StemCell Therapy

IRVINE, Calif.--(BUSINESS WIRE)--GATC Health, an innovative technology company focused on whole genome testing and Predictive Multiomics, today announced the completion of its Viral Immunity Platform (VIP), a prediction tool for personal immune response analysis. VIP can predict the likelihood of infection and severity of outcomes for SARS-CoV-2 and other viral infections.

VIP runs on the companys Multiomic Advanced Technology (MAT), which combines machine learning, neural networks, deep sequencing and bioinformatics in a comprehensive platform. MAT integrates personal metadata to accurately predict individual immunity response to agents compromising the immune system. MAT also combines advanced AI systems and quantitative genomics, proteomics and microbiomics to decipher billions of datapoints, delivering extremely accurate results.

VIP provides personalized medical analysis that assesses risk of infection, predicts immune response, identifies potential complications, and could even provide therapeutic guidance. The results enable patients and physicians to make informed decisions about individual immunity and safety, including who can return to work, who should attend social gatherings, who may have a moderate illness, and who is at high risk for a serious infection or prone to complications.

In our current climate, its more important than ever to have accurate information about how we will react to COVID or other viral infections so that we can make well-educated decisions, said John Stroh, Interim CEO of GATC Health. Our new VIP technology platform has the ability to provide predictive, actionable information about how an individual will respond when exposed to a virus. Armed with this knowledge, physicians and patients can make decisions to reduce their risk of infection, determine the most likely course of an infection if it does occur, and plan the appropriate treatment.

GATC Healths Viral Immunity Platform will provide customers with a personalized report outlining predicted viral infection risk, immunity response, and potential complications. VIP is expected to be available for consumers and physicians in Q2 2021.

About GATC Health

GATC Health is a pioneering technology company using Predictive Multiomics to advance drug discovery and improve human health. GATC Healths proprietary Multiomic Advanced Technology (MAT) sequences an individuals DNA, reading the entire genome and analyzing the full data set of omics, including genomics, proteomics, and microbiomics. A complete understanding of a persons genetics combined with the evaluation of other omics yields the most comprehensive individual health analysis available, which can lead to fast-tracking drug development, pre-screening clinical trial participants, identifying new drugs and repurposing existing treatments. GATC Healths innovative technology can help take healthcare from reactive to predictiveit is truly personalized medicine. For more information about GATC Health, visit http://www.GATCHealth.com.

Disclaimer

The information set forth herein is presented for informational purposes only and should not be deemed an offer to sell securities. This presentation contains information which the Company believes to be correct, including certain financial information and projections, but the Company does not guarantee as to the accuracy or completeness of such information. The Company reserves the right to modify or amend the information contained herein.

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GATC Health Introduces Personalized Immunity Platform to Predict Individual Response to SARS-CoV-2 and Other Viral Infections - Business Wire

Dublin, Feb. 12, 2021 (GLOBE NEWSWIRE) -- The "Biobanking Market by Specimen Type, Type of Biobank, Ownership, and Application: Global Opportunity Analysis and Industry Forecast, 2020-2027" report has been added to ResearchAndMarkets.com's offering.

The global biobanking market was valued at $37. 93 billion in 2019, and is estimated to reach $57. 67 billion by 2027, growing at a CAGR of 4. 6% from 2020 to 2027.

Biobank is a biorepository meant to collect and preserve biological materials that are used for diagnosis, biodiversity studies, and research. In addition, it is used to support the research of most common types of genetic disorders to develop personalized medicines and to maintain and update database of diseases related to age.

The rise in funding by private & government organizations for biobanking and increase in application areas of bio banked samples are the major factors that drive the growth of the global biobanking market. Moreover, upsurge in incidence of diseases such as cancer significantly contributes toward the market growth, owing to the fact that biobanked specimens are used in the treatment of several chronic diseases. However, ethical issues related to biobanking and lack of awareness about it are expected to impede the market growth. On the contrary, advancements in stem cell research and unmet medical needs in emerging nations are anticipated to provide lucrative opportunity for the market expansion.

The rise in genomic research activities acts as a key driving force of the global market. Furthermore, government is taking multiple initiatives to support regenerative medicine research, which is expected to boost the market growth. Moreover, increase in demand for cost-effective drug delivery & development accelerates the market growth. Furthermore, usage of human biospecimens is increasing in cohort studies. Number of registered clinical studies with the National Institutes of Health (NIH) increased from 181,305 in 2014 to 262,445 in 2017. A substantial number of large ongoing cohort studies related to precision medicine have fomented the establishment of population-based banks.

