Results of Acute Viral Pneumonia (including COVID-19) Pilot Trial

The ongoing acute viral pneumonia pilot study is a multi-center, open-label, randomized clinical trial in Israel with an emphasis on enrolling patients infected with SARS-CoV-2. Patients are randomized in a 1:1 ratio to receive inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO + SST) or standard supportive treatment alone (SST, control group). At the time of the cut off for these data, a total of 23 COVID-19 subjects were enrolled. The intent-to-treat (ITT) analysis population included 19 patients (9 NO + SST vs 10 SST).

Safety and Tolerability

Effect on Duration of Hospital Stay Intent to Treat Population

Intent to Treat Population with Exclusion of Extreme Values*

*2 subjects discharged from hospital within 6 hours of study enrollment were excluded from analysis.

Effect on Oxygen Support Requirements

Additional detailed study results will be submitted for presentation at an upcoming scientific meeting.

Summary of Analysis of 3 Completed Bronchiolitis Pilot Trials

To date, over 90 patients hospitalized with a viral lung infection have received 150-160 ppm inhaled NO, dosed intermittently, without any reported treatment-related serious adverse events, said Asher Tal, M.D. Professor Emeritus, Pediatrics, Soroka University Medical Center; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Overall, the data show that 150 ppm NO given intermittently via inhalation is effective in the treatment of patients with bronchiolitis, while data at the lower concentration of 85 ppm show no benefits. I look forward to further development of the program using a minimum concentration of 150 ppm NO, noting that a reduction in time spent in the hospital by these patients would be clinically meaningful.

Beyond Air has assessed inhaled NO in three pilot clinical trials in bronchiolitis. 198 infants (43% females; 57% males) participated across the three programs, with a mean age of 3.9 months (range 0.3 11.9 months). Inhaled NO treatments were given intermittently for 30 to 40 minute durations, from 4 to 5 times daily for up to 5 days. Data from patients in the SST group were pooled across the 3 studies for safety analysis.

Studies Included in the Analysis

Safety and Tolerability

Efficacy Conclusions

*Met statistical significance (p

About Beyond Air, Inc.Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. LungFit can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit for clinical trials for the treatment of severe lung infections such as SARS-CoV-2 and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit http://www.beyondair.net.

About Nitric Oxide (NO)Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.

About LungFit*Beyond Airs LungFit is a cylinder-free, phasic flow nitric oxide generator and delivery system and has been designated as a medical device by the US Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. LungFit system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.

* Beyond Airs LungFit is not approved for commercial use. Beyond Airs LungFit is for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.

About BronchiolitisThe majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Airs system is designed to effectively deliver 150 - 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.

About Acute Viral PneumoniaIn adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options.

About COVID-19COVID-19 (coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 first emerged in December of 2019. Those affected develop fever, cough, shortness of breath and/or difficulty breathing. While the majority of cases result in mild symptoms, some can progress to pneumonia and multi-organ failure. Older adults and people who have serious chronic medical conditions are at an increased risk of developing severe complications from COVID-19. There is no specific treatment approved for COVID-19 and patients are managed with supportive care. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process1,2,3. As of May 12, 2021 more than 160 million confirmed cases of COVID-19 and more than 3.3 million deaths have been reported globally.

[1] Tripathi et al, FEMS Immunology and Medical Microbiology, December 2017[2] Saura, M., et al., An antiviral mechanism of nitric oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8.[3] Akerstrm S et al. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005; 79(3):1966-9.

Forward Looking StatementsThis press release contains forward-looking statements concerning inhaled nitric-oxide and the Companys LungFit product, including statements with regard to potential regulatory developments, the potential impact on patients and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words anticipates, expects, intends, impacts, plans, projects, believes, estimates, likely, goal, assumes, targets and similar expressions and/or the use of future tense or conditional constructions (such as will, may, could, should and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history and other risks identified and described in more detail in the Risk Factors section of the Companys most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACTS:Steven Lisi, Chief Executive Officer Beyond Air, Inc. Slisi@beyondair.net

Maria Yonkoski, Head of Investor RelationsBeyond Air, Inc.Myonkoski@beyondair.net

Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com (212) 915-2577

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Naturdays boozy Frozen Icicles could be the hit of the summer – Yahoo News

