StemCell Therapy

TEMPLE CITY, Calif., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics (Nasdaq: FLGT) and New York City Health and Hospitals have announced they will provide COVID-19 testing to hundreds of thousands of students across approximately 1600 locations as they return to school in September and over the next several months. Fulgent will provide its FDA EUA-approved at-home test, Picture by Fulgent, a RT-PCR test that provides the highest level of sensitivity and specificity, utilizing a self-collected nasal swab sample. Fulgent will provide results within 24-48 hours from the time when Fulgent receives and accepts a specimen for the test.

Fulgent is very happy to partner with the City of New York on such an important and novel testing protocol. Its an ambitious goal to test so many students in such a rapid fashion, but the combination of the Fulgent technology platform and lab capacity along with the strong testing infrastructure of New York City makes this possible, commented Brandon Perthuis, Chief Commercial Officer of Fulgent Genetics. In just a few short days, we were able to get the first shipment of hundreds of thousands of Picture kits to New York City. We will now be working closely with the city on the distribution, return and replenishment of the kits, added Perthuis.

This is one of the first large-scale testing programs for COVID-19 to utilize an at-home test kit. Fulgents Picture Genetics at-home test was chosen due to its convenient self-administration, which can be used on-site at schools as well as at home. The companys industry-leading turnaround time of 24-48 hours also makes this a powerful tool for back-to-school testing.

About NYC Test & Trace Corps

The NYC Test & Trace Corps is a public health initiative to fight COVID-19 so that New Yorkers can get back to school, work and help New York City reopen safely. The Corps is a group of doctors, public health professionals and community advocates working to reverse the COVID-19 outbreak and protect our city. The public health program is led by NYC Health + Hospitals in close collaboration with the NYC Department of Health and Mental Hygiene and other city agencies. Through its robust and citywide partnerships, The Corps helps New Yorkers receive free, safe and confidential testing for COVID-19 and for the antibody test. It ensures that anyone with the virus receives care and can safely isolate to prevent the spread. For more information, visit https://www.nychealthandhospitals.org/test-and-trace/.

About Fulgent Genetics

Fulgent Genetics proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy and competitive turnaround times. Combining next generation sequencing (NGS) with its technology platform, the Company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. In 2019, the Company launched its first patient-initiated product, Picture Genetics, a new line of at-home screening tests that combines the Companys advanced NGS solutions with actionable results and genetic counseling options for individuals. Since March 2020, the Company has commercially launched several tests for the detection of SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19), including NGS and reverse transcription polymerase chain reaction (RT-PCR) - based tests. The Company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the RT-PCR-based tests for the detection of SARS-CoV-2 using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs) and for the at-home testing service through Picture Genetics. A cornerstone of the Companys business is its ability to provide expansive options and flexibility for all clients unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated lab services.

About Picture Genetics

Through its Picture Genetics platform launched in 2019, Fulgent Genetics offers consumers direct access to its advanced genetic testing and analytics capabilities from the ease and comfort of home, at an affordable price point. The Picture Genetics platform provides a holistic approach to at-home genetic screening by including oversight from independent physicians as well as genetic counseling options to complement Fulgent Genetics comprehensive genetic testing analysis. The Picture Genetics platform currently offers multiple tests, providing medically actionable, clinical-level results with professional medical follow-up in one easy process. Visit http://www.picturegenetics.comfor more information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: the companys identification and evaluation of opportunities and its ability to capitalize on opportunities to grow its business; expected future lab capacity and turnaround times; expectations or guidance regarding future revenues and managements judgements and evaluations of the companys platform and technology.

Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the companys future performance, and they are based on managements current assumptions, expectations and beliefs concerning future developments and their potential effect on the companys business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its tests and the pandemics effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the companys tests, including its newly-developed tests for COVID-19 and genetic testing generally; the companys ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets, including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the companys ability to maintain the low internal costs of its business model, particularly as the company makes investments across its business; the companys ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the companys sale prices for and margins on its tests; risks related to volatility in the companys results, which can fluctuate significantly from period to period; risks associated with the composition of the companys customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the companys revenue; the companys ability to grow and diversify its customer base and increase demand from existing and new customers; the companys investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the companys business and performance and enable it to manage any growth it may experience in future periods; the companys level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the companys level of success in establishing and obtaining the intended benefits from partnerships, joint ventures or other relationships; the companys compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the companys international operations; the companys ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and the company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

The companys reports filed with the U.S. Securities and Exchange Commission (SEC), including its annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020 and the other reports it files from time to time, including subsequently filed quarterly and current reports, are made available on the companys website upon their filing with the SEC. These reports contain more information about the company, its business and the risks affecting its business.

Investor Relations Contact:The Blueshirt GroupMelanie Solomon, 415-217-4964, melanie@blueshirtgroup.com

Media Contact:The Blueshirt GroupJeff Fox, 415-828-8298, jeff@blueshirtgroup.com

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Fulgent Genetics, New York City Health and Hospitals Partner on Large-Scale Back-to-School COVID-19 Testing - GlobeNewswire

In the last days of the most recent legislative session, the California State Legislature was busy passing several privacy bills set to impact businesses. The most recent, the Genetic Information Privacy Act, would require companies that sell and market consumer-focused genetic testing products directly to consumers (including COVID-19 testing companies) to comply with certain privacy requirements.

If signed by Governor Newsom, the Genetic Information Privacy Act will require the following:

The responsibilities set upon businesses and the rights afforded to consumers reflect a pattern emerging in consumer privacy legislation, most notably, the California Consumer Privacy Act, which went into effect on January 1, 2020, and into full enforcement on August 14, 2020.

The Act goes further to ensure that consumers genetic data will not be disclosed to health insurers, insurance providers, or employers who may make decisions regarding provision of coverage or employment to an individual consumer.

With the adaptation and growth of testing companies that have emerged in the wake of COVID-19, established businesses and startups alike must heed this new regulation.

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Genetic and COVID-19 Testing Companies Set To Be Regulated in California - JD Supra

Lung cancer cells invade surrounding tissues and start to spread.Image courtesy of the National Cancer Institute

A malignant tumor is a bustling metropolis populated by many different kinds of cancer cells. This cellular diversity, however, is what makes cancer so difficult to treat, as each type of cell in a tumor responds differently and sometimes not at all to cancer therapies. This is especially true for lung cancer, which often responds to an initial course of treatment, only to remerge after becoming drug-resistant, making it the deadliest form of cancer worldwide.

A better understanding of the diversity that exists within a lung tumor would likely lead to more effective treatments. Today, clinicians generally rely on tests that generate genetic profiles of biopsied tumors in bulk rather than one cell at a time. Unfortunately, this usually fails to capture the full extent of cellular diversity within tumors and ends up obscuring clinically significant information. This has led scientists to search for ways to assemble a census of the many types of cells that comprise a malignant tumor. Even better would be a more complete picture of how these cell populations evolve during the course of treatment. However, figuring out exactly how to conduct this survey has proven to be a major technical barrier for scientists.

But this hurdle, once thought to be nearly insurmountable, was recently cleared by a research team led by UC San Francisco and Chan Zuckerberg Biohub scientists. The researchers figured out how to assemble genetic profiles of individual lung cancer cells obtained from patients at different times during the course of their treatment. In doing so, they revealed a vast cornucopia of cellular diversity in both lung tumors and the tissue surrounding the tumor as they evolved during the course of treatment clinically significant information that had previously eluded scientists. The findings are detailed in a paper published Aug. 20 in the journal Cell.

This study is among the first of its kind, said Trever Bivona, MD, PhD, professor of medicine and senior author of the study. We observed features of lung cancer cells and the tumor microenvironment that no one had seen before. This gave us a window into the evolution of individual cells within the tumors ecosystem.

Starting with 49 biopsies obtained from 30 lung cancer patients, the researchers used single-cell sequencing to map the landscape of gene activity in over 23,000 individual lung cancer cells at three time points: before treatment, after the tumors stabilized or went into remission during treatment, and after the cancer, despite continuous treatment, had fully re-grown and become treatment resistant.

These single-cell profiles revealed the presence of tumor cells that harbored cancer-driving genetic mutations distinct from those that were identified by the various clinical tests that the patients received during the course of their treatment. Though these mutations were present in only a fraction of cells in each tumor, they had a significant effect on patient outcomes. Patients whose tumors carried two or more of these mutations had significantly lower overall survival rates than patients with fewer than two.

The researchers also found that when lung tumors stabilized or went into remission in response to treatment, some malignant cells were able to cling to life by switching on genes associated with injury repair and survival that are normally only active in healthy lung cells. When these genes are active, the cancer cells enter a repair and survival state that, according to Bivona, puts the cells into hibernation mode so that the cell death machinery doesnt get activated.

But these survival genes have an Achilles heel. They rely on whats known as the Wnt/beta-catenin signaling pathway, which can be targeted with existing drugs. In fact, laboratory tests demonstrated that when administered at the appropriate time, drugs targeting the Wnt/beta-catenin pathway, combined with a common lung cancer therapy, reduced the number of cancer cells that survived.

Our results suggest that we could target specific cell states in lung tumors and improve patient survival by constraining tumor evolution and preventing drug resistance and tumor survival and re-growth, Bivona said.

The study also provides key insights into how the cells and tissue that surround a lung malignancy the tumor microenvironment create conditions that prevent the immune system from taking up arms against the tumor.

Single-cell profiling revealed that the tumor microenvironment was hostile to immune activity both before treatment and after a tumor had evolved drug resistance. However, during treatment, when the cancer is in the hibernation mode revealed in the study, the researchers found that immune cells were able to infiltrate the tumor microenvironment and appeared to be switched on, suggesting there may be a limited window of opportunity during which conventional cancer therapies can be combined with immunotherapies a class of cancer treatments that has proven effective against some cancers, but has largely failed against the types of lung tumors profiled in this study to produce better overall survival rates.