The global biobanking market is segmented into specimen type, type of biobank, ownership, application, and region. Depending on specimen type, the market is categorized into blood products, solid tissue, cell lines, nucleic acid, and others. On the basis of ownership, it is divided into national/regional agencies, nonprofit organization, universities, and private organization. The applications covered in the study include therapeutic and research. By type of biobank, the market is bifurcated into population-based biobank and disease-oriented biobank. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Some of the major companies that operate in the global market for biobanks are BioIVT & Elevating Science, Geneticist Inc, Firalis S. A., AMS biotechnology Ltd. (AMSBIO LLC), and US Biolab Corporation, Inc., ProteoGenex, Inc., Cureline, Inc., Bay Biosciences LLC, CTI Biotech, and Boca Biolistics.

Key Benefits

Key Topics Covered:

Chapter 1: Introduction1.1. Report Description1.2. Key Benefits for Stakeholders1.3. Key Market Segments1.1. Research Methodology1.1.1. Secondary Research1.1.2. Primary Research1.1.3. Analyst Tools and Models

Chapter 2: Executive Summary2.1. Key Findings of the Study2.2. Cxo Perspective

Chapter 3: Market Overview3.1. Market Definition and Scope3.2. Key Findings3.2.1. Top Investment Pockets3.2.2. Top Player Positioning3.3. Porter'S Five Forces Analysis3.4. Market Dynamics3.4.1. Drivers, Restraints, and Opportunity3.4.2. Drivers3.4.2.1. The Rise in Funds for Biobanks3.4.2.2. Increase in R&D Activities for Application of Biobank Specimens3.4.2.3. Surge in Prevalence of Fatal Chronic Diseases3.4.3. Restraints3.4.3.1. Legal and Ethical Issues of Biobanking3.4.3.2. Lack of Awareness Toward Biobanking3.4.4. Opportunity3.4.4.1. High Growth Potential in Developing Countries3.5. Impact of Covid-19 on Biobanking Market3.5.1. Overview3.5.2. Impact Analysis3.5.3. List of 10 Largest Biobanks Across the Globe

Chapter 4: Biobanking Market, by Specimen Type4.1. Overview4.1.1. Market Size and Forecast4.2. Blood Products4.2.1. Key Market Trends and Opportunities4.2.2. Market Size and Forecast, by Region4.2.3. Market Analysis, by Country4.3. Solid Tissues4.3.1. Key Market Trends and Opportunities4.3.2. Market Size and Forecast, by Region4.3.3. Market Analysis, by Country4.4. Cell Lines4.4.1. Key Market Trends and Opportunities4.4.2. Market Size and Forecast, by Region4.4.3. Market Analysis, by Country4.5. Nucleic Acid4.5.1. Key Market Trends and Opportunities4.5.2. Market Size and Forecast, by Region4.5.3. Market Analysis, by Country4.6. Others4.6.1. Key Market Trends and Opportunities4.6.2. Market Size and Forecast, by Region4.6.3. Market Analysis, by Country

Chapter 5: Biobanking Market, by Type of Biobank5.1. Overview5.1.1. Market Size and Forecast5.2. Population-Based Biobanks5.2.1. Key Market Trends and Opportunities5.2.2. Market Size and Forecast, by Region5.2.3. Market Analysis, by Country5.3. Disease-Oriented Biobanks5.3.1. Key Market Trends and Opportunities5.3.2. Market Size and Forecast, by Region5.3.3. Market Analysis, by Country

Chapter 6: Biobanking Market, by Ownership6.1. Overview6.1.1. Market Size and Forecast6.2. National/Regional Agencies6.2.1. Key Market Trends and Opportunities6.2.2. Market Size and Forecast, by Region6.2.3. Market Analysis, by Country6.3. Nonprofit Organization6.3.1. Key Market Trends and Opportunities6.3.2. Market Size and Forecast, by Region6.3.3. Market Analysis, by Country6.4. Universities6.4.1. Key Market Trends and Opportunities6.4.2. Market Size and Forecast, by Region6.4.3. Market Analysis, by Country6.5. Private Organization6.5.1. Key Market Trends and Opportunities6.5.2. Market Size and Forecast, by Region6.5.3. Market Analysis, by Country

Chapter 7: Biobanking Market, by Application7.1. Overview7.1.1. Market Size and Forecast7.2. Therapeutic7.2.1. Key Market Trends and Opportunities7.2.2. Market Size and Forecast, by Region7.2.3. Market Analysis, by Country7.3. Research7.3.1. Key Market Trends and Opportunities7.3.2. Market Size and Forecast, by Region7.3.3. Market Analysis, by Country

Chapter 8: Biobanking Market, by Region8.1. Overview8.2. North America8.3. Europe8.4. Asia-Pacific8.5. LAMEA