May 14th, 2021 1:52 am

The Telegraph

Dean Sherzai, MD, PhD is a neurologist and the co-director of the Alzheimers Prevention Program at Loma Linda University Our brain is the most active organ in our body, consuming 25 per cent of our energy and at times up to 50 per cent of our oxygen, even while we sleep. A balanced diet is crucial for helping it function at its highest capacity, yet all too often brain health is overlooked. So with the help of my wife Ayesha, who studied preventative medicine and neurology, I have devised a diet plan to boost our brain health: The 30-Day Alzheimers Solution: The Definitive Food and Lifestyle Guide to Preventing Cognitive Decline. Alzheimers and dementia are typically problems that are addressed later in life, but the plan is targeted at people of all ages as it is never too early to start feeding your brain: even our children, who are 14 and 16, follow this diet. We dont fall into any one diet plan, as they can all have unhealthy elements. We advocate for a clean, plant-based approach to eating focused around the nine NEURO points: nutrition, exercise, unwind, restore and optimize. The plan also aims to encourage positive habits, such as getting a good nights sleep and eating without your phone. An example of this would be: Nutrition: I will eat three servings of kale per week. Exercise: I will walk briskly for 15 minutes a day, five days a week. Unwind: I will meditate for 10 minutes every day. Restore: I will turn off all device screens an hour before I go to bed every night to help me have a night of restorative sleep. Optimise: I will practice piano three times a week. We chose to keep the plan to 30 days because, based on our experience, that is long enough to create a core set of habits that will last. My wife and I have devoted our careers to exploring the prevention of Alzheimers and other neurodegenerative diseases. What we have discovered is that food is inextricably linked to brain health. Thousands of years ago, the goal was only to live for as long as it took to find a mate, which drove us to seek out sugar and high energy foods. To put it simply, life was about surviving, not thriving. But now, the aim is to cheat that system and live long and healthy lives. If we continue to eat sugars and processed carbohydrates to excess, as is common in Western diets, it can damage your brain. This is partly down to the role of insulin: if you eat too much sugar, the cells become overwhelmed, leading to insulin resistance and diabetes. Diets that are high in saturated fat cause long-term damage to our cells, including oxidation, while too much salt can impair blood pressure and damage the blood vessels leading to the brain. We chose to avoid fish for environmental reasons and concerns about mercury and lead. Instead, our plan incorporates omega-3 into peoples diets through walnuts and supplements. The beauty of the brain is that it can thrive when it is fed with the right foods. These are the neuro nine, which should be eaten every day. 1. Green leafy vegetables This includes dark green leafy vegetables like kale, watercress, Swiss chard, collard greens, arugula and spinach. These contain no saturated fats and help to keep you feeling full; consequently youre less likely to reach for unhealthy foods. They dont release sugar or glucose in excess, so they are the best thing for diabetes, pre-diabetes and glucose metabolism. Aim for: three cups raw or 1.5 cups cooked. 2. Whole grains Such as oats, quinoa, brown rice, farro and buckwheat. The fibre component is crucial, because it is broken down into these short fatty acids that affect the blood/brain barrier. Aim for: three servings ( cup cooked oatmeal, quinoa, brown rice, or 100 per cent whole-wheat pasta is 1 serving). 3. Seeds Especially ground flaxseeds and chia seeds. They have a ratio of omega-3 to omega-6 fatty acids of 34 to 1, making them a powerful brain health food. DHA is the omega-3 that is good for the brain; usually it comes from the algae which fish eat. Flaxseeds also contain lignans, which have antioxidant properties and fight degenerative changes in the body and brain. Aim for: two tablespoons (two servings) 4. Beans and legumes You should aim for a diet that is rich with chickpeas, black beans, pinto beans, lentils, edamame, giant beans, tempeh, tofu. Beans contain resistant starches, fiber, plant proteins, anti-oxidants, phytonutrients and iron. They lower cholesterol, regulate blood sugar and have also been shown to reduce the risk of stroke. Aim for: three servings of 12 cup cooked beans or tofu/tempeh, 14 cup hummus, or 12 cup peas 5. Berries Such as blueberries, blackberries, strawberries. Blueberries contain anthocyanins, which have anti-inflammatory and antioxidant properties. Anthocyanins have also been linked with increased neuronal signaling in areas of the brain that are responsible for memory function, and they improve the delivery of glucose to the brain. Aim for: 12 cup (one serving) 6. Nuts Including walnuts, almonds and cashews. Alongside seeds, these are a source of healthy fat. Walnuts are the stand-out choice when it comes to brain health: they have relatively high amounts of omega-3 fatty acids in the form of ALA as well as fibres and minerals. Walnuts also have the highest antioxidants among all nuts; however, nuts are high in calories so it is important to consume them in moderation. Aim for: 14 cup (one serving) 7. Crucifiers Such as broccoli, cauliflower, bok choy, cabbage and Brussels sprouts. These also have important anti-inflammatories called Sulforaphane, that can access the blood-brain barrier and actually reverse damage caused by free radicals and even normal aging. Aim for: one cup (two servings) 8. Tea Green, white, black, or Oolong tea. Green tea contains catechin, a polyphenol that activates toxin-clearing enzymes. This makes it a great anti-inflammatory. Recent research shows that consuming 1 to 2 cups of green tea a day lowers your risk of Alzheimers and stroke due to the compound EGCC. Aim for: At least one cup daily 9. Herbs and spices Especially turmeric, but also sumac, sage, rosemary, thyme, oregano, cloves, Indian gooseberry, and saffron. We mainly use these in the plan as a replacement for salt, because of the flavour they bring. However, they are also an easy way of adding more anti-inflammatory and antioxidant compounds to your diet. Aim for: At least 14 teaspoon daily The 30-Day Alzheimer's Solution: Definitive Food and Lifestyle Guide to Preventing Cognitive Decline by Dean Sherzai and Ayesha Sherzai is out now (HarperOne) As told to Alice Hall

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From one genomic diagnosis, researchers discover other treatable health conditions – National Human Genome Research Institute

May 14th, 2021 1:52 am

Genome sequencing the ability to sequence an individual's DNA is becoming a standard tool to study diseases. In 2019, over 26 million people took direct-to-consumer DNA tests, which speaks to our collective desire to better understand our genomes.

In July 2013, the American College of Medical Genetics and Genomics issued a recommendation that people who have their genomes sequenced in a clinical setting should also have their genomic data screened for variants in 56 genes that can pose health risks. The genes (which includes the RET gene) are associated with increased risks for several life-threatening, but treatable or preventable diseases. The number of genes included in the list increased to 59 in 2016, and clinicians expect that the list will be updated again soon.

When a person comes into the clinic to be tested for a specific condition, any positive result related to that condition is called a primary finding. But when testing reveals information separate from the original condition, it is called a secondary finding. An estimated 1-4% of people receive unexpected health results from genomic tests each year.

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Animation of a clinician explaining primary and secondary findings. Credit: Harry Wedel, NHGRI.

Secondary findings are not unique to clinical genomics. People can also receive secondary findings from MRI, radiology and other medical tests.

In the case of genome sequencing, examples of secondary findings can include those related to the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer risk, and conditions such as inherited heart rhythm problems. Clinicians share such secondary findings with a person only if the person consents to receiving such information.

Secondary findings are now a component of precision medicine, relying on individual and collective genomic data to make assessments about a persons health risks. Clinicians can obtain highly accurate findings because of the vast amount of available genome sequence data. Researchers can search this data to improve genomic testing and how they detect people who are at risk of harboring disease-related variants. Specifically, secondary findings provide individuals and families the opportunity to learn about their health risks before they develop a disease.