Putting tumor heterogeneity front and center would better equip clinicians with information that allows for a high-resolution window into the evolution of tumors during therapy, and help us use such a roadmap to intervene more proactively to better control tumors and help patients, said Bivona. The single-cell analysis that we proved is feasible in real-life clinical tumors may help usher in a new era in the clinical management of tumors during therapy by strengthening our molecular diagnostic toolkit.

Authors: Additional authors include Caroline E. McCoach, Franziska Haderk, D. Lucas Kerr, Elizabeth A. Yu, Philippe Gui, Tasha Lea, Wei Wu, Anatoly Urisman, Kirk Jones, Pallav K. Kolli, Eric Seeley, Yaron Gesthalter, Sourav Bandyopadhyay, Khyati Shah, Lauren Cech, Nicholas J. Thomas, Anshal Gupta, Mayra Gonzalez, Hien Do, Lisa Tan, Bianca Bacaltos, Matthew Gubens, Thierry Jahan, Johannes R. Kratz, David Jablons, Jonathan Weissman, and Collin M. Blakely of UCSF; Ashley Maynard, Lincoln Harris, Weilun Tan, Alexander Zee, Michelle Tan, Rene Sit, Daniel D. Le, Kevin A. Yamauchi, Rafael Gomez-Sjoberg, Norma Neff, and Spyros Darmanis of Chan Zuckerberg Biohub; Julia K. Rotow of Dana-Farber Cancer Institute; and Erin L. Schenk, David M. Naeger and Robert C. Doebele of the University of Colorado.

Funding: This research was supported by NIH awards U54CA224081, R01CA204302, R01CA211052, R01CA231300, R01CA169338, U01CA217882, R01CA227807, T32 HL007185, and K12 CA086913; the Van Auken Foundation; Novartis Pharmaceuticals; Pfizer; the University of California Cancer League; AstraZeneca; The Damon Runyon Cancer Research Foundation award P0528804; Doris Duke Charitable Foundation award P2018110; V Foundation award P0530519l; and the Mildred Scheel postdoctoral fellowship from the German Cancer Aid.

Disclosures: See manuscript for a full list of disclosures.

Link:
Mapping Genetic Diversity of Lung Tumors Over Time May Lead to More Effective Therapies - UCSF News Services

A teenager with autism who was told he was unlikely to ever sit a state exam has been offered a college place to study genetics.

He is determined to find out why his parents - who don't have autism - had four children on the spectrum.

Tristan Lennon from Mornington, Co Meath is getting ready to take his place at University College Dublin (UCD) after securing the extra points he needed through a post leaving certificate course (PLC). The 18-year-old student is encouraging people to take a PLC course, even if they receive the points they need for their preferred course, as he said it gives you the grounding you need for college life.

Tristan's mum Carol was told before his Junior Certificate that it was unlikely that he would ever sit a state exam. She fought to get the additional resources he needed to have the same chance as any other pupil.

"He needed one-on-one help in a lot of subjects so we were told he wasn't expected to sit any state exams due to his needs but I insisted and persisted and, just two days before the Junior Certificate, he was given all he needed as emergency measures," she said.

"And he did really well.

"Again, before the Leaving Certificate, we were told there was no resource accommodation available and again I pulled out all the stops to get it for him."

Tristan, now 18, missed out on the points he needed to get straight into his course but did a PLC, receiving ten distinctions and enough extra merits to get his place in the genetics course in UCD through the CAO round zero.

Tristan was one of 4,411 applicants to receive 5,432 offers for third-level places through the CAO round zero in early August.

Those who fall into the round zero category include graduate entry medicine applicants, additional mature applicants, deferred and access applicants, as well as those presenting QQI FET/FETAC qualifications for courses with a quota for such applicants.

"He has come a long way. We didn't think he would get on the train independently to go to his work experience in Dublin as part of the course but he did and he even stood up to a gang who assaulted him on his first journey," his proud mum said.

Four of Carol's five children have been diagnosed with autism. She has fought hard for extra services for her children over the years.

I've learned that you have to fight and fight hard to be heard when you have a child with autism in Ireland.

"And I'm very proud of where my children are today because of any supports and resources that I've fought for to help them to get the chance they deserve in life."

Tristan has encouraged everyone to consider a PLC course, even if they get the points they need for their preferred couse.

"The PLC gave me a grounding of how college worked and taught me how to commute independently and how to start independently learning," he said.

"Now I'm ready to concentrate solely on my course. My current interest is in genetics and I would like to research if there is a concrete link between the make-up of genes and disabilities.

"I'd love to find out why my parents, who don't have autism, had four out of five children with autism."

More here:
Teen who was told he would never sit an exam prepares to start genetics course at UCD - Irish Examiner

Bronze Age skull in situ in the Tollense Valley. Credit: Stefan Sauer / Tollense Valley Project

The ability for humans to digest milk as adults has altered our dietary habits and societies for centuries. But when and how that ability known as lactase persistence or lactose tolerance occurred and became established is up for debate. By testing the genetic material from the bones of people who died during a Bronze Age battle around 1,200 BC, an international team of scientists including Krishna Veeramah, PhD, of Stony Brook University, suggest that lactase persistence spread throughout Central Europe in only a few thousand years, an extremely fast transformation compared to most evolutionary changes seen in humans. Their findings are published today (September 3, 2020) in Current Biology.

Various bones at a Bronze Age battle excavation site, some of which were genetically tested to determine the presence of the lactase-persistent gene. Credit: Stefan Sauer / Tollense Valley Project

Despite the prominence of milk drinking in Europe and North American today, approximately two-thirds of the worlds population remains lactose intolerant. Generally, no mammal digests milk as an adult, which is why for example people should not give adult cat or dog pets milk. However, a subset of humans have a genetic mutation that enables the enzyme lactase to digest the lactose sugar found in milk throughout an individuals lifetime. Many of these people are from Central or Northern Europe.

The battle occurred on the banks of the Tollense, a river in present-day Germany, and is the most significant that we know about from Bronze Age Europe, probably consisting of about 4,000 warriors, almost a quarter of which died during the fighting. Despite being more than three thousand years old, the researchers were able to sequence DNA from some of the bone fragments recovered from the battle site.

Veeramah, Associate Professor in the Department of Ecology and Evolution in the College of Arts and Sciences, led part of the research that involved analyzing how the overall genetic ancestry of the battlefield population compared to other modern and ancient populations, and then compared the frequency of the lactase-persistent allele to other modern and ancient populations, particularly medieval European populations.

Archaeologists have been systematically searching a section along the Tollense river for more than 10 years. Credit: Stefan Sauer / Tollense Valley Project

The research team, led by Joachim Burger and colleagues at Johannes Gutenberg University Mainz (JGU), found that despite the battle occurring more than 4,000 years after the introduction of agriculture in Europe which in part would have involved the consumption of dairy from early cattle, goats and sheep domesticates only one in eight of the warriors had a genetic variant that enabled them to break down lactose.

When we look at other European genetic data from the early Medieval period less than 2,000 years later, we find that more than 60 percent of individuals had the ability to drink milk as adults, close to what we observe in modern Central European countries, which ranges from 70 to 90 percent said Veeramah. This is actually an incredibly fast rate of change for the gene that controls milk digestion. It appears that by simply possessing this one genetic change, past European individuals with the ability to digest lactose had a six percent greater chance of producing children than those who could not. This is the strongest evidence we have for positive natural selection in humans.

Joachim Burger of JGU, lead author on the study, added that there still is not definitive answer to the question: Why did being able to digest the sugar in milk after infancy provide such a big evolutionary advantage?

With milk being a high-energy, relatively uncontaminated drink, its ingestion may have provided greater chances of survival during food shortages or when supplies of drinking water may have been contaminated, explained Burger.

Reference: Low Prevalence of Lactase Persistence in Bronze Age Europe Indicates Ongoing Strong Selection over the Last 3,000 Years by Joachim Burger, Vivian Link, Jens Blcher, Anna Schulz, Christian Sell, Zo Pochon, Yoan Diekmann, Aleksandra egarac, Zuzana Hofmanov, Laura Winkelbach, Carlos S. Reyna-Blanco, Vanessa Bieker, Jrg Orschiedt, Ute Brinker, Amelie Scheu, Christoph Leuenberger, Thomas S. Bertino, Ruth Bollongino, Gundula Lidke, Sofija Stefanovi, Detlef Jantzen, Elke Kaiser, Thomas Terberger, Mark G. Thomas, Krishna R. Veeramah and Daniel Wegmann, 3 September 2020, Current Biology.DOI: 10.1016/j.cub.2020.08.033

Continue reading here:
Genetic Analysis of Bones From a Bronze Age Battle Reveal Lactose Tolerance Quickly Spread Throughout Europe - SciTechDaily

The University Hospital Heidelberg is one of the major healthcare centers in Germany. Our objective is the development of innovative diagnostics and therapies as well as their quick implementation for the patient. With about 10,700 employees in more than 50 specialized clinical departments with almost 2,000 beds, about 80,000 patients in part-time and full-time inpatient treatment as well as 1,000,000 patients in ambulant treatment are medicated each year.