Chapter 9: Company Profiles9.1. Ams Biotechnology Ltd. (Amsbio LLC)9.1.1. Company Overview9.1.2. Company Snapshot9.1.3. Operating Business Segments9.1.4. Product Portfolio9.2. Bay Biosciences LLC9.2.1. Company Overview9.2.2. Company Snapshot9.2.3. Operating Business Segments9.2.4. Product Portfolio9.3. Bioivt & Elevating Science9.3.1. Company Overview9.3.2. Company Snapshot9.3.3. Operating Business Segments9.3.4. Product Portfolio9.3.5. Key Strategic Moves and Developments9.4. Boca Biolistics9.4.1. Company Overview9.4.2. Company Snapshot9.4.3. Operating Business Segments9.4.4. Product Portfolio9.5. Cti Biotech9.5.1. Company Overview9.5.2. Company Snapshot9.5.3. Product Portfolio9.6. Cureline, Inc.9.6.1. Company Overview9.6.2. Company Snapshot9.6.3. Operating Business Segments9.6.4. Product Portfolio9.7. Firalis S. A.9.7.1. Company Overview9.7.2. Company Snapshot9.7.3. Operating Business Segments9.7.4. Product Portfolio9.8. Geneticist Inc.9.8.1. Company Overview9.8.2. Company Snapshot9.8.3. Operating Business Segments9.8.4. Product Portfolio9.9. Proteogenex, Inc.9.9.1. Company Overview9.9.2. Company Snapshot9.9.3. Operating Business Segments9.9.4. Product Portfolio9.10. Us Biolab Corporation, Inc.9.10.1. Company Overview9.10.2. Company Snapshot9.10.3. Operating Business Segments9.10.4. Product Portfolio

For more information about this report visit https://www.researchandmarkets.com/r/5gm10t

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Outlook on the Biobanking Global Market to 2027 - Opportunity Analysis and Industry Forecasts - GlobeNewswire

Chinese pharmaceutical and 3D printing technology firm Triastek has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its first 3D printed drug product, T19.

T19 has been developed in-house and is designed to treat rheumatoid arthritis, which is an autoimmune disease where the bodys immune system attacks the cells that line joints by mistake, making them stiff and swollen.

Triastek 3D printed the drug product using its Melt Extrusion Deposition (MED) technology platform and has global intellectual property (IP) rights to its 3D printed formulation.

Triastek is committed to improving the efficiency of formulation development, enhancing the effects of drug products, and ensuring the quality of drug delivered to patients by using the 3D printing technology platform, said Dr. Senping Cheng, Co-founder and CEO of Triastek. The FDA IND clearance of T19 is an important milestone in the development and application of MED 3D printing technology.

MED 3D printing platform

Triasteks MED 3D printing technology platform uses digital pharmaceutical dosage form design and automated intelligent manufacturing to enable the construction of tablets with sophisticated shapes and internal geometric structures. These structures allow the onset time, duration, and mode of drug delivery to be closely controlled and adjusted, which in turn provides more predictable and reproducible drug delivery results.

By enabling greater customization of the printed drugs, the MED system can help to enhance the therapeutic effects of medicines, while lowering side effects and improving compliance with patients. Triasteks novel pharmaceutical product development method, 3D formulation by Design (3DFbD) can be used in tandem with MED 3D printing technology to reduce the need for trial and error often required during traditional formulation development processes. 3DFbD is designed to improve both the efficiency and success rate of Triasteks drug product development in order to accelerate development time and lower costs.

The firm has also integrated real-time Process Analytical Technology (PAT) into the MED system that can continually monitor the 3D printing process to ensure product quality and make regulatory monitoring more convenient.

In April last year, the MED platform was accepted into the FDAs Emerging Technology Program (ETP) which recognized the 3D printing technology as a fully automated process for the manufacture of modified release solid oral dosage forms.

We believe that the MED 3D printing technology will be the enabler for digital pharmaceutical product development and intelligent drug manufacturing, said Dr. Xiaoling Li, Triasteks Co-founder and CSO. Triastek will work with any interested parties to take advantage of the platform technology for developing pharmaceutical products with better clinical value and higher product quality.

A chronotherapeutic drug delivery system

According to Triastek, deploying 3D printing for T19s novel design permits it to function as a chronotherapeutic drug delivery system. Chronotherapy treatment is based on the idea that administering medicine at different times of the circadian cycle the bodys natural internal process that regulates sleep over a 24 hour period will maximize a drugs therapeutic impact while minimizing side effects.

The T19 tablet is 3D printed on Triasteks MED system in a specific shape and with a precise internal geometric structure that facilitates the precise control of the drugs release to achieve the desired uptake by the patient. Taken at bedtime, T19s design means the drug will be released in a delayed manner so that blood concentration peaks when symptoms of pain and joint stiffness are most acute, such as in the early hours of the morning.

Having received IND clearance from the FDA for T19, Triastek is planning to apply for the same approval in China later this year, followed by applications in Japan and Europe. The firm expects to file a New Drug Application (NDA) for T19 to the FDA in 2023, and announced it has also developed a 505(b)(2) product portfolio using MED 3D printing technology to improve the outcomes of drug therapy.