In 2019, researchers at the National Human Genome Research Institute (NHGRI) started the Genomic Services Research Program, part of what is now NHGRI's Center for Precision Health Research, to further understand and improve the implementation of precision medicine initiatives.

"Secondary findings play a pivotal role in diagnosing diseases, preserving health and saving lives," said Leslie Biesecker, M.D., chief of the NHGRIs Clinical Genomics Section. "Our research program measures how clinicians communicate these findings and peoples reactions so we can identify areas for improvement. The payoff could improve human health by making it commonplace for people to get treatment for diseases before they are sick."

The payoff could improve human health by making it commonplace for people to get treatment for diseases before they are sick.

According to Biesecker, identifying a secondary finding is only the first step. The Genomic Services Research Program studies whether secondary findings have real-life use and value by assessing three key components:

Biesecker also emphasized the need for healthcare providers to clearly communicate with patients who receive secondary findings so they understand their treatment options.

"Most people seek out genetic testing because they know of a strong family history for a certain disease," said Katie Lewis, Sc.M., CGC, a genetic counselor in the program. "But for those individuals who get these secondary findings, it can be an immense surprise. Our goal is to help individual patients get the care they need and share the result with their families.

Lewis also adds that there is very little known about the extent to which patients follow through with treatment and the factors that influence their decisions. Understanding what motivates those who do take action and those who do not can help genetic counselors target their efforts to assist an individual with a secondary finding and translate it into improved long-term health.

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Infex Therapeutics appoints Lonza to manufacture new lung infection drug – Business Up North

May 14th, 2021 1:52 am

Infex Therapeutics has awarded a 1m contract to Lonza to help progress its RESP-X program, a novel therapy which targets serious recurrent respiratory infections in patients with damaged lung functions.

RESP-X is expected to enter clinical trials at the Liverpool University Hospital Foundation Trust Clinical Research Facility in November this year.Lonza, the Swiss-owned contract manufacturing company, will manufacture a therapeutic antibody for the program in its plant in Slough, UK.

RESP-X is an anti-virulence therapy in-licensed from Japanese pharma company Shionogi. It is designed to help the body tackle Pseudomonas aeruginosa infections, a hard to treat drug-resistant pathogen recognised by the WHO as a critical threat to human health. A novel humanised monoclonal antibody, RESP-X does not kill bacteria directly but deactivates a mechanism that prevents the immune system from acting against the infection.

Dr Peter Jackson, executive director of Infex Therapeutics, said: Lonza is recognised as a global leader in the manufacture of therapeutic antibodies and we have negotiated this agreement that will provide access to their manufacturing plant within the timeline we need.

Lonza was involved in an earlier stage of the program, producing pre-clinical material at its facility in Singapore, and were very pleased to be able to bring this larger scale body of manufacturing to Lonzas facility in the UK.

RESP-X is designed as a preventative treatment against non-cystic fibrosis bronchiectasis, a long-term condition where the airways of the lungs become abnormally widened, leading to a build-up of excess mucus that can make the lungs more vulnerable to infection. Patients can become chronically infected with Pseudomonas, significantly reducing their quality of life. There is high, unmet need, with millions of patients worldwide at risk of this condition, and no approved preventative therapy.

Jeetendra Vaghjiani, Director Commercial Development, Mammalian at Lonza stated: We are proud to be selected as Infexs manufacturing and development partner for this project. The mission of Infex is an important one and we are happy to collaborate with Infex in this battle against serious infectious disease.

The RESP-X program is backed by iiCON, the infectious disease consortium led by the Liverpool School of Tropical Medicine, supported by the Strength in Places Fund from UKRI.

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From Stress to Healthcare: How COVID-19 Is Impacting People of Color Differently – Healthline

May 14th, 2021 1:52 am

In a new survey, Healthline examined how COVID-19 impacts the mental and physical health of different people by ethnicity. Heres how our findings highlighted the variety of health inequities experienced during the pandemic.

Healthline recently conducted a survey that reveals health inequities by ethnicity.

Comparing data from 1,533 U.S. adults collected in February 2020 with data from 1,577 adults in December 2020, the survey revealed that People of Color (POC) are less likely to rate their overall health and wellness as excellent or very good compared with white Americans.

Moreover, COVID-19 specifically impacted the physical and mental health of POC.

COVID-19 has brought to the forefront a tale of two pandemics. One of which has impacted every major system within our [country]: systemic racism. The other [pandemic], COVID-19, has made the general public aware of the inequities that exist within our systems of care as Black Indigenous Persons of Color (BIPOC) and those that identify as Latino or Latinx have always experienced disproportionate inequities in healthcare, Andrea Heyward, deputy director of the Center for Community Health Alignment, told Healthline.

Healthlines study revealed the following inequalities.

Asian, Hispanic, and Black populations have had more difficulties accessing medical professionals since the pandemic in the following ways:

Inability to see doctors or get treatments:

Delayed doctor or medical appointments due to lack of availability:

Dr. Michelle Ogunwole, health disparities researcher in San Antonio, Texas, noted that some access problems during the early days of the pandemic were due to patient-related reasons, such as being afraid to go to a doctors office for fear of contracting the virus.

Physicians, such as primary care doctors, called to help COVID-19 patients and, therefore, taking appointments only with those who had urgent needs is another reason, she said.

Think about people who get care at federally qualified health centers where the physicians there are already stretched to capacity add in COVID-19, and so it will be difficult to get appointments, and you might have to wait a long time, Ogunwole told Healthline.

Still, she stressed that other reasons related to structural racism are also to blame for lack of access.

Our nation was set up this way. Black and Brown communities live in different areas of town because of redlining and residential segregation, so theyve always had less resources, and the pandemic magnifies this, she said.

For example, hospitals for Black and Brown people have historically been built in the poor parts of town and not invested in. So less innovation occurs, and fewer researchers are inclined to invest in the hospital.

Its a snowball effect. It matters in terms of the quality of care, said Ogunwole.