JobID: P0025V280

Location: Institut of Human Genetics, INF 366, 69120 HeidelbergContract: 2 years with extension possibilities, begin as soon as possibleSalary: Competitive, subject to skills and experience

The newly created Nephrogenetics unit headed by Matias Simons is looking for an enthusiastic postdoc to join our research group at the Institute of Human Genetics of the University Hospital Heidelberg. The general interest of the lab is in the molecular mechanisms underlying hereditary kidney and metabolic diseases. Most of these diseases are caused by single-gene defects and thereby offer unique opportunities to decipher fundamental regulatory pathways of human physiology and to develop targeted diagnostic and therapeutic options. Recent publications include Marchesin et al, Cell Rep 2020; Bedin et al, J Clin Invest 2019; Goncalves et al, PloS Genetics 2018; Simons, JASN 2018; Rujano et al, J Exp Med 2017; Trepiccione et al, JASN 2016; Gleixner et al, Cell Rep 2014. We combine human genetics with several experimental approaches, including fly and mouse genetics, cell culture, microscopy and biochemistry. For more info on the lab see http://www.simons-lab.de.

We offer an exciting project aimed at exploring the role of random monoallelic expression in renal development and homeostasis. For this project, we invite applications from individuals with a solid background in molecular cell biology. Prior experience with stem cells (e.g. mouse ESCs), organoids, single cell RNA-seq, epigenetics and kidney research is an advantage but not a prerequisite. The projects will be carried out in a stimulating work environment with scientific collaborations within the institute, across the Heidelberg life science community (e.g. EMBL, DKFZ) and worldwide.

The successful applicant will have good communication and organisational skills and a PhD in a relevant area (or be in the final stages of completion). We also invite applications from research-oriented MDs. Candidates are expected to be highly motivated and to work independently with a strong work ethic. As we are an international lab, profictiency in English language is a requirement. Applications including a cover letter, a detailed CV including a publication list and contacts of up to three referees should be sent as soon as possible to matias.simons@med.uni-heidelberg.de

The University Hospital Heidelberg offers:

http://www.klinikum.uni-heidelberg.de/karriere

We stand for equal opportunities. People with disabilities are given priority with the same suitability. The university hospital aims at a general increase in the proportion of women in all areas and positions where women are underrepresented. Qualified women are therefore particularly encouraged to apply.

Read more:
ERC-funded postdoctoral position at the Institut of Human Genetics, - Nature.com

The Alliance Review

(NAPSI)Social isolation during the pandemic may pose a mental health threat for those already at risk for COVID-19people over age 65.

As doctors treat more senior patients for depression, an increasingly popular genetic test may inform their treatment decisions. The GeneSight test (www.genesight.com) provides information about how your genes may impact how you metabolize and respond to certain depression medications.

Innovative solutions for mental health conditions are important. As the pandemic and its resulting isolation wears on, many are struggling with their mental health. According to the Centers for Disease Control and Prevention, loneliness can be associated with higher rates of depression.

When I first experienced depression, it happened all of a sudden, shared Doreen, a wife, mother of three grown children, and retiree. It was like a cloud happened in my head.

Symptoms of depression can include changes in sleep or eating patterns, decreased energy, difficulty concentrating or a lack of motivation.

Doreen saw her doctor, who prescribed a depression medication but it didnt alleviate her symptoms.

I began to see one doctor, then another, to help deal with my depression, said Doreen. Her doctors tried many, many different medications and none seemed to work. Finally, my heart doctor said, Doreen, Ive heard about this gene test, I think it might help you.

Her doctor was referring to the GeneSight test.

The test is a simple cheek swab, ordered by a healthcare provider who can prescribe medications. A patient can take the test at home or in the doctors office.

Using a patients unique DNA, the GeneSight test informs doctors about potential gene-drug interactions. The report provides information about which depression medications may require dose adjustments, may be less likely to work, or may have an increased risk of side effects based on a patients genetic makeup.

The GeneSight test helped Doreens doctor to make an informed treatment decision; she was prescribed a new medication.

Thats when my life started to change. I got back to smiling, being happy and laughing again. I got back to being me, Doreen said.

Post-pandemic life will likely never be the same. If depression is one of the unanticipated consequences, treatment is important.

People struggling with depression can ask their doctor about the GeneSight test. To learn more, visit http://www.GeneSight.com.

Read the rest here:
Pandemic Depression: Genetic Insight May Help Treatment - The-review

The consumer genetics startup, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

A Boston consumer genetics company that has batted away former employees accusations of shoddy practices since at least 2019 is now under investigation by the state Department of Public Health for logging hundreds of false positive coronavirus test results.

The company, Orig3n, has halted COVID-19 testing in the state. A company spokesman said the false positives were due to "human error" in processing the tests.

In August, after learning about the Massachusetts investigation, North Carolina issued a stop order for its coronavirus testing contract with Orig3n.

The consumer genetics startup, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

So far, the Massachusetts DPH has found Orig3n sent out more than 300 COVID-19 tests wrongly classified as positive in Massachusetts, a number that could increase as DPH staff continue investigating. Orig3n claims the company isnt aware of any additional false positives. According to a Harvard epidemiologist and lab director, false negatives are far more difficult to discover, because most tests come back as negative.

Ted Owens, CEO at North Hills Pines Edge skilled nursing facility in Needham, one of roughly 60 long-term care facilities that used Orig3n test services, said in an Aug. 11 bulletin to residents and staff that Orig3n returned a total of 19 false positives to the nursing home.

The numbers didnt seem credible to Owens, but Pines Edge began immediately to take actions based on the working assumption that we needed to treat these results as correct.

It turned out that several other skilled nursing facilities also showed an unusual spike in positive cases last week, and oddly enough, all these facilities had used the same testing vendor, Owens continued. This caught the attention of the epidemiologists at Mass DPH, who intervened and instructed the vendor to re-test the samples."

Upon retesting, all of the positive tests were found to be negative.

The spike in cases which turned out to be false positives caused panic in Needham. They came as the school district made plans to return to in-person learning, and a public health nurse for the town was asked to appear before the Select Board.

Needham public health nurse Tiffany Zike told the board on Aug. 18 that a number of coronavirus cases reported in July were considered false cases that were revoked due to the lab having an issue.

$25,000 wire transfer

In early May, nursing homes throughout Massachusetts were looking for a miracle.

The DPH had ordered long-term care facilities coping with severe coronavirus outbreaks to test 90% of residents and staff for COVID-19 by May 25 in order to qualify for a portion of $130 million in relief funding offered by the state.

Many nursing homes struggled to meet the deadline because of a shortage of COVID-19 tests. The National Guard was testing nursing home residents and staff on behalf of the state, but demand was high.

When Ron Doty got a memo from the Massachusetts Senior Care Association on May 6 offering Orig3n as a turnkey mobile testing option, he immediately reached out to the company.

Doty, administrator at Marlborough Hills Rehabilitation & Health Care Center in Marlborough, wired $25,000 to Orig3n. The next day, he received 250 COVID-19 test kits from the company.

Two months later, Orig3n was asked to suspend COVID-19 testing in Massachusetts, which it did on Aug. 8. Staff at the DPH noticed the lab was reporting an unusually high rate of positive tests, prompting the agency to investigate, according to a DPH spokesperson.

The state DPH declined to identify which nursing homes used Orig3ns testing services, citing the ongoing investigation.

Tony Plohoros, Orig3ns spokesman, said the lab is now working with state health officials to correct problems in its Boston lab, which has ceased processing coronavirus samples but continues to process consumer genetic profiles.

While it remains unclear if the federal government has taken action to halt use of Orig3ns COVID-19 testing services in other parts of the country, as North Carolina did, concerns about Orig3n hadnt yet reached a health care supply company in Ohio as of this week. That company, Mason, Ohio-based Link-age Solutions, is still working with Orig3n to provide coronavirus tests to long-term care facilities nationwide.

Patrick Schwartz, a spokesman for Link-age Solutions, said Thursday that the company was unaware Orig3n was asked to cease coronavirus testing in Massachusetts.

One of the highest accuracy ratings in the market

Orig3n received an emergency authorization to conduct COVID-19 testing from the Food and Drug Administration in April.

The same month, the company received a federal Paycheck Protection Program loan valued between $350,000 and $1 million from Silicon Valley Bank, according to U.S. Treasury data.

Since getting the FDA approval, Orig3n has provided testing services to The New England Power Generators Association, Bostons homeless population, a boarding school in Virginia and other public and private entities.

In late June, Link-age Solutions, which helps long-term care facilities nationwide obtain supplies ranging from pharmaceuticals to office supplies, issued a press release touting Orig3ns breakthrough testing method as having one of the highest accuracy ratings in the market.

In partnering with Orig3n, Link-age could offer in-demand coronavirus tests to its members at a reduced cost, according to the press release. Results would be returned less than 36 hours after specimens arrived at the lab, the release said.

The lab boasts output capabilities of 6,000 and up to 12,000 tests per day, and will offer billing to Medicare where appropriate, the press release stated. Reporters questions to the Centers for Medicare & Medicaid Services have gone unanswered.

Schwartz, the Link-age spokeman, said Thursday his company continues to offer COVID-19 testing services performed by Orig3n, and that feedback about Orig3ns tests from its customers has been positive.

Company flagged in the past

Orig3n lists its office location as the third floor of 27 Drydock Ave. in the heart of Bostons Seaport neighborhood. Until August, thats where the company processed its coronavirus tests.

Before it got into the coronavirus business, Orig3n billed itself as a consumer genetics pioneer, carving a path toward a future of wellness and health through the use of diagnostics, genetics and biotechnology.

The company, founded in 2014, offers tests ranging in cost from $29 to $298 that are supposed to help people learn what kinds of food, exercise and beauty products would work best for their genetic profiles, and even whether they are genetically predisposed to so-called superhero traits including intelligence and strength, according to Bloomberg Businessweek.