3D printing and drug delivery

Personalized medication for individual patients is a fast-growing area of interest within the 3D printed pharmaceutical field. 3D printing enables the size and geometries of tablets and drug delivery devices to be modified to control their release and dosages depending on clinical need.

In 2015, Aprecia Pharmaceuticalsreceived FDA approvalfor its 3D printed Spiritam medication, making it the first 3D printed pharmaceutical to be approved by the FDA. The medication is designed to treat seizures in people with epilepsy and was approved for commercial manufacturing operations later that year. Aprecia recently announced a long-term collaboration with R&D firm Battelle to expand its capabilities within 3D printed pharmaceuticals and advance its 3D printing equipment from clinical supply to commercial scale. The firm has also previously partnered with Cambridge-basedCycle Pharmaceuticalsto produce orphan drugs for thetreatment of rare medical conditionsusing its ZipDose 3D printing process.

3D printed pharmaceuticals firm FabRx has also been active on the printed drug development front, having produced personalized medicine for children with the rare metabolic disorder maple syrup urine disease (MSUD), and printed its chewable Printlet tablets with Braille and Moon patterns on the surface to aid medicine taking for patients with visual impairment. The company launched its M3DIMAKER 3D printer in April 2020, designed specifically for the manufacture of personalized drug delivery devices.

Elsewhere, global pharmaceutical firm Merck has announced plans to work with EOS Group company ACMC to produce 3D printed tablets first for clinical trials, then later for commercial manufacturing. Meanwhile, in the research realm 3D printing has been used to optimize the controllable dosage of antibiotic tablets, and semi-solid extrusion 3D printing has been explored as a coating technology for customizing the release rate of patient-specific drugs.

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Featured image showsTriastek has gained IND clearance from the FDA for its T19 drug for rheumatoid arthritis. Image via Triastek.

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Triastek receives FDA IND clearance for 3D printed drug to treat rheumatoid arthritis - 3D Printing Industry

Newswise George Mason UniversitysCollege of Scienceannounced an exciting $1.33 million collaboration withRutgers Cancer Institute of New Jerseyand Masons Center for Applied Proteomics and Molecular Medicine (CAPMM) which taps cancer research diagnostics and treatment strengths within the medical facilities and CAP/CLIA laboratory respectively of the two regional powerhouses.

The effort will use a new way to measure biomarkers of the HER2 protein, which is expressed on breast cancer cells. Women who have this protein get specific therapies, now part of the standard of care in both early stage and metastatic settings of breast cancer.

The projects overall goal is clinical validation, in two independent patient cohorts from the Rutgers Cancer Institute, of a new way for measuring HER2 based on its activation (phosphorylation) and predicting, using only the patients diagnostic biopsy, whether or not that patient will respond favorably to the treatment.

The Mason-developed test uses a new Fluidigm laser capture microdissection (LCM), which enables researchers to capture cellular regions of interest from frozen and FFPE tissue sections for downstream analysis using DNA and RNA sequencing, real-time PCR or mass spectrometry analysis. The test is designed for patients with HER2 positive breast tumors to predict if each patient will achieve a complete remission of the tumor so that the tumor is completely absent and cannot even be found on pathologic tissue examination.

We aim to emerge from this short-term, high-impact effort with established cut-points, reagents, and CLIA/CAP SOPs developed and validated for our assay that would be published for general use, saidLance Liotta, MD, PhD, study PI, and CAPMM co-founder and co-director.

During the first year of the partnership, researchers will measure HER2 activation retrospectively on previously collected cancer specimens and cross reference it with treatment outcomes. During the second year, those findings will help inform the design of prospective trials enabling real-time decision making influencing the selection of future therapy options offered to patients at Rutgers Cancer Institute and RWJBarnabas Health.

We believe the test can have great benefit for individualizing therapies, added, Dr. Emanuel Petricoin, PhD, Co-PI of the study and also co-founder and co-director of Mason CAPMM. Clinical studies have supported the recent approval of two escalation strategies, unfortunately, these escalations are associated with considerable increased costs and additional risks of toxicity, Petricoin explained.

Therefore, careful and accurate patient risk stratification up-front, to identify which patients will benefit most from treatment, is essential to minimize risk and maximize benefit, said Rutgers Cancer Institutes principal investigator,Shridar Ganesan, MD, PhD, chief of molecular oncology, associate director for translational research, and Omar Boraie Chair in Genomic Science.

If validated, this predictor may help lead to development for modified or, de-escalated regimens for patients who score at low risk for recurrence or high chance of complete pathologic response Similarly, patients who score at high risk of recurrence or low chance of complete pathologic response from current standard therapy may benefit from trials exploring other treatment approaches.