Dr. Kunjana Mavunda, a pediatric pulmonologist in Miami, agreed. She explained that before the pandemic, clinics that provide care to poor, marginalized groups tend to have long wait times to get appointments, the physical facilities are not well-kept, and the education of the staff might be inadequate.

Due to inadequate financial support, these clinics may not have adequate preventative programs, and when appointments are given, patients have to wait for a long time to be seen which means that a person would have to take a whole day off from work in order to get medical attention, Mavunda told Healthline.

Because of this, patients tend to seek care only when they are sick, and then, they are more likely to go to an urgent care center or emergency room. So, the patient is not able to develop a working relationship with a primary care provider, care is episodic, and there is no continuity of care, she said.

Also, poverty and transportation problems increased during the pandemic, making it difficult for people to keep appointments.

Add in the fact that there is racism and implicit bias on the individual level. There are studies that have shown that peoples biases affect their ability to give the same standard of care to patients, Ogunwole said.

The Healthline survey showed that most POC have felt more anxious and stressed than white Americans over the past few months:

For example, a higher percentage of Asian Americans said they feel stressed. Asians have been falsely blamed for spreading COVID-19 and have been the targets of a higher number of hate crimes during the pandemic.

The COVID-19 pandemic has reinforced not just the longstanding pressure for minorities to assimilate and acculturate in America, but also the absolute demand to assimilate in a way that completely erases cultural history, identities, and practices, Elizabeth Keohan, a licensed certified social worker at Talkspace, told Healthline.

As a result, marginalized groups experience significant levels of stress, anxiety, and depression at a time when personal safety is a persistent concern during everyday life, she said.

It can already be a challenging personal struggle to feel different, separate, and isolated, but when the larger society perceives you as a foreigner in your own land, then emotional stress is raised even higher to a level that can border on an inability to live ones life free of fear, said Keohan.

Heyward added that existing and continuous racial injustices in the United States call for movements such as Black Lives Matter and Stop Asian Hate.

What we know to be true is that stress impacts the health of individuals across a spectrum of conditions, Heyward said. In fact, it is far from surprising that any individual experiencing the stress of COVID-19, lack of access to healthcare, social determinants of health, in addition to experiencing the trauma of prejudice and racism would be impacted physically, emotionally, and psychologically.

While access to healthcare is complicated in many ways, Ogunwole said, the pandemic has shown that change can happen fast.

Systemic change can happen rapidly and overnight because thats what our healthcare system has done this past year, she said.

For instance, telemedicine being covered by Medicaid during the pandemic helped many people.

However, a lot of work needs to be done to help with healthcare disparities long term. Experts believe the following ways can make a difference.

For change to happen, the first step involves intentional and meaningful engagement of people who experience health inequities and racial injustices, said Heyward.

This includes being open to hearing collective voice and tapping into the power of individuals that experience prejudice and racism for any substantial change to happen, she said.

Keohan noted that dialogue connects and sustains people.

Certainly, as humans we cannot heal from what we do not talk about. And after a year of isolation, the wounds of vulnerability have come to the surface, exposing biases, negative worldviews, insecurities, even our own, that may have permeated before now, said Keohan.

Elevating the conversation toward understanding each other can lead to less division and more support for those who need it.

We need to identify and recognize the harshness of our reality, acceptance of what is true and real for so many the ongoing and the wide gaps and disparities in systems of care, Keohan said.

African Americans and Hispanics are often thought of as one unified group, Mavunda said. However, she believes this needs to change.

The thinking process of different groups is different, and it will be more meaningful to look at the groups separately, she said.

For example, American-born African Americans are different from Caribbean Blacks, who are different from Haitian Blacks, who are different from Africans.

Experiences these societies have had for at least the past two to three generations dictate their approach to healthcare, said Mavunda. The same applies to Hispanics recently arrived Cubans are different than Cubans who have grown up in the United States. Puerto Ricans are different than the Mexicans who are different than the Central or South Americans who are different than the Dominicans.

Ogunwole sees differences between POC in her research.

For example, this is a broad generalization, but as a health disparities researcher, a lot of times when you look at the Asian populations health outcomes, if you broke them down into specific subgroups, you would see even more disparities. But they usually tend to be closer to white people than Black and Hispanic people in terms of disparities that we see, she said.

Moreover, she explained that the way People of Color experience racism is different.

We have a shared sense of marginalization, certainly, but the historic roots of racism are very different in the Black community, Latinx community, and the Asian community. In the Black community, it was slavery. In the Asian community, it was the Chinese Exclusions Act. Understanding this is important, she said.

Only 5 percent of U.S. doctors are Black, and according to research from The University of California, Los Angeles (UCLA), the number of doctors who are Black men remains unchanged since 1940.

We know that diversity helps, yet in my specialty, which is internal medicine, the physician population does not yet reflect the patients we see, said Ogunwole.

She explained that physician diversity matters because physicians of color bring new perspectives to medicine and are more likely to work in communities of color.

Theres evidence of increased patient satisfaction when patients share not only racial concordance but language concordance with their doctor, Ogunwole said.

When you look at the projectory of this country, the census is predicting that its going to be a minority-majority by 2050, 2060. Were a melting pot, so we need to have physicians who are reflective of the rich diversity of this country, said Ogunwole.

Being aware of legislation that can impact health and access to health is one way everyone can help, says Mavunda.

Many of our political leaders work to make access to healthcare more difficult. An example is the Florida Legislature. Many years ago, the federal government offered to provide monies to the states to expand Medicaid for the poor and the disabled. Florida has chosen not to accept the money, she said.

She recommended supporting leaders who aim to address disparities as a systemic problem by establishing adequate medical facilities in neighborhoods where people need healthcare and who provide opportunities for patients to build trust with providers.

Unfortunately, this requires money, and changes need to be made at governmental levels state, federal, local, etc. Not all leaders are willing to make changes or spend money on all communities. We know that this will work because we have pockets where this is already happening, e.g., clinics that treat the migrants and federally funded clinics located in poor neighborhoods, Mavunda said.