A former Orig3n employee who spoke to Gannett New England reporters on the condition of anonymity because of a nondisclosure agreement with the company said the number one complaint received by customer service was genetic profile tests not being returned to customers. The employee, who left the company pre-pandemic, didnt think the company could handle both genetic profile testing and coronavirus testing.

Unless things drastically changed since I have left, not even testing, just bandwidth-wise, they were already kind of drowning when I left, the employee said.

Despite its startup status, Orig3n quickly gained prominence partly through securing big-name partnerships, including one with the NFLs Baltimore Ravens.

In September 2017, the Ravens linked up with Orig3n for an event called DNA Day. Roughly 70,000 Ravens fans were set to pour into the teams stadium, where they could have picked up a free genetic testing kit.

The event never happened. The Ravens postponed it days before federal health officials told The Baltimore Sun they were working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988.

The federal regulatory standards apply to labs testing human samples in the United States, and are intended to ensure accuracy, effectiveness and reliability.

About a year after DNA Day was scrapped, 17 former Orig3n employees criticized the company in Bloomberg Businessweek, alleging it habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards.

Marketing, not science, the employees said, was the companys priority.

Press releases put out by Orig3n throughout the pandemic show the company was eager to publicize contracts with respected institutions, both public and private.

On May 12, the company announced what it called a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.

In the press release, the company said it sought to become the partner of choice for coordinating and providing COVID-19 testing for defined populations beyond long-term care residents and employees, including private employers, schools, government agencies, and cities and states.

The nursing home program is one of many applications for Orig3ns fully-integrated solution, the press release said.

What went wrong?

Doty, the Marlborough nursing home administrator, would not have known about Orig3n if not for the May 6 memo from Massachusetts Senior Care Association, an organization many nursing homes relied on during the viruss spring surge in the state to interpret complex and shifting guidance from the DPH.

Massachusetts Senior Care Association President Tara Gregorio said in a statement that her organization essentially serves as a messenger for its members, and that it relies on governmental agencies to vet labs like Orig3n.

"Throughout the pandemic, MSCA has passed along lists of government approved COVID-19 PCR testing labs options available to our members, Gregorio wrote. We must rely, as all providers do, on the licensing process to ensure legitimacy and accuracy of these labs."

The FDA, which gave Orig3n emergency authorization to conduct coronavirus testing last spring, has not yet responded to Gannett New England reporters seeking comment.

According to a Massachusetts DPH spokesman, Orig3n told the agency after it was contacted by DPH that errors in testing occurred because of a broken vial or contaminated plate during final processing, an explanation DPH investigators are now trying to confirm.

In an email to Gannett New England reporters on Friday, Plohoros, Orig3ns spokesman, said human error at the beginning of the laboratory testing process caused a pre-extraction reagent that was used in the affected batch tests to become contaminated.

In an Aug. 18 press conference, Massachusetts Secretary of Health and Human Services Marylou Sudders said erroneous results from Orig3n affected the number of COVID-19 cases reported in Fall River and Taunton.

The positive test rates for that three-day period for that one lab just seemed high, and so (we) went back, and the lab stopped processing, they're still not processing any tests, Sudders said, adding that DPH staff was analyzing tests processed prior to the discovery to make sure the issue was, as Orig3n told the DPH, a one-time problem rather than a more structural issue.

Dr. Michael Mina is an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories that perform PCR testing.

Mina says a lab that processes 6,000 to 12,000 PCR coronavirus tests a day as Orig3n has said it does would need to be run with what he called extreme quality control measures.

It requires an amazing amount of concentration and care to really ensure you're not getting contamination or any number of other problems that can happen, he said. If this was an easy (test), I would have said, sure, any lab can do it but this particular (test) ... it really is a finicky test. You have to be extremely careful about how you're doing it, and that means you need a lot of quality controls. You need to be a really diligent lab.

Mina, who stressed he has no knowledge of Orig3n other than circulating allegations that the company had previously been investigated, said when a mistake like the kind Orig3n described occurs, staff should immediately stop processing, sterilize the area and alert any affected patients and health departments.

The fact that the Massachusetts DPH noticed the problem and not Orig3n is a problem, Mina said.

That shows in general that the quality control wasn't being maintained, he said, adding that performing intense quality control checks multiple times daily is a core tenet of running any lab, especially a high-complexity clinical lab. And if we're giving them the benefit of the doubt, they didn't know that there was a problem because otherwise it's just nefarious.

Mina said that a professionally run lab would likely have caught the mistake, and alerted the state DPH immediately.

Part of the reason for that is simply a motive to care for the patient, who will likely make important decisions about their own behavior based on the test result they receive, which in turn affect other people.

At Brigham, for example, where I was one of the medical directors, of course people feel embarrassed (about making a mistake), but there's this strong culture where people recognize that their embarrassment is not worth a patient's hardship, Mina said. That's one thing that really, I think, lacks a little bit when we move into industry laboratories running clinical tests. That same spirit of honesty ... might not exist everywhere.

While mistakes at labs are common, Mina said, they're also commonly fixed and they don't usually require an investigation.

Mina said that the U.S. did need to increase its capacity to process coronavirus tests this spring, but labs, especially ones new to the medical diagnostics space, as Orig3n is, need to be monitored closely.

It's just important to keep all these things in check, Mina said. The frenzy to do coronavirus testing has been so extreme. I don't think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.

Trevor Ballantyne and Jeannette Hinkle are reporters for Gannett New England.

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Massachusetts startups COVID-19 testing halted as hundreds of false results probed - Enterprise News

Global Genetic Ancestry Testing Market Report from AMA Research highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.

Major Players in This Report Include,

MyHeritage (Israel), Laboratory Corporation (United States), Myriad Genetics, Inc. (United States), Ancestry.com LLC (United States), Quest Diagnostics (United States), Gene By Gene (United States), DNA Diagnostics Center, Inc. (United States), Invitae (United States), IntelliGenetics (United States) and Ambry Genetics Corp. (United States)

Free Sample Report + All Related Graphs & Charts @: https://www.advancemarketanalytics.com/sample-report/125027-global-genetic-ancestry-testing-market

Definition

Genetic ancestry testing is a way for people interested in family history to go beyond what they can learn from relatives or from historical documentation. It gives clues about where a persons ancestors might have come from and about relationships between families.

Global Genetic Ancestry Testing Market Report offers a detailed overview of this market and discusses the dominant factors affecting the growth of the market. The impact of Porters five armies on the market over the next few years has been discussed for a long time in this study. We will also forecast global market size and market outlook over the next few years.

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The Genetic Ancestry Testing market study is being classified by Type, Applicationsand major geographies with country level break-up that includes South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).

The Global Genetic Ancestry Testing is segmented by following Product Types:

by Type (Y Chromosome Testing, Mitochondrial DNA Testing, Single Nucleotide Polymorphism Testing), Service (Online Testing, Offline Testing)

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Current Scenario Analysis for Decision Framework

Key Strategic Developments in Genetic Ancestry Testing Market:

The research includes the key strategic activities such as Research & Development (R&D) initiatives, Merger & Acquisition (M&A) completed, agreements, new launches, collaborations, partnerships & (JV) Joint ventures, and regional growth of the key competitors operating in the market at global and regional scale to overcome current slowdown due to COVID-19.

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The report highlights Genetic Ancestry Testing market features, including revenue size, weighted average regional price, capacity utilization rate, production rate, gross margins, consumption, import & export, demand & supply, cost bench-marking in Genetic Ancestry Testing market share and annualized growth rate (Y-o-Y) and Periodic CAGR.

Extracts from Table of Contents

Global Genetic Ancestry Testing Market Research Report

Chapter 1 Global Genetic Ancestry Testing Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Revenue (Value, Volume*) by Region

Chapter 5 Global Supplies (Production), Consumption, Export, Import by Regions

Chapter 6 Global Revenue (Value, Volume*), Price* Trend by Type

Chapter 7 Global Market Analysis by Application

.continued

This report also analyzes the regulatory framework of the Global Markets Genetic Ancestry Testing Market Report to inform stakeholders about the various norms, regulations, this can have an impact. It also collects in-depth information from the detailed primary and secondary research techniques analyzed using the most efficient analysis tools. Based on the statistics gained from this systematic study, market research provides estimates for market participants and readers.

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Genetic Ancestry Testing Market is expected to double its Market Size in Upcoming Years - Scientect

Written by Parthasarathi Biswas | Pune | September 3, 2020 11:14:01 pmTo encourage farmers, the programme marketed the produce under the brand, Farming Monk, in urban areas for a premium. (Representational)

SIX YEARS after they took up the work of conserving local or traditional (better known as landrace) varieties of rice, sorghum and vegetables, Pune-headquartered BAIF Development and Research Foundation (BDRF) now has plans to take their work to a molecular level. Along with National Institute for Abiotic Stress Management in Baramati, BDRF will try to identify genetic traits that allow these varieties to develop better climate resilience than more commonly grown commercial varieties.

Since January 2014, BDRF has started Maharashtra Gene Bank Programme for Conservation, Management and Revival of Local Resources.

Under the sponsorship of Rajiv Gandhi Science & Technology Commission of the state government, this project has been involved in preserving landrace varieties of crops like rice, millet, sorghum, maize, hyacinth bean, cowpea as well as indigenous livestock varieties for the past six years.

Vitthal Kauthale, thematic programme executive, BDRF, said the project saw both in situ (on spot) and ex situ conservation of landrace varieties. The project, which is to end by September 30, has so far seen conservation of 350 varieties of different crops in 25 in situ conservation at six clusters.

Kauthale said landraces, at present, are under threat with farmers opting for more commonly available commercial varieties. In fact, some of the rice varieties that the programme managed to salvage from near extinction, were now found only in tribal regions of Maharashtra, he said.