The tests will be conducted on the pretreatment biopsy tissue we have collected and directly evaluate the molecular target of the major classes of HER2 neoadjuvant therapies, said Ganesan, a professor of medicine and pharmacology at Rutgers Robert Wood Johnson Medical School who had previously collaborated with Liotta while he was at the NIH.

This partnership allows us to continue to provide the most advanced treatment options possible for our patients, Ganesan added.

The teams plan also includes a rapid deployment of the testing if it proves conclusive.

Weve partnered with Theralink Diagnostics, Inc. who will be responsible for the assay commercialization and expanded clinical assessment to provide an accelerated adoption and clinical use by medical oncologists, saidEmanuel Petricoin, CAPMM co-director, and a scientific advisor to the Company. We have set up the infrastructure to quickly deploy the information and technology; if this holds true, we have a commercial partner ready to take it to the bedside as part of a patient clinical care plan and treatment decision support tool, Petricoin explained.

This is a smart, strategic partnershipboth Rutgers and Mason each bring invaluable expertise and infrastructure to minimize time to market and maximize research impact, said Mason College of Science dean, Fernando Miralles-Wilhelm. Mason scientists created the protein measurement test and offer CAP/CLIA facilities that dovetail well with the existing biobank of tissue samples and preeminent therapeutic cancer treatments options offered to patients at Rutgers Cancer Institute of New Jersey, Miralles-Wilhelm added.

The College of Science at George Mason University

Mason's College of Science is a leader in scientific discovery and a creator of innovative solutions for the rapidly-changing needs of today's world. The college prides itself in being home to a diverse population of students and researchers serving as a magnet for all scientific minds. With new discoveries, our scientists continue to grow Mason's portfolio of patents, licenses, partnerships, and spin off companies.

The college blends traditional science education with sought-after programs at all levels to challenge and engage in disciplines including personalized medicine, infectious diseases, drug discovery, climate dynamics, environmental justice and conservation, materials science, astronomy, forensic science, computational science, and applied mathematics. Mason's College of Science offers enhanced undergraduate and graduate academic and research opportunities, including innovative minors, certificates, and graduate degrees, that allow professionals to upskill or change careers. Learn more atscience.gmu.edu

About George Mason University

George Mason University is Virginia's largest public research university. Located near Washington, D.C., Mason enrolls more than 39,000 students from 130 countries and all 50 states. Mason has grown rapidly over the last half-century and is recognized for its innovation and entrepreneurship, remarkable diversity, and commitment to accessibility. Visithttp://www.gmu.edu

About Rutgers Cancer Institute of New Jersey

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, offers the most advanced cancer treatment options including bone marrow transplantation, proton therapy, CAR T-cell therapy and complex surgical procedures. Along with clinical trials and novel therapeutics such as precision medicine and immunotherapy - many of which are not widely available - patients have access to these cutting-edge therapies at Rutgers Cancer Institute of New Jersey in New Brunswick, Rutgers Cancer Institute of New Jersey at University Hospital in Newark, as well as through RWJBarnabas Health facilities. Learn more atcinj.org

The rest is here:
Mason Scientists and Rutgers Cancer Institute of New Jersey Collaboration Receives U.S. Armys Breakthrough Award to Better Inform HER2 Breast Cancer...

DUBLIN--(BUSINESS WIRE)--The "Companion Diagnostic Markets - the Future of Diagnostics, by Funding Source and Application with Customized Forecasting/Analysis, COVID-19 Updates, and Executive and Consultant Guides 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Will Personalized Companion Diagnostics become the norm for diagnostics?

Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is finally moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. But COVID-19 is impacting healthcare treatment everywhere and lowering demand for specialized cancer testing. Find out the latest outlook for this important market.

Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. The science is racing forward. And the cost of molecular diagnostics continues to fall.

Key Topics Covered:

Companion Diagnostic Market - Strategic Situation Analysis

1. Introduction and Market Definition

1.1 What are Companion Diagnostics?

1.2 The Personalized Medicine Revolution

1.3 Market Definition

1.4 Methodology

1.5 A Spending Perspective on Clinical Laboratory Testing

2. Market Overview

2.1 Players in a Dynamic Market

2.1.1 Academic Research Lab

2.1.2 Diagnostic Test Developer

2.1.3 Instrumentation Supplier

2.1.4 Distributor and Reagent Supplier

2.1.5 Independent Testing Lab

2.1.6 Public National/regional lab

2.1.7 Hospital lab

2.1.8 Physician Office Labs

2.1.9 Audit Body

2.1.10 Certification Body

2.2 Personalized Medicine and Companion Diagnostics

2.2.1 Basics

2.2.2 Method

2.2.3 Disease risk assessment

2.2.4 Applications

2.2.5 Diagnosis and intervention

2.2.5.1 Companion Diagnostics

2.2.6 Drug development and usage

2.2.7 Respiratory proteomics

2.2.8 Cancer genomics

2.2.9 Population screening

2.2.10 Challenges

2.2.11 Regulatory oversight

2.2.12 Intellectual property rights

2.2.13 Reimbursement policies

2.2.14 Patient privacy and confidentiality

2.3 Chromosomes, Genes and Epigenetics

2.3.1 Chromosomes

2.3.2 Genes

2.3.3 Epigenetics

2.4 Cancer Genes

2.4.1 Germline vs Somatic

2.4.2 Changing Clinical Role

2.5 Structure of Industry Plays a Part

2.5.1 New Pharmaceutical Funding Market

2.5.2 Economies of Scale

2.5.2.1 Hospital vs. Central Lab

2.5.3 Physician Office Labs

2.5.4 Physicians and POCT

3. Market Trends

3.1 Factors Driving Growth

3.1.1 Level of Care

3.1.2 Immuno-oncology

3.1.3 Liability

3.1.4 Aging Population

3.2 Factors Limiting Growth

3.2.1 State of knowledge

3.2.2 Genetic Blizzard.

3.2.3 Protocol Resistance

3.2.4 Regulation and coverage

3.3 Instrumentation and Automation

3.3.1 Instruments Key to Market Share

3.3.2 Bioinformatics Plays a Role

3.4 Diagnostic Technology Development

3.4.1 Next Generation Sequencing Fuels a Revolution.

3.4.2 Single Cell Genomics Changes the Picture

3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment

3.4.4 CGES Testing, A Brave New World

3.4.5 Biochips/Giant magneto resistance based assay

4. Companion Diagnostics Recent Developments

4.1 Recent Developments - Importance and How to Use This Section

4.1.1 Importance of These Developments

4.1.2 How to Use This Section

5. Profiles of Key Players

6. The Global Market for Companion Diagnostics

6.1 Global Market Overview by Country

6.2 Global Market by Application - Overview

6.3 Global Market Funding Source - Overview

7. Global Companion Diagnostic Markets - By Application

7.1 Oncology

7.2 Neurology

7.3 Cardiology

7.4 Other Application

8. Global Companion Diagnostic Markets - Funding Source

8.1 Global Market Pharmaceutical

8.2 Global Market Venture

8.3 Global Market Clinical

8.4 Global Market Other Funding

For more information about this report visit https://www.researchandmarkets.com/r/f07ek

Original post:
Global Companion Diagnostic Markets Report 2021: A Steep Growth Curve Interrupted by COVID-19 - Forecast to 2025 - ResearchAndMarkets.com - Business...

WALTHAM, Mass.--(BUSINESS WIRE)--BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, and Weill Cornell Medicine, today announced a publication in Cancer Discovery, a journal of the American Association for Cancer Research. The manuscript Clinical and biological subtypes of B-cell lymphoma revealed by microenvironmental signatures highlights the tumor microenvironment as a critical component of B-cell lymphoma biology and the effects of different microenvironments on diffuse large B-cell lymphoma (DLBCL) clinical behavior, establishing a significant opportunity for the development of novel and personalized therapeutic strategies for this disease.

In this research study, the microenvironment subtypes of over 4,600 DLBCL patients were classified using curated and refined transcriptional signatures encompassing key microenvironment and cancer cells activities and processes. This analysis revealed four distinct DLBCL microenvironments (LMEs), each with its own set of unique biological and clinical properties. The LMEs were also found to correlate with different clinical outcomes and prognoses, and downstream preclinical mechanistic studies demonstrated that the LMEs could be applied in clinical decision-making for DLBCL patients.

This study was designed to evaluate the role of the tumor microenvironment in DLBCL biology, said Leandro Cerchietti, M.D., Associate Professor of Medicine and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. The results revealed distinct DLBCL microenvironments with unique therapeutic vulnerabilities that can be utilized for optimization of DLBCL treatment strategies.

The data demonstrate that this novel classification platform provides a roadmap for the therapeutic exploitation of the tumor microenvironment in DLBCL patients, said Nathan Fowler, MD, Chief Medical Officer at BostonGene. Together with Weill Cornell Medicine, we look forward to identifying new treatment strategies to ultimately improve the clinical outcomes of these patients.

About BostonGene Corporation

BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision making in the fight against cancer. BostonGenes unique solution performs sophisticated analytics to aid clinicians in their evaluation of viable treatment options for each patient's individual genetics, tumor and tumor microenvironment, clinical characteristics and disease profile. BostonGenes mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies. For more information, visit BostonGene at http://www.BostonGene.com.

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BostonGene and Weill Cornell Medicine Announce Publication in Cancer Discovery Revealing the Role of the Tumor Microenvironment in the Clinical...