For mental healthcare needs, Keohan suggested identifying what is available to you, within your own network of care, and also within your community to help ease the search.

When performing an online search, enter clinician of color or BIPOC therapist of color.

Ask questions about worldviews, approach and style to understand that a particular provider might be better equipped to understand and validate the stressors you might be experiencing both personally and also through a broader scope of gender, race, faith, and sexuality, said Keohan.

Once you can identify what matters to you, it can be easier to eliminate the wrong provider and find one who can support and compliment your value, she added.

When scheduling visits with a new clinic, Ogunwole said there is nothing wrong with saying, Id like to request a bilingual provider, or Id like to request a Black woman provider, or Id like to request a provider who is comfortable treating transgender youth.

Its not always that youll get a doctor who looks exactly like you. Its about finding a doctor who cares about your well-being, and who can suspend judgment, and who is willing to listen to you and include you in the conversation about your health, Keohan said.

Heyward suggested reaching out to a community health worker (CHWs), people with lived experience who have strong ties to the community they serve.

As community leaders and advocates in many areas, CHWs help individuals every day in navigating healthcare and social needs, she said.

To learn more about CHWs and other community resources, including those for COVID-19, visit their website.

Cathy Cassata is a freelance writer who specializes in stories around health, mental health, medical news, and inspirational people. She writes with empathy and accuracy and has a knack for connecting with readers in an insightful and engaging way. Read more of her work here.

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VA focused on COVID-19 while providing care | News, Sports, Jobs – Escanaba Daily Press

May 14th, 2021 1:52 am

ESCANABA It has been more than 15 months since our nation began its fight against COVID-19. Weve prevented infections, cared for the sick, saved lives and mourned those weve lost. Weve provided so much more than medicine during this time as loved ones supported from a distance. The burdens and responsibilities of the pandemic have strained organizations, families, and each of us in very personal ways. Now, as more than 2.3 million veterans across the nation have been fully vaccinated trust and confidence in VA health care is at an all-time high.

Our health care teams at the Oscar G. Johnson VA Medical Center here in Iron Mountain have earned that trust, working on the frontlines to provide care to those most in need. We began implementing safety measures over a year ago to protect Veterans and our staff from getting sick. As part of prioritizing safety, for each appointment weve had to weigh the options and risks with our patients. When clinical urgency rose above the risk of COVID-19, we provided in person care. When it did not and the risk of COVID-19 infection took priority, we offered alternatives. This was the right decision. In many cases, Veterans told us they preferred postponing routine care because they did not want to risk being exposed to the virus and we worked with them to identify next steps.

We successfully moved many appointments to video and telephone when that was appropriate and helped meet the needs of the patient. This has even offered unexpected benefits of convenience for veterans or additional engagement options for family and caregivers. Unlike with in person care, virtual options give a Veterans support network the ability to join visits and engage with VA providers much more easily. We anticipate continuing to offer virtual visits even as we return to more in person care.

As we move forward, we are welcoming veterans back in record numbers. We are encouraging veterans to call first and talk to their health care team about coming in for routine and preventative care. These appointments, from cancer screenings to eye exams are essential to staying healthy and ultimately save lives.

Here at OGJVAMC, we have reached out to patients to be sure they are getting the care they need and working with them to reschedule appointments. As our community spread of COVID-19 has decreased over the past few months, many have already resumed their care, while others have begun scheduling appointments for the weeks ahead, either within the VA or when eligible, in the community.

In working to coordinate care, we have found that many community providers outside of VA are also needing to reschedule previously cancelled appointments or are managing abbreviated schedules, creating longer wait times than usual and often longer than within VA. We have provided more than 2.3 million Veterans care in the community since the MISSION Act was implemented almost two years ago, and we are proud that so many Veterans continue to choose VA, allowing us to coordinate timely, quality and patient-focused care inside or outside our walls.

I want this community to know that OGJVAMC is dedicated to caring for Veterans, not just in this time of national emergency, but continuing now and into the future. While we are part of the national healthcare system, first and foremost, we are members of this vibrant community. OGJVAMCs 700 employees are here day and night for those who have served our nation and call the Upper Peninsula and northern Wisconsin home.

Recent legislation has enabled us to open up vaccination clinics to any Veteran along with their spouse or caregiver, and we are pleased to be meeting new members of this community for the first time, or welcoming back those who we havent seen in a while. We would encourage every Veteran to consider coming in and receiving their COVID-19 vaccine and enrolling in care with us. If you or a Veteran in your life havent come in for care in a while, please check in with your provider team and consider scheduling an appointment. If you know a veteran who isnt enrolled in VA health care and is interested in their eligibility, please direct them to http://www.VA.gov.

I hope Veterans and all members of the community will take the time to work with their medical provider team to get their appointments rescheduled, even if they havent been vaccinated yet. Our doors are open, and we look forward to seeing you soon.

Jim Rice is director of the Oscar G. Johnson VA Medical Center in Iron Mountain

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How the bubonic plague changed drinking habits – The Conversation UK

May 14th, 2021 1:52 am

Alcohol deaths in England and Wales in 2020 were the highest for 20 years. The Office for National Statistics recorded 7,423 deaths from alcohol misuse, a 19.6% increase compared with 2019. Although this is likely to have many complex causes, data from Public Health England suggests that the COVID-19 pandemic and its resulting lockdowns are at least partly responsible for the increase. Largely, the disruption of work and social routines have led to a surge of hazardous drinking within the home (with some fairly harrowing personal stories).

The Intoxicating Spaces project, of which Im part, has been exploring how pandemics also influenced the use of intoxicants, including patterns of alcohol consumption, in the past. As part of this work, weve looked at how the successive bubonic plague outbreaks that gripped England, especially London, in the 17th century (1603, 1625, 1636 and 1665) wrought similar changes in peoples drinking habits.