He also said these land varieties had better climate resilience than commercial varieties and could withstand heavy rainfall and other extreme climatic events.

During the last six years of the project, BDRF partnered with the local community for preserving local varieties. The process involves purification, trait identification, and then propagation of the variety at the farmer level. Last year, the project recorded production of 13.2 tonnes of worthy landraces of six focused races and availability of quality seeds through village-level community seed banks at six clusters and one central seed bank.

The project has involved self-help groups conserve and propagate crops. To encourage farmers, the programme marketed the produce under the brand, Farming Monk, in urban areas for a premium.

As the project comes to an end, BDRF has plans to upscale the project in a more scientific manner. To date, we were protecting and preserving landraces on field. Now, we wish to go to the molecular level and try to identify genetics that provide resilience to these varieties, Kauthale said.

He added that the collaboration with the Baramati institute aimed at doing the same, and once this was identified, the genes could be used to impart the same characteristic to commercial crops.

One of the major problems faced in conservation of landraces is the lack of any legal identity. The Seed Act, which governs the business of seeds, does not mention landraces and, thus, such seeds cannot be sold commercially. The BDRF has plans to take up policy-level intervention to allow the seeds to be traded.

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BDRF, Baramati institute to identify genetic traits of landrace varieties of crops - The Indian Express

While genetics can play a significant role, the picture is much bigger.

If a man has type 1 diabetes, there is a 1 in 17 chance that his child may also get it. The oddsreduceto 1 in 25 if the woman has it, and the child is born before she is 25. Type 2 diabetes has astronger linkto genetics than type 1. Genes also playsome rolein conditions like hypertension and heart ailments. And just like these illnesses, mental health issues also have some degree of heritability. However, the stigma associated with mental health makes the heredity and its implications more difficult to navigate.

Recently, actor Rhea Chakraborty said in an interview that late actor Sushant Singh Rajputs mother had lived with depression. Sushant, who was found dead in his Mumbai apartment in June, reportedly by suicide, was living with mental health issues as well. In the aftermath of the incident, there have been discussions on how Sushants mental health struggles could have been hereditary. But what do we really know about the link between genes and psychiatric disorders?

There have been numerous studies in the past and ongoing to study these links. Astudyby Consortium on the Genetics of Schizophreniapinned the heredity of schizophrenia at 31% to 44% in nuclear and extended families respectively. When bipolar disorder was included in this, the heritability increased to 37% in nuclear families. And when it came to depression, in the same study, the heritability dropped to 34% in nuclear families and 20% in extended families.

Otherstudiessay that the chances of a person developing schizophrenia if a biological parent has the condition are 13 in 100, and for bipolar disorder, its around 30 in 100. Studies have also been done on identical twins, and have found that if one sibling has schizophrenia, theres a 40-50% chance the other will develop it, because they share the same genetic makeup. Alzheimers dementia is another disease known forhigh heritability.

Dr Sanjeev Jain, officer-in-charge of the Molecular Genetics laboratory and a professor of Psychiatry at the National Institute of Mental Health Sciences, (NIMHANS) in Bengaluru, points out that most things including looks are inherited from biological parents. Mental illness is not very different that way. The only thing is that we have not been able to figure out the precise mechanism by which the causal genes get triggered. Besides, people tend to forget that if there is a 10% chance you will develop a mental health condition due to heredity, there is also a 90% chance that you wont. Till date, we have not been able to predict mental illness, because it does not only depend on the genes, he says.

Dr Sanjeev has been involved in many research and molecular diagnostics projects on neuropsychiatric disorders including Obsessive Compulsive Disorder (OCD), alcoholism, dementia and schizophrenia for several years. He, along with his colleague, Dr Biju Viswanath, Associate Professor of Psychiatry at NIMHANS, are conducting a study Accelerator program for Discovery in Brain disorders using Stem cells(ADBS) using clinicalinvestigations, modern human genetics, and stem cell technology" at NIMHANS. The study has been on since 2016.

Dr Biju says that while there's a 60-70% risk of developing a psychiatric illness contributedby genes, there are several other factors that cannot be discounted. Dr Hema Tharoor, a psychiatrist associated with Chennai-based Schizophrenia Research Foundation (SCARF), points out that it is ultimately the gene-environment interaction that determines whether a person could develop a mental health issue.

There are studies, for instance, that look at siblings wherein one parent had schizophrenia but only one child developed it, and the other two did not. And its not just sociologicalfactors that playa major role in determining ones mental health, it is also things like the antenatal and postnatal care of the mother, low birth weight, infections during pregnancy, that determine the risk of developing these disorders in the persons life too, she explains.

One 2011study, for instance, found that the risk for schizophrenia increased with certain obstetric complications, famines, migrant status, and advanced paternal age. Severe pregnancy and perinatal complications also accounted for environmental risks.

Further, Dr Sanjeev points out, its very difficult to separate genetics and culture. At any point of time, you are expressing only a third of your genes. Different genes will express themselves at different points of time. Only when that expression crosses a threshold does it become a disease.

Besides, we simply dont know all the genes that contribute to the risk of developing a psychiatric disorder or illness. In the case of Alzheimers, studies haveimplicated215 potential causative genes. However, the study by the Psychiatric Genomics Consortium said that these only explain a small proportion of genetic variance, meaning that yet undiscovered genes remain. This is the case with other mental health issues and psychiatric disorders as well.

Even so, experts say it is not necessary that everyone who carries the risk increasing genes will develop the illness its just that the genes could increase the susceptibility of an individual to getting it, and the trigger threshold for the onset could be lower. So, for instance, if someone is at a higher risk to develop OCD due to heredity, and they have also been through trauma in childhood, it could cause early onset. But its also possible that they do not develop it at all, depending on the other factors, Dr Biju says.

Several illnesses like breast cancer and leukaemia have been proven to have a high heredity factor. In some cases, gene therapies have been devised to correct or replace certain genes that could cause some illnesses. However, this is not the case with mental illnesses. The study of the brain and mind is harder because you cant just do a biopsy of the brain, says Dr Sanjeev. However, the advantage to figuring out the genomic links to mental health is that once we know the cause, we can have better drugs to treat them. Most of the ones we use now are decades old.

Dr Biju similarly says, As a doctor, you want to see your patients health improve. Say, 50% of the patients get better with psychiatric medication, but the remaining struggle. But we do not know why the medication is not working. So, if we can understand how the illness or disorder originates by identifying the genes, you can identify the mechanisms; and then we can move to more effectivetreatments.

Dr Abhishek ML, a psychiatrist and a research faculty at Bengaluru-based Indian Institute of Science (IISc), says that another hope in studying the heredity of mental health issues is early preventability. Dr Hema adds, If we can establish the endophenotypes (the neurobehavioral traits that quantify genetic susceptibility to developing a psychiatric disorder), then it becomes a preventable risk. Special care can be taken then in, say, antenatal or postnatal care.

However, Dr Abhishek cautions that this sort of technology should be accompanied by destigmatising mental health, lest it leads to profiling of persons living with certain mental health conditions and impinging of their rights.

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Understanding mental health and its heredity: What experts know so far - The News Minute

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Four aging dams on the Klamath River are coming down. Their completion between 1921 and 1964 brought hydroelectric power to Northern California. It also blocked hundreds of kilometers of fish habitat, causing chinook salmon to effectively disappear from the upper river basin. But the removal of dams is no guarantee the fish will return, so a team of wildlife researchers hopes it can coax the fish to repopulate the river by exploiting a new discovery about salmon genetics.

The Klamath was once the third-largest salmon-producing river in the United States, and its fish are still prized by Indigenous tribes that live along its winding path. In the Klamath, as in many other rivers, chinook salmon come in two main types: spring-run and fall-run. Spring-run fish start their migration from the rivers estuary four to six months before their fall-run cousins, and their return spawning run takes them farther up the river. Over time, however, human activities including mining, agriculture, and dam construction all but swept spring-run fish from the upper Klamath. Today, only the fall run of chinook salmon is large enough to support fishing.

Though dam removal has yet to beginthat wont come for at least another yearJohn Carlos Garza and Anne Beulke are already investigating how to replenish spring-run chinook in the upper reaches of the Klamath River Basin. Garza is a geneticist with the US National Oceanic and Atmospheric Administrations Southwest Fisheries Science Center and a researcher at the University of California, Santa Cruz, where Beulke is pursuing doctoral studies. Their research was motivated by a mystery of salmon behavior.

People have long recognized spring- and fall-run patterns, but scientists couldnt actually explain what caused this distinction. We found these curious patterns again and again, Garza says, even though they were the same type of salmon. Once they acquired the technology to quickly sequence fish DNA, however, the scientists started analyzing the genes of salmon that spawned at different times. We found a single region in the genome thats responsible for the difference between early- and late-migrating fish, Garza says. This led them to wonder whether they could re-create the missing spring-run salmon by crossing fall-run salmon with those that have the early-migration gene.

Garza and Beulke are now preparing to apply their discovery. They plan to crossbreed and release hatchery-raised spring-run chinook from the nearby Trinity River with fall-run chinook from the Klamath. When the fish return to the hatchery once more to spawn, theyll crossbreed them again with more fish from the Klamath. With every generation, youll get fish with a higher percentage of their ancestry from the Klamath River, he says.

Ideally, Garza and Beulke should begin their project this September to take advantage of the 2020 spawning season. Their work was scheduled to start in March, but stakeholder agencies have been slow to agree. The current pandemic may influence their schedule, too. I cant even get into the lab right now, Beulke says.