MINNEAPOLIS, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, announced today that it will start an in-house drug repurposing project, focused on ovarian cancer, using its proprietary AI-driven, patient centric discovery platform PeDAL. The project will use PeDAL to rapidly and cost-effectively profile panel of existing drugs against hundreds of patient cell lines. This process will generate data on which compounds are active against which specific patient profile(s), delivering both proof data for the PeDAL approach and valuable Intellectual Property (IP) for the company.

With our Helomics divisions deep experience in clinical profiling of patient tumor drug response, plus our unique PeDAL platform, we have all the components to perform in-house drug repositioning and even full drug discovery. We are very excited to kick-off this first project focused on ovarian cancer. Our expectations are that the project will have significant value by generating proof data for our PeDAL approach, which will be useful in our commercial discussions with Pharmaceutical companies. In addition, the project will also demonstrate the long-term value of Helomics unique data, explained Dr. Carl Schwartz, CEO of Predictive Oncology.

Looking forward, we strongly believe successful execution of this project will demonstrate that Predictive Oncology is emerging as a leader in AI-driven drug discovery, commented Dr. Schwartz.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement, and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins, and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements because of a variety of factors including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:

Landon Capital Keith Pinder (404) 995-6671kpinder@landoncapital.net

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Predictive Oncology's Wholly Owned Subsidiary Helomics announces the start of its drug repurposing project using its ground-breaking PeDAL platform...

The collaboration with the Spanish Lung Cancer Group (Grupo Espaol de Cncer de Pulmn GECP), a Spanish cooperative group for the research on lung cancer, is to show the potential of SOPHiA Radiomics a groundbreaking application that analyzes medical images for research use put to use in an additional retrospective analysis of the data from the phase 2 NADIM clinical trial (NCT03081689) (the NADIM trial).

The NADIM trial, funded by Bristol-Myers Squibb and part of the European Union's Horizon 2020 research and innovation program, aimed to assess the antitumor activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC. The important results recently published in TheLancet Oncology supported the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with resectable stage IIIA NSCLC. This very aggressive type of cancer is unfortunately terminal in most patients with locally advanced staged disease; these results could therefore support a change of perception of locally advanced lung cancer as a potentially lethal disease to one that is curable.

Additional data are expected to be generated through the analysis of the radiology images of NADIM patients through the SOPHiA Radiomics Platform. These data will then be combined with clinical, biological, and genomics data, and multimodal machine learning models will be developed to predict response to neoadjuvant treatment, using baseline and pre-surgery data. The predictive analysis will also aim to stratify patient cohorts with regard to progression-free and overall survival.

"We are very happy to collaborate in this innovative and revolutionary project that opens the door to a new precision medicine. Certainly, this partnership will improve the knowledge relating to the treatment for this group of patients and will allow to approach the best prospects for curing early-stage non-small cell lung cancer (NSCLC)," said Dr. Mariano Provencio, Head of the Medical Oncology Department at Puerta de Hierro University Hospital in Madrid and lead investigator of the NADIM trial.

"We are very excited to apply our radiomics and multimodal analytics capabilities to such an important clinical question," said Prof. Thierry Colin, Vice-President of Radiomics Research at SOPHiA GENETICS. "In the Spanish Lung Cancer Group, we have found visionary partners that clearly see the promise of next-generation health data such as radiomics being married with tech-enabled solutions in artificial intelligence to generate entirely novel clinical insights for the benefit of oncology patients."

"Unlocking the synergistic potential of multimodal health data through artificial intelligence holds revolutionary promise for the future of personalized medicine in oncology and many other health conditions. We are inspired by the potential to positively impact on patients by supporting their care providers in predicting the best course of treatment," said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS.

The NADIM trial involved 18 centers from the Spanish Lung Cancer Network that will contribute their data to the joint project.

Results from the additional analysis of NADIM trial data are expected to be available later this year.

About SOPHiA GENETICS

SOPHiA GENETICS is a health tech company democratizing Data-Driven Medicine to improve health outcomes and economics worldwide. By unlocking the power of new-generation health data for cancer and rare diseases management, the universal SOPHiA Platform allows clinical researchers to act with precision and confidence. The company's innovative approach enables an ever-expanding community of over 1,000 institutions to benefit from knowledge sharing, fostering a new era in healthcare. SOPHiA's achievement is recognized by the MIT Technology Review's "50 Smartest Companies".

More info: SOPHiAGENETICS.COM, follow @SOPHiAGENETICS on Twitter.

About the Spanish Lung Cancer Group

The SLCG is an independent, non-profit, cooperative group founded in 1991 to promote the study and research of lung cancer. The group is composed of 525 medical professionalsoncologists, thoracic surgery specialists, radiotherapists and basic researchersand unites 177 public and private centers across Spain.The group has treated over 37,000 patients in different studies and clinical trials, the results of which have been presented and published at national and international congresses and in leading medical journals.

More info: gecp.com, follow @gecp_org on Twitter.