Like today, these sudden and frightening outbreaks of disease restricted access to inns, taverns, alehouses and other public drinking places the cornerstones of early-modern sociability. While never subject to wholesale closure, these environments were targeted by the equivalent of social distancing legislation. A 1665 London plague order, for example, identified tippling in taverns, alehouses, coffee-houses, and cellars as the greatest occasion of dispersing the plague, and imposed a 9pm curfew.

The extent to which these regulations altered 17th-century peoples relationship with alcohol is difficult to determine based on surviving information. However, anecdotal evidence suggests there might have been a comparable shift towards drinking at home.

In his classic 1722 meditation on the 1665 London outbreak Due Preparations for the Plague, Daniel Defoe told the story of a London grocer who voluntarily quarantined himself and his family in their home for the duration of the pandemic. Among the provisions he assembled were 12 hogsheads of beer; casks and rundlets containing four varieties of wine (canary, malmsey, sack and tent; 16 gallons of brandy; and many sorts of distilld waters (spirits).

According to Defoe, this impressive stockpile was not gratuitous but necessary supplies. This is because, surprisingly from the perspective of todays public health messaging, in this period alcohol was thought to have had medicinal value and its moderate consumption during plague outbreaks was actively encouraged.

Contemporary doctors and medical writers believed alcohol worked as a plague preventatives, in two main ways.

First, the consumption of beers, wines and spirits was believed to strengthen the bodys key defensive organs of the brain, heart and liver. They were especially beneficial when taken first thing in the morning, with many commentators recommending fortifying liquid plague breakfasts.

In his 1665 plague treatise, Medela Pestilentiae, minister and medical writer Richard Kephale claimed that its good to drink a pint of maligo [Malaga wine or port] in the morning against the infection. (He was also effusive on the inexpressible virtues of tobacco.) Many recipes for the popular preventative and cure plague water invariably contain wine and spirits, as well as pharmaceutical herbs.

Second, and perhaps more significantly, moderate drinking was believed to ward off those fearful mental states that induced melancholy (early modern terminology for depression), which was thought to make people more vulnerable to contracting the plague.

As Defoe put it, the grocers liquor hoard was not for his and his familys mirth or plentiful drinking, but rather so as not to suffer their spirits to sink or be dejected, as on such melancholy occasions they might be supposed to do. Likewise, in his 1665 plague treatise, Zenexton Ante-Pestilentiale, physician William Simpson advocated the drinking of good wholesome well-spirited liquor to make the heart merry and cause cheerfulness. This would banish many enormous ideas of fear, hatred, anxiousness, sorrow, and other perplexing thoughts, and thereby fortify the balsam of life against all infectious breaths.

The key thing for all of these writers was alcohol moderately taken. Excessive drinking to the point of drunkenness was still cautioned against, and living with temperance upon a good generous diet (in the words of one author) remained the baseline for most plague medicine.

However, then as now, its likely that the disruption of patterns of labour and leisure, along with the daily anxieties of living in a plague-stricken city, drove many to the psychological consolations of the bottle on a more dangerous and habitual basis. In A Journal of the Plague Year Defoes other, more celebrated novel about the 1665 London outbreak he tells the story of a physician who kept his spirits always high and hot with cordials and wine. But could not leave them off when the infection was quite gone, and so became a sot for all his life after.

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How the bubonic plague changed drinking habits - The Conversation UK

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How Big Data Are Unlocking the Mysteries of Autism – Scientific American

May 2nd, 2021 1:57 am

When I started my pediatric genetic practice over 20 years ago, I was frustrated by constantly having to tell families and patients that I couldnt answer many of their questions about autism and what the future held for them. What were the causes of their childs particular behavioral and medical challenges? Would their child talk? Have seizures? What I did know was that research was the key to unlocking the mysteries of a remarkably heterogeneous disorder that affects more than five million Americans and has no FDA-approved treatments. Now, thanks in large part to the impact of genetic research, those answers are starting to come into focus.

Five years ago we launched SPARK ( Simons Foundation Powering Autism Research for Knowledge) to harness the power of big data by engaging hundreds of thousands of individuals with autism and their family members to participate in research. The more people who participate, the deeper and richer these data sets become, catalyzing research that is expanding our knowledge of both biology and behavior to develop more precise approaches to medical and behavioral issues.

SPARK is the worlds largest autism research study to date with over 250,000 participants, more than 100,000 of whom have provided DNA samples through the simple act of spitting in a tube. We have generated genomic data that have been de-identified and made available to qualified researchers. SPARK has itself been able to analyze 19,000 genes to find possible connections to autism; worked with 31 of the nations leading medical schools and autism research centers; and helped thousands of participating families enroll in nearly 100 additional autism research studies.

Genetic research has taught us that what we commonly call autism is actually a spectrum of hundreds of conditions that vary widely among adults and children. Across this spectrum, individuals share core symptoms and challenges with social interaction, restricted interests and/or repetitive behaviors.

We now know that genes play a central role in the causes of these autisms, which are the result of genetic changes in combination with other causes including prenatal factors. To date, research employing data science and machine learning has identified approximately 150 genes related to autism, but suggests there may be as many as 500 or more. Finding additional genes and commonalities among individuals who share similar genetic differences is crucial to advancing autism research and developing improved supports and treatments. Essentially, we will take a page from the playbook that oncologists use to treat certain types of cancer based upon their genetic signatures and apply targeted therapeutic strategies to help people with autism.

But in order to get answers faster and be certain of these results, SPARK and our research partners need a huge sample size: bigger data. To ensure an accurate inventory of all the major genetic contributors, and learn if and how different genetic variants contribute to autistic behaviors, we need not only the largest but also the most diverse group of participants.

The genetic, medical and behavioral data SPARK collects from people with autism and their families is rich in detail and can be leveraged by many different investigators. Access to rich data sets draws talented scientists to the field of autism science to develop new methods of finding patterns in the data, better predicting associated behavioral and medical issues, and, perhaps, identifying more effective supports and treatments.