Although other plans have proposed reintroducing spring-run fish from nearby rivers, Garzas method has the advantage of preserving the evolutionary history of the Klamath River fish. During his analyses, Garza noticed that some fall-run salmon included genetic descendants of the Klamaths earlier spring-run fish. Crossing spring- and fall-run fish from within the river, then, would enable new spring-run generations to also preserve the adaptive genetic patterns of their Klamath ancestors.

At this point, I like Carloss approach, says Kathleen OMalley, a geneticist at Oregon State University. Its a great opportunity to test the connections between a genomic region and run timing. There are a lot of variables, she adds, but its certainly a worthwhile project. It may take more years than anticipated, though, to actually get enough data points.

Garza is comfortable taking the long view. This is a process that occurs naturally, he says. Were just accelerating things. Within 10 years, we could have thriving spring-run chinook salmon populations.

After all, the dams have been up for 100 years.

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Coming Home to the Klamath - Hakai Magazine

CHICAGO--(BUSINESS WIRE)--Please replace the release with the following corrected version due to multiple revisions.

The updated release reads:

BASE10 AND DNA LINK COVID-19 ANTIBODY TEST YIELDS PROMISING RESULTS

DNA Links Serology Test Showed High Degree of Sensitivity and Specificity for Detecting COVID-19 IgG Antibodies

BASE10 Genetics, Inc. (BASE10) announced the results of an independent study that showed 95% sensitivity and 100% specificity for SARS-Co-V-2 IgG antibodies using AccuFind COVID19 IgG test by DNA Link, Inc. The study was performed at John Hopkins University.

BASE10 offers a COVID-19 Tracking and Recovery Program that assists employers in launching testing and monitoring strategies for COVID-19. The company has been working to incorporate antibody testing to track the full life cycle of SAR-Co-V-2.

Having a reliable COVID-19 antibody test solution is important to our clients in understanding how the virus has affected their specific population. Our team and DNA Link have worked hard these past months to reach this important milestone, says Dr. Michael Fang, BASE10 CEO.

The two companies now plan additional studies with a selected number of BASE10 clients to further meet regulatory compliance and improve clinical usability. We want to work very closely with regulatory bodies in everything we do, while making sure good tests are available to patients and their providers at the right place and time, says Elizabeth Freund, BASE10s VP of Innovation.

Solid science is a valuable commodity in these times of uncertainty, and we are committed to provide the scientific rigor of AccuFind COVID19 IgG to the world, says Dr. Jong-Eun Lee, CEO of DNA Link. We look forward to continuing to gain traction with BASE10 on this important mission.

_____________________

About BASE10 Genetics, Inc.

BASE10 is a precision medicine company based in Chicago. BASE10s proprietary platform identifies precision diagnostics technologies with high potential for improving health outcomes, and creates turnkey disease management solutions to be deployed at scale for insurance payors.

Media inquiries: media@base10genetics.com

About DNA Link, Inc.

Established in 2000, DNA Link is a genomics company based in Korea. The company produces high-quality genomic data through up-to-date technologies, discovers biomarkers for molecular diagnostics and precision medicine. DNA Link strives to lead personalized medicine and new drug target identification.

Media inquiries: ikjun.choi1@gmail.com +82-10-6291-6180

Continued here:
CORRECTING and REPLACING BASE10 and DNA Link COVID-19 Antibody Test Yields Promising Results - Business Wire

Cranial cruciate ligament rupture (CCLR) is a leading cause of pelvic limb lameness in dogs. About 6% of Labs suffer from this orthopedic problem and since this breed is one of the most popular in the U.S.,Michael Conzemius, DVM, PhD, DACVS, andMolly McCue, DVM, MS, PhD, DACVIM, with the University of MinnesotaCollege of Veterinary Medicinedecided to collaborate on a study to determine the diseases heritability in Labrador Retrievers and they wanted to measure the extent to which CCLR is associated with genetics in this breed.

Cruciate ligaments, connecting the femur to the tibia bones, are called cranial and caudal in quadrupeds, such a dogs; the cranial cruciate ligament (CCL) is analogous to the anterior cruciate ligament (ACL) in humans. These ligaments are prone to rupture, in humans, dogs, horses and, in other species.

Previous work has shown that approximately 2.5% of dogs are affected with at least one CCLR, and various factors including breed, sex, age and sterilization statusincluding age at sterilizationhave some effect on the likelihood of experiencing a CCLR(Witsberger et al. 2008; Simpson et al. 2019).

While this condition is mainly found in large and giant breeds of dogs, it has been noted that it has a low incident rate in Greyhoundsa large-sized breedso this has lead researchers to theorize that there is a genetic influence to the occurrence of CCLR.

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The researchers explained that, interestingly, in most cases with dogs, CCLR isnt a contact injury or due to acute trauma. This has led to various causal theories: degenerative processes may be occurring within the ligament; there exists an inability to repair damaged tissue at a typical rate; or defects exist within the dogs general conformation (Buote et al. 2009; Muir et al. 2011).

The methodology of this study has proven effective in horses, and this was the first study to use these techniques to estimate heritability in dogs with CCLR. The scientists found relatively high heritability for CCLR in Labrador Retrievers, which indicates that genetics contribute substantially to the diseases prevalence in the breed.

These findings should help get clinicians one step closer to a genetic test for earlier diagnosis and treatment. However, heritability estimates do not pinpoint the genes involved, so the scientists say future studies should focus on determining which genetic mutations specifically increase the risk for CCLR in this breed.

As Michael Conzemius, the studys co-author noted, This is an extension of research that we began nearly 20 years ago in an effort to establish the role of genetics in this disease that is exceptionally common in some breeds of dogs. Our long-term goal has always been identifying mechanisms to decrease the frequency of cranial cruciate ligament disease. We plan to continue this work and hopefully it will contribute to a functional genetic test.

This research was funded by the National Institutes of Health (K01OD027051), Veterinary Orthopedic Society, Tata Group Endowment at the University of Minnesota, and the Bernice Barbour Foundation.

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The Importance of Genetics in Leading Orthopedic Problem in Dogs - The Bark

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A major breakthrough in treating a genetic disorder can be credited to our next guest. Sickle cell disease is a blood disorder that affects more than 20 million people worldwide. Theyve recently had a breakthrough. Federal News Networks Eric White spoke to one of the scientists at the National Institutes of Health conducting research on sickle cell on Federal Drive with Tom Temin. Dr. John Tisdale is a finalist in this years Service to America Medals program.

Dr. John Tisdale: I trained in internal medicine, and that was in the early 90s. I encountered patients with sickle cell disease who were experiencing extraordinary pain. And at that time, all we had was pain medication. So we would give pain medication and IV fluids because very often dehydration was what provoked the pain episode in these patients. But we had no specific treatments, nothing that were directed at the disease itself, only management of the pain. It was strange to me because I had learned about sickle cell disease in genetics classes and had known that we knew the basis for this disease longer than any other disease, yet we had no treatment, nothing. So it motivated me to think about ways that could treat the disease. The obvious thing that came to mind was a bone marrow transplant because we had a very active bone marrow transplant service at Vanderbilt. And I found that a very exciting way to approach disease and it just made sense that if you have a blood disease that causes all this difficulty in blood comes from the bone marrow well one obvious way to fix it is just to replace the bone marrow with one that doesnt have the genetics that causes the disease, like a brother or sister that we were doing for other kinds of diseases, and that could potentially cure the disease. And in fact, I learned that it had been done before in a patient who had leukemia. And that was a reason for her getting a bone marrow transplant. But she also had sickle cell disease and she was cured of both. There were some efforts during that time to bring that to the clinic, in the pediatric setting, and everything is always easier with kids because theyre tougher when it comes to medications and transplants and all the things that you can think of doing, chemotherapy. That got me motivated into studying hematology and bone marrow transplant, and trying to figure out ways to bring bone marrow transplant to patients with sickle cell disease.

Eric White: This sickle cell disease, obviously weve all heard of it. Even if you know what it is, its still a complicated disease. Can you explain what is the latest research says that sickle cell disease actually does over? As I said its a very strange disease that affects the body in many different ways. Are there any new findings as to how it does actually affect it?

Dr. John Tisdale: Well, I think weve known for a very long time exactly what happens in this disease. It arose as a way to protect from death from malaria. So just one little letter off for the gene that makes our hemoglobin, and hemoglobin is the molecule in red blood cells that carries oxygen around the blood. So one letter off in part of that molecule, and you have protection from malaria, you dont get the very severe form of malaria because the red cell is not as hospitable to the parasite. So that gets selected for in areas where theres malaria, like in Sub Saharan Africa. But if you get two copies of the gene, one from mom and one from dad, you get this disease, sickle cell disease because the hemoglobin now is different than the normal hemoglobin. Instead of carrying oxygen around and staying in solution like it does normally, you have a hemoglobin that once it does its job by dropping off oxygen out in the body, it can come out of solution and become like rock hard, distort the shape of the red cell thats normally squeezing through blood vessels to find its way back to the lungs to get more oxygen. When that happens, block the circulation. So it kind of causes a log jam and all the blood behind it gets stuck. And so wherever that happens, gets starved of its oxygen. So I mean, if it happens in the brain, for example, it causes a stroke. And so kids, eight years old can have a stroke that looks exactly like the sort that we see in the elderly who have vascular disease. If it happens in the muscle, its extremely painful or in the bone. And it happens in every organ in the body. And as a result can damage those organs over time and significantly shorten the lifespan of patients with sickle cell disease. So the lifespan currently is in the 40s. And thats much improved over the last several decades, but its still much lower than then people without the disease.

Eric White: So with your research, what has given you the most promise? What results have you all hung on to whether its bone marrow transplant or gene therapy? Is there one that you say hey, we might be on to something here?