SOPHIA GENETICS Media ContactSophie ReymondPR & Communications Manager [emailprotected]+41 79 863 11 10

SLCG ContactRita Perales [emailprotected] +34 670 24 70 50

SOURCE SOPHiA GENETICS

https://www.sophiagenetics.com/

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SOPHiA GENETICS and the Spanish Lung Cancer Group Team Up to Explore the Predictive Potential of Multimodal Health Data in Resectable Stage IIIA...

In recent years, the idea of the microbiome has gone from being an esoteric term used in scientific circles, to a mainstream concept employed in adverts to sell microbiome-boosting health drinks and supplements. The increase in public interest has been fed by a series of headline-grabbing research breakthroughs, and the fact that the microbiome has a key role to play in the development of precision medicine.The trillions of microbes contained in the human body are a key element of a personalized approach to treatment; the microbiome influences endocrinology, physiology, and even neurology, and has a crucial role in disease progression. The growing awareness of the various ways in which microbiota affects each of us individually in sickness and in health is also leading to an increase in research. An area in which this interest is growing particularly quickly is oncology.

Multiple publications implicate microbiota in the onset and progression of cancers, as well as toxicity and the response rate of cancer treatments. An analysis of 12 million full-text publications, 29 million abstracts and 521 thousand grant applications for semantic relations between cancers and microbiota is shown in figure 1. The data show a considerable increase in the number of articles linking cancers to microbiota for five cancer types with the highest number of reports overall.

Figure 1.Trend of reports linking cancers to microbiota 20082019. Credit: Graph generated using Elsevier Text Mining and Scopus.

With overall cancer rates set to increase worldwide, the current interest in the microbiome and its role in precision medicine is likely to continue because it offers new hope of treatments. Evidence suggests the importance of looking for predictors of therapeutic response beyond the tumor by focusing on host factors, such as microbiota and host genomics.1 Importantly, the microbiota is a modifiable factor, and potentially can become not just a predictive marker but also a potential target in order to improve outcomes for patients.

Progress is also being made in clinical trials looking at the microbiome and melanoma. Since 2018, four clinical trials that aim to study and modulate the gut microbiomes impact on response to immunotherapy of melanoma have been registered at clinicaltrials.gov. Dr Marc Hurlbert, Chief Science Officer for the Melanoma Research Alliance, commented on the findings: As noted in the report, there has been an explosion of knowledge about melanoma with an ever-increasing list of protein targets. Also noted, the role of the microbiome in melanoma and in response to immunotherapy is of increasing interest in the field.

To further develop targeted precision therapies, further research is now required. Firstly, to map genetic variants; secondly, to determine which variant is clinically significant; thirdly, to understand the impact of variant on gene function, and whether variation activates or inhibits the gene. This is particularly important for increased understanding of specific, precision medicine and to enhance therapeutic efficacy.

For non-hereditary (sporadic) melanoma, the analysis showed that there are 752 genes genetically linked to sporadic melanomas and its subtypes, and 449 genetic variants genetically linked to sporadic melanoma and its subtypes. Out of the 449 genetic variants, 395 are from 78 genes that are genetically linked to melanoma. The remaining missing 54 variants are not currently genetically linked in the platform to any known melanoma gene; this could therefore be a potential area for further research.

Understanding whether specific genetic variants exist and/or contribute to melanomas severity and prevalence in populations will help the research and development (R&D) industry to develop more effective and profitable therapeutics. These types of data will provide the R&D community with a greater depth of understanding and of the increased likelihood of hitting the target. Through our analysis we found an increased incidence of drugs targeting genetic mutations over the last decade, particularly targeting protein kinases and growth factor receptors.

It is an attractive future research avenue to recognize how a patients microorganisms genome, both symbiotic and pathogenic, can dramatically effect treatment plans and outcomes. Positively influencing the microbiome in patients needs further study that could lead to exciting opportunities for patients and for drug discovery. For the therapeutic pipeline it would be beneficial to understand these host-microbiota interactions and ways to positively tip the balance towards improving treatment outcomes.

One other interesting future consideration during drug development for all cancers is the influence of the microbiome on treatment-induced adverse events, and whether clinical and post-clinical adverse events are related to a patients microbial composition. It adds a level of complexity as to the efficacy of therapeutics that may not readily be considered, and potentially may be something to consider during future clinical trials.

Moreover, in the current COVID-19 era, in-person and patient interactions are reduced and many research labs are still unable to operate at full capacity. The ability to conduct research, take samples and study real patients is limited at present, so looking at detailed existing literature and data is a vital avenue to support R&D. It will keep R&D functions going and help them to direct efforts to the areas of greatest potential. 2021 will be a year of reduced R&D budgets globally this type of data insight will be vital to empowering future R&D.

Tom is the Life Sciences Group Manager of Project Management, Knowledge