Genetic research is already providing answers and insights about prognosis. For example, one SPARK familys genetic result is strongly associated with a lack of spoken language but an ability to understand language. Armed with this information, the medical team provided the child with an assistive communication device that decreased tantrums that arose from the childs frustration at being unable to express himself. An adult who was diagnosed at age 11 with a form of autism that used to be known as Aspergers syndrome recently learned that the cause of her autism is KMT2C-related syndrome, a rare genetic disorder caused by changes in the gene KMT2C.

Some genetic syndromes associated with autism also confer cancer risks, so receiving these results is particularlyimportant. We have returned genetic results to families with mutations in PTEN, which is associated with a higher risk of breast, thyroid, kidney and uterine cancer. A genetic diagnosis means that they can now be screened earlier and more frequently for specific cancers.

In other cases, SPARK has identified genetic causes of autism that can be treated. Through whole exome sequencing, SPARK identified a case of phenylketonuria (PKU) that was missed during newborn screening. This inherited disorder causes a buildup of amino acid in the blood, which can cause behavior and movement problems, seizures and developmental disabilities. With this knowledge, the family started their child on treatment with a specialized diet including low levels of phenylalanine.

Today, thanks to a growing community of families affected by autism who, literally, give a part of themselves to help understand the vast complexities of autism, I can tell about 10 percent of parents what genetic change caused their childs autism.

We know that big data, with each person representing their unique profile of someone impacted by autism, will lead to many of the answers we seek. Better genetic insights, gleaned through complex analysis of rich data, will help provide the means to support individualschildren and adults across the spectrumthrough early intervention, assistive communication, tailored education and, someday, genetically-based treatments. We strive to enable every person with autism to be the best possible version of themselves.

This is an opinion and analysis article.

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How Big Data Are Unlocking the Mysteries of Autism - Scientific American

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Demand for Genetic and DNA Testing Spurring Adoption of Genealogy Products and Services: Fact.MR – BioSpace

May 2nd, 2021 1:57 am

Surging demand for genetic and DNA testing and integration of big data science in genetic are creating lucrative opportunities

Fact.MR, Rockville MD: Fact.MRs recent study on the global genealogy products and services market has projected the market to grow at a healthy pace through 2021. Surging demand for genetics and DNA testing in the developed countries is anticipated to drive the market demand through 2021. Rising prevalence of genetic diseases such as autoimmune disease, cancer, diabetes has majorly augmented the demand for genetic testing across the globe. According to the study, the market is significantly fragmented and with leading players establishing their online presence in various regions is helping the market to grow rapidly.

Furthermore, genetic and DNA testing plays a vital role for the early diagnostics and preventive healthcare in case of rare autoimmune diseases, which is aiding the market demand. Also, the adoption of artificial intelligence and data science has provided ample of expansion opportunities to the market players. The growth of the market is highly dependent on the growth of Artificial Intelligence and information technology. Also, demand for genealogy in tracing lineage with the help of big data analytics has provided wide growth opportunities for genealogy products and services manufacturers.

Request a report sample to gain comprehensive insights at

https://www.factmr.com/connectus/sample?flag=S&rep_id=3083

DNA and genetic testing are finding lucrative opportunities in the field of forensics as they adopt advance technologies to enhance the efficiency of investigation. This is boosting the adoption genealogy products and services in the forensics domain, says the Fact.MR analyst.

Key Takeaways

Prominent Drivers

Key Restraints

Discover more about the Genealogy products and services market with 32 figures, data tables and the table of contents.

https://www.factmr.com/report/3083/genealogy-products-services-market

Competitive Landscape

Key market players listed by Fact.MR for global genealogy products and services market includes MyHeriatge, WHSmith, 23andMe Inc., FamilySearch, Geneanet, WikiTree, FindmyPast, GenealogyBank, Living DNA, Billion Graves, and Family Tree DNA among others. According to the study, the market is expected to be fragmented. Key players are focused bolstering their online presence along with new product launches and novel services to attract more customer base.

For instance, in December 2020, Blackstone completed the acquisition of Ancestry, an online global leader in digital family history business, operating in more than 30 countries, for the price of US$ 4.7 Billion.

Also in 2019, Bode Technology, a leading provider of forensic DNA analysis products and services announced the launch of new forensic genealogy service offering to the law enforcement investigators and crime laboratories.

More Insights on the Genealogy products and services Market

In its latest report on genealogy products and services market, Fact.MR gives a detailed segmentation on the key growth drivers and opportunities expected to prevail the market in upcoming years. In order to understand the market perspective, trends and challenges, the market is segmented on the basis of category (family records, family tree, forum, cemetery, newspapers, blogs, links, and DNA testing), and across major regions (North America, Latin America, Europe, Asia Pacific and Middle East & Africa).

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Explore Fact.MRs Coverage on the Healthcare Domain

Genetic Testing Services Market: A recent study by Fact.MR on the genetic testing services market offers an unbiased analysis on the opportunities and trends through 2021 and beyond. The study analyzes crucial trends that are currently determining market growth. This report explicates on vital dynamics, such as the challenges, restraints, and opportunities for key market players along with key stakeholders and emerging players.

Genetic Analyzer Systems Market: Fact.MR gives a detailed assessment of Genetic analyzer systems market value chain analysis, business execution, and supply chain analysis across regional markets has been covered in the report. A list of prominent companies operating in the market along with their product portfolios enhances the reliability of this comprehensive research study.

Genetic Testing Panels Market: Fact.MR delivers an in-depth analysis on global genetic testing panels market with the strategies and competitive landscape through 2021 and beyond. The key players market share data provided by the report given you a detailed insights on the shortcomings and forthcomings of the market for the forecast period.

About Fact.MR

Market research and consulting agency with a difference! Thats why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Reach out to us with your goals, and well be an able research partner.