Dr. John Tisdale: Well, I think the biggest breakthrough that weve made is figuring out just how much of the bone marrow we have to fix. So it turns out, we dont have to completely replace the bone marrow with somebody elses bone marrow to make the blood normal. So normally in a bone marrow transplant you you have to give chemotherapy to take away all of the cells that are making blood. Thats kind of like tilling the garden, right? You cant go out in the middle of a cornfield and spread a bunch of tomato seeds and expect to have tomatoes there, theyre not going to grow because the corns already growing. So the thinking is to do a bone marrow transplant, you have to harvest the corn, till the soil, plant the sees. And the same is true for bone marrow transplants. But it turns out for sickle cell disease, we dont have to do that. Weve had patients who even though we try to get rid of all their bone marrow, we failed and they had up to 80% of their own bone marrow still making blood, and presumably sickle blood. But if we had only 20% from the donor that was making normal blood, that would result in all of the blood being normal. And thats just because sickle cells live 10 or 12 days in the circulation, normal cells live 120 days in the circulation. And since the normal cells have such an advantage, you dont really have to completely eradicate the patients own bone marrow or you dont have to fix every cell. So thats important. That told us two things. One, we dont have to use toxic chemotherapy that we normally have to use to do a bone marrow transplant. And furthermore, we can start to think about gene therapy as an approach because we know we can never fix every cell. But if we could fix 20% of cells, we would predict from what weve observed in patients getting transplants from their brother or sister, that wed be able to fix the disease. And were well above the 20% mark when we transfer genes into cells. We can also correct the mutation at higher than 20%. So knowing that we only have to get to 20% has allowed us to start clinical trials, using the patients own bone marrow where we take those seeds out and try to fix them and give them back. If we can make 20%, we think we can fix the disease.

Eric White: Is there anything else that youd like to get the word out on? Is there any way people might be able to help or if if they have any family members who are suffering from this, if theres anything you would like to tell them?

Dr. John Tisdale: Well, I mean, I think the thing thats very important to understand for anyone with a genetic disease or otherwise is that clinical trials are the way that we make progress. And so participating in clinical trials is important for moving the field forward, and we partner with our patients and their family and their support structure to do these clinical trials and to make progress in the disease. So its extraordinarily important for people to understand that. Thats the way we make progress.

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NIH scientists credited with breakthrough in treating a genetic disorder - Federal News Network

On the surface, the humble melon may just look like a tasty treat to most. But researchers from Japan have found that this fruit has hidden depths: retrotransposons (sometimes called "jumping sequences") may change how genes are expressed.

In a study published recently inCommunications Biology, researchers from the University of Tsukuba and the National Agriculture and Food Research Organization (NARO) have revealed that retrotransposons had a role in altering gene expression when melon genomes were diversifying, and may affect gene expression that induces fruit ripening.

Melons comprise one of the most economically important fruit crops globally. A special feature of melons is the coexistence of two fruit types: climacteric (which produce ethylene and exhibit a burst in cellular respiration as ripening begins), and non-climacteric. Ethylene is a plant hormone important to the regulation of climacteric fruit-ripening traits such as shelf life, which is of major economic importance.

"Because Harukei-3 melons produce ethylene during ripening, we wanted to look at ethylene-related gene expression in this type of melon," says lead author of the study Professor Hiroshi Ezura. "Harukei-3 produces an especially sweet fruit if grown in the right seasons. Because of its taste and attractive appearance, Harukei-3 has been used for a long time in Japan as a standard type for breeding high-grade muskmelon."

To examine ethylene-related gene expression, the researchers assembled the whole genome sequence of Harukei-3 by using third-generation nanopore sequencing paired with optical mapping and next-generation sequencing.

"We compared the genome of Harukei-3 with other melon genomes. Interestingly, we found that there are genome-wide presence/absence polymorphisms of retrotransposon-related sequences between melon accessions, and 160 (39%) were transcriptionally induced in post-harvest ripening fruit samples. They were also co-expressed with neighboring genes," explains Dr. Ryoichi Yano, senior author. "We also found that some retrotransposon-related sequences were transcribed when the plants were subjected to heat stress."

Retrotransposons are transposons (also referred to as "jumping sequences" because they can change their positions within a genome) with sequences similar to those of retroviruses.

"Our findings suggest that retrotransposons contributed to changes in gene expression patterns when melon genomes were diversifying. Retrotransposons may also affect gene expression that brings on fruit ripening," says Professor Ezura.

The Harukei-3 genome assembly, together with other data generated in this study, is available in the Melonet-DB database. Combined with future updates, this database will contribute to the functional genomic study of melons, especially reverse genetics using genome editing.

Reference: Yano et al. (2020).Comparative genomics of muskmelon reveals a potential role for retrotransposons in the modification of gene expression. Communications Biology.DOI: https://doi.org/10.1038/s42003-020-01172-0.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Genetic Study Reveals Theres More to Melons Than Meets the Eye - Technology Networks

Combined Company Positioned to Offer Best-in-Class and Innovative Drug Discovery Solutions

RUTHERFORD, NJ and MAPLE GROVE, MN, Aug. 24, 2020 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (the Company) (Nasdaq: CGIX), and StemoniX, Inc., today announced the entry into a definitive merger agreement. Cancer Genetics is a leader in drug discovery and preclinical oncology and immuno-oncology services. StemoniX, a privatecompany, isa leader in developing high-throughput disease-specifichuman organoid platforms integrated withleading-edge data science technologies. Under the terms of the merger agreement, StemoniX will merge with a newly formed subsidiary of Cancer Genetics in an all-equity transaction. Upon shareholder approval, the combined company expects to remain listed on the Nasdaq Stock Market. StemoniX will retain its name and become a wholly-owned subsidiary of Cancer Genetics.

The transaction will position the combined company to harness the synergies between two critical modalities of drug discovery and development - advanced animal models and relevant human high-throughput organoid platforms. The resulting integration of scientific and technology-based expertise, skilled management teams, and ability to offer customers an end-to-end platform will de-risk and accelerate development of preclinical and clinical pipelines for biopharma partners as well as for the proprietary pipeline of the combined company. In combination, Cancer Genetics and StemoniX currently enjoy partnerships and R&D relationships with dozens of global pharmaceutical and biotechnology companies.

"The process of discovering and developing a new drug candidate takes years and comes with a price tag of hundreds of millions - or even billions - of dollars. However, we are at unique time in the drug discovery industry as the convergence of technological innovations in both biology and software will transform conventional workflows in time and accuracy. To convert the time-consuming and labor-intensive process of developing a drug for market, we now look to supplement traditional discovery and drug approval mechanisms to include humanized cell-based assays with artificial intelligence (AI) along with our core vivoPharm business. Given that our strategy and approach are strongly aligned with those of StemoniX, we are pleased to have moved forward with this proposed transaction," stated Jay Roberts, Chief Executive Officer of Cancer Genetics.

The pharma industry and society are at a critical pivot point. Viral pandemics and diseases lacking treatments require a new way of innovation. The proposed merger expects to expand our ability to engage with a larger audience of potential partners and expand our internal capabilities as we deliver on our mission to rapidly discover the safest and most effective therapeutics on behalf of our partners and our shareholders. The mission will stay consistent - allow scientists to quickly and economically conduct high-throughput toxicity and drug development studies in ready-to-assay plates containing functional microOrgans, stated Ping Yeh, Chief Executive Officer of StemoniX.

ABOUT THE TRANSACTION

Pursuant to the merger agreement, Cancer Genetics will acquire all of the outstanding capital stock of StemoniX in exchange for a number of shares of its common stock which will represent approximately 78% of the outstanding common stock of Cancer Genetics, subject to certain adjustments and prior to the effects of the financing referred to below, with the current equity holders of Cancer Genetics retaining 22% of the common stock immediately following the consummation of the merger.

The Boards of Directors of both companies have approved the proposed merger, which is expected to close in the fourth quarter of 2020, subject to the approval of the shareholders of both Cancer Genetics and StemoniX, financing and other customary closing conditions.

H.C. Wainwright & Co. is acting as financial advisors to the Board of Directors of Cancer Genetics, and Lowenstein Sandler is acting as its legal counsel. Northland Securities, Inc. is acting as financial advisor to the Board of Directors of StemoniX and Taft, Stettinius & Hollister is acting as its legal counsel.

ABOUT CANCER GENETICS

Through its vivoPharm subsidiary, Cancer Genetics offers proprietary preclinical test systems supporting clinical diagnostic offerings at early stages, valued by the pharmaceutical industry, biotechnology companies and academic research centers. The Company is focused on precision and translational medicine to drive drug discovery and novel therapies. vivoPharm specializes in conducting studies tailored to guide drug development, starting from compound libraries and ending with a comprehensive set of in vitro and in vivo data and reports, as needed for Investigational New Drug filings. vivoPharm operates in The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited and GLP compliant audited facilities. For more information, please visit http://www.cancergenetics.com.

ABOUT STEMONIX, INC.

StemoniX is empowering the discovery of new medicines through the convergence of novel human biology and software technologies. StemoniX develops and manufactures high-density, at-scale human induced pluripotent stem (iPSC) cell-derived neural and cardiac screening platforms for drug discovery and development. Predictive, accurate, and consistent, these human models enable scientists to quickly and economically conduct research with improved outcomes in a simplified workflow. Through collaborations with drug discovery organizations, StemoniX tests compounds in-house, creates new cell-based disease models, and operationalizes custom human iPSC disease models at large scale for high-throughput screening. With leading-edge iPSC technologies and data science, StemoniX is helping global institutions bring the most promising medicines to patients. To learn more about how StemoniX products and services are accelerating discoveries, please visit http://www.StemoniX.com.

For more information, please visit or follow CGI at:

http://www.cancergenetics.com

Twitter: @Cancer_Genetics

And StemoniX at:

http://www.StemoniX.com

Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.s expectations regarding satisfaction of closing conditions, consummation of the merger, future financial and/or operating results, and potential for our services, future revenues or growth in this press release constitute forward-looking statements.

Any statements that are not historical fact (including, but not limited to, statements that contain words such as will, believes, plans, anticipates, expects, estimates) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in our ability to satisfy all closing conditions to the merger, our attempts to adapt to the global coronavirus pandemic, achieve profitability by increasing sales of our pre-clinical services, maintain our existing customer base and avoid cancellation of customer contracts or discontinuance of trials, raise capital to meet our liquidity needs and conditions to the merger, properly evaluate strategic options, and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2019 and Form 10-Q for the quarter ended June 30, 2020, along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.

Investor Contacts:Jennifer K. Zimmons. Ph.D.Investor RelationsZimmons International Communications, Inc.Email: jzimmons@zimmonsic.comPhone: +1.917.214.3514

More:
Cancer Genetics and StemoniX Sign Definitive Agreement to Merge - GlobeNewswire

Global CRISPR and Cas Genes Market Snapshot

CRISPR-Cas systems are efficient and easily programmable nucleic acid-targeting tools, with usage expanding beyond research and therapeutic development to precision breeding of plants and animals and engineering of industrial microbes. CRISPR-Cas systems have potential applications in microbial engineering including bacterial strain typing, immunization of cultures, autoimmunity or self-targeted cell killing, and the engineering or control of metabolic pathways for improved biochemical synthesis. The global CRISPR and Cas genes market was valued at US$ 1,451.6 Mn in 2017 and is anticipated to reach US$ 7,234.5 Mn by 2026, expanding at a CAGR of 20.1% from 2018 to 2026.

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Usage of CRISPR-Cas systems in bacteria, rise in government spending on research and development of genome editing, increase in incidence of genetic disorders, and usage of CRISPR/Cas9 technology to improve crop production drive the global CRISPR and Cas genes market. Genome editing technologies such as CRISPR/Cas9 is a revolutionary step in the field of biomedical research. Application of CRISPR/Cas9 focusing on somatic cell genome editing program is aimed at accelerating the use of these technologies to treat various genetic disorders. However, ethical issues concerning CRISPR and lack of skilled professionals restrain the global CRISPR and Cas genes market.

The global CRISPR and Cas genes market has been segmented based on product type, application, end-user, and region. In terms of product type, the global market has been bifurcated into vector-based Cas and DNA-free Cas. Based on application, the global CRISPR and Cas genes market has been classified into genome engineering, disease models, functional genomics, knockout/activation, and others. In terms of end-user, the global market has been categorized into biotechnology & pharmaceutical companies, academic & government research institutes, and contract research organizations. Based on region, the global CRISPR and Cas genes market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

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In terms of product type, the vector-based Cas segment dominated the global market in 2017, accounting for 62.1% share. Vector-based Cas expression systems are useful for researchers who focus on enriching Cas9-expressing cells or strive to establish a stable cell line. Vector-based Cas is also available with an inducible promoter that supports the creation of stable cell lines with minimal background expression, or for temporal control over Cas9 expression for wide-ranging experimental applications. The DNA-free Cas segment is anticipated to gain market share during the forecast period. Advantages such as gene editing with DNA-free CRISPR-Cas9 components to reduce potential off-targets and potential usage of CRISPR-Cas9 gene editing to find correlations with human diseases in model systems drive the segment.

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Based on application, the genome engineering segment dominated the global CRISPR and Cas genes market in 2017. CRISPR technology allows genetic material to be added, removed, or altered at particular locations in the genome. Cas9 mRNA or purified Cas9 protein is the source for Cas9 nuclease expression in genome engineering experiments. Genomic engineering is the synthetic assembly of complete chromosomal DNA that is more or less derived from natural genomic sequences. Disease models was the second largest segment of the global market. CRISPR/Cas9 gene editing has also been applied in immunology-focused applications such as the targeting of C-C chemokine receptor type 5 and programmed death-1 gene. This technology has been increasingly applied in the study or treatment of human diseases, including Barth syndrome effects on the heart, Duchenne muscular dystrophy, hemophilia, -thalassemia, and cystic fibrosis.

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In terms of end-user, the biotechnology & pharmaceutical companies segment dominated the global CRISPR and Cas Gene market in 2017. Adoption of CRISPR technology by pharmaceutical & biotechnology companies through strategic partnerships with innovators drives the segment. In 2017, CRISPR Therapeutics established a joint venture called Casebia Therapeutics LLP with Bayer HeathCare and its subsidiaries. Academic & government research institutes was the second largest segment of the global market.

Based on region, North America and Europe dominated the global CRISPR and Cas genes market in 2017, accounting for 71% share. Rise in research activities and technological advancements are expected to drive the CRISPR and Cas genes market in the regions during the forecast period. In 2016, a human clinical trial was initiated for the use of CRISPR to treat diseases in the U.S. Increase in adoption of technology and presence of key players in the region are likely to accelerate the growth of the CRISPR and Cas genes market in Europe during the forecast period.

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Major players operating in the global CRISPR and Cas genes market include Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc. These players adopt organic and in-organic growth strategies to expand product offerings, strengthen geographical reach, increase customer base, and capture market share.

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CRISPR and Cas Genes Market: Rise in Incidence of Genetic Disorders and Increase in Applications of CRISPR and Cas Genes to Propel Market - BioSpace

A perfect mix of quantitative & qualitative Preimplantation Genetic Diagnostics (PGD)market information highlighting developments, industry challenges that competitors are facing along with gaps and opportunities available and would trend in Preimplantation Genetic Diagnostics (PGD) market. The study bridges the historical data from 2014 to 2019 and estimated until 2026.

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COVID-19 Update: Global Preimplantation Genetic Diagnostics (PGD) Market is Expected to Grow at a Healthy CAGR with Top players: Illumina, Inc.,...

The Federal Circuit has issued a precedential decision in XY LLC v Trans Ova Genetics. Judge Stoll, joined by Judge Wallach and Senior Judge Plager, held that claims directed to a specific improvement to an otherwise-known process are patent eligible under 35 USC section 101. In reversing the district court, the court held that, although the invention applies mathematical equations to effect the claimed improvement, the claims were directed to a specific improvement that separates the invention from the prior art - not to an abstract idea.

The courts decision details several principles underlying the section 101 analysis and offers lessons for litigants addressing eligibility determinations.

XYs 559 patent involves flow cytometry technology for sorting non-human mammalian particles. This technology is particularly useful in animal breeding to guarantee the sex of offspring, allowing sperm cells to be sorted based on whether the cell carries an X or Y chromosome. While conventional flow cytometry technology made it difficult to discriminate between similar particles of different populations, the 559 patent claims an improvement that uses mathematical equations to reconfigure data corresponding to the particles, such as by rotating it, in order to increase spatial separation of data points and make it possible to discriminate between particles. XYs improved methods allow populations to be selected more accurately than in any other prior art system.

The district court decided the 559 patent claims were invalid under section 101. Starting with Alice step one, the court found the claims were directed to the abstract idea of a mathematical equation that permits rotating multi-dimensional data. It reasoned that, although the equation helps to discriminate between particles of different populations, the invention reduces down to applying a mathematical concept. Then, at Alice Step Two, the court held the asserted claims lack an inventive concept because it believed the claims offer nothing beyond the prior art.

Reversing the district court, the Federal Circuit decided on 31st July that the 559 patent claims are directed to a specific improvement to a flow cytometry method, not an abstract idea. Specifically, the court held the claims are directed to an improved method for classifying and sorting particles based on the specific steps set forth in the claims, thereby facilitating classification and sorting of each individual particle more accurately than any prior art method. Although the patent used mathematical equations to implement the improvement, the court found the claims were directed to an improvement to the method itself that so happened to use math. Because the court held that the claims are not directed to an abstract idea at Alice step one, it did not move on to step two.

The courts decision and its section 101 analysis offers several valuable lessons for litigants:

This pattern underscores the need for both patentees and challengers to make their case at Step One. Is it an improvement to an existing technology that so happens to use an abstract idea to implement that improvement, or are the claims directed to an improvement to the abstract idea itself? In XY, the invention improved a known flow cytometry process by applying a mathematical formula. While the court held that claimed improvement passed the Alice test, a claim directed to improving the mathematical formula by itself would likely not be eligible. XY makes clear that it is critical for patentees and challengers alike to define what the claims are directed to, knowing that step one is likely going to make or break the section 101 decision.

It is therefore critical for litigants to articulate, at Step One, what solutions existed in the prior art and why (or why not) the claims represent an improvement to those solutions. XY confirms the courts holding in Thales Visionix v United States that improving the accuracy of a prior art solution can be enough to make the claims a patentable improvement. Moreover, if a party can tie the claimed improvement to a physical process or product, all the better. The XY court found important the fact that the claimed method resulted in separation of physical particles, like the claimed improvement in Diamond v Diehr produced a perfectly-cured synthetic rubber product.

The Federal Circuits decision in XY confirms that claimed improvements to the prior art can be patent-eligible, even if the claims use an abstract idea such as a mathematical formula to execute the improvement. Litigants addressing section 101 challenges should focus on articulating what the claimed invention is, how it relates to the prior art, and how the claims compare to others that courts have already held to be eligible, or ineligible, under section 101.

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Three lessons from the Federal Circuit's recent 101 reversal in XY v Trans Ova Genetics - IAM