Contact:US Sales Office: 11140 Rockville PikeSuite 400Rockville, MD 20852United StatesTel: +1 (628) 251-1583E: sales@factmr.comFollow Us:LinkedIn | TwitterSource: Fact.MR

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Demand for Genetic and DNA Testing Spurring Adoption of Genealogy Products and Services: Fact.MR - BioSpace

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Researchers Create CRISPR ‘On-Off Switch’ to Control Inherited Genetic Problems Without Changing DNA – Good News Network

May 2nd, 2021 1:57 am

Scientists have figured out how to modify the unrivaled gene-editing tool CRISPR to extend its reach to the epigenome, which controls how genes are switched on or off.

The researchers from the University of California, San Francisco, and MITs non-profit Whitehead Institute for Biomedical Research and have already used the tool in the lab to mostly deactivate the gene that makes the protein Tau, which has been implicated in Alzheimers disease.

The novel CRISPR-based tool called CRISPRoff allows scientists to switch off almost any gene in human cells without making a single edit to the genetic codeand once a gene is switched off, it remains inert in the cells descendants for hundreds of generations, unless it is switched back on with a complementary tool called CRISPRon.

Because the epigenome plays a central role in many diseases, from viral infection to cancer, CRISPRoff technology may one day lead to powerful epigenetic therapies that are safer than conventional CRISPR therapeutics because it doesnt involve any DNA edits.

Though genetic and cellular therapies are the future of medicine, there are potential safety concerns around permanently changing the genome, which is why were trying to come up with other ways to use CRISPR to treat disease, said Luke Gilbert, PhD, a professor at UCSF and co-senior author of the new paper, published in the April 9 journal Cell.

Conventional CRISPR is equipped with two pieces of molecular hardware that make it an effective gene-editing tool. One component is a DNA-snipping enzyme, which gives CRISPR the ability to alter DNA sequences. The other is a homing device that can be programmed to zero in on any DNA sequence of interest, imparting precise control over where edits are made.

RELATED: Every Patient Treated With CRISPR Gene Therapy for Blood Diseases Continues to Thrive, More Than a Year On

To build CRISPRoff, the researchers dispensed with conventional CRISPRs DNA-snipping enzyme function, but retained the homing device, creating a stripped-down CRISPR capable of targeting any gene. Then they tethered an enzyme to this barebones CRISPR. But rather than splicing DNA, this enzyme acts on the epigenome, which consists of proteins and small molecules that latch onto DNA and control when and where genes are switched on or off.

The new tool targets a particular epigenetic feature known as DNA methylation, which is one of many molecular parts of the epigenome. When DNA is methylated, a small chemical tag known as a methyl group is affixed to DNA, which silences nearby genes. Although DNA methylation occurs naturally in all mammalian cells, CRISPRoff offers scientists unprecedented control over this process.

Another tool described in the paper, called CRISPRon, removes methylation marks deposited by CRISPRoff, making the process fully reversible.

Now we have a simple tool that can silence the vast majority of genes, said Jonathan Weissman, PhD, Whitehead Institute member, co-senior author of the new paper and a former UCSF faculty member. We can do this for multiple genes at the same time without any DNA damage, and in a way that can be reversed. Its a great tool for controlling gene expression.

Based on previous work by a group in Italy, the researchers were confident that CRISPRoff would be able to silence specific genes, but they suspected that some 30 percent of human genes would be unresponsive to the new tool.

POPULR: Scientists Use Gene-targeting Breakthrough Against COVID-19 Cells With CRISPR Tool Called PAC-MAN

DNA consists of four genetic letters A, C, G, T but, in general, only Cs next to Gs can be methylated. To complicate matters, scientists have long believed that methylation could only silence genes at sites in the genome where CG sequences are highly concentrated, regions known as CpG islands.

Since nearly a third of human genes lack CpG islands, the researchers assumed methylation wouldnt switch these genes off. But their CRISPRoff experiments upended this epigenetic dogma.

What was thought before this work was that the 30 percent of genes that do not have CpG islands were not controlled by DNA methylation, said Gilbert. But our work clearly shows that you dont require a CpG island to turn genes off by methylation. That, to me, was a major surprise.

Easy-to-use epigenetic editors like CRISPRoff have tremendous therapeutic potential, in large part because, like the genome, the epigenome can be inherited.

MORE: Revolutionary CRISPR-based Genome Editing System Destroys Cancer Cells Permanently in Lab

When CRISPRoff silences a gene, not only does the gene remain off in the treated cell, it also stays off in the descendants of the cell as it divides, for as many as 450 generations.

To the researchers surprise, this held true even in maturing stem cells. Though the transition from stem cell to differentiated adult cell involves a significant rewiring of the epigenome, the methylation marks deposited by CRISPRoff were faithfully inherited in 90 percent of cells that made this transition, which showed that cells retain a memory of epigenetic modifications made by the CRISPRoff system even as they change cell type.

They selected one gene to use as an example of how CRISPRoff might be applied to therapeutics: the gene that codes for Tau protein, which is implicated in Alzheimers disease. After testing the method in neurons, they discovered that using CRISPRoff could be used to turn Tau expression downalthough not entirely off. What we showed is that this is a viable strategy for silencing Tau and preventing that protein from being expressed, says Weissman. The question is, then, how do you deliver this to an adult? And would it really be enough to impact Alzheimers? Those are big open questions, especially the latter.

Even if CRISPRoff does not lead to Alzheimers therapies, there are many other conditions it could potentially be applied to. Their findings suggest that CRISPRoff would only need to be administered once to have lasting therapeutic effects, making it a promising approach for treating rare genetic disorders including Marfan syndrome, which affects connective tissue, Jobs syndrome, an immune system disorder, and certain forms of cancer that are caused by the activity of a single damaged copy of a gene.

ALSO: For First Time Ever, Scientists Have Cured Living Creatures of HIV and Eliminated Virus From DNA Entirely

While delivery to specific tissues remains a challenge, we showed that you can deliver it transiently as a DNA or as an RNA, the same technology thats the basis of the Moderna and BioNTech coronavirus vaccine, Weissman says.

Because the epigenome plays a central role in so many diseases, this exciting new technology may one day lead to powerful therapies to tackle our deadliest foes, although further work is needed to realize its full therapeutic potential.

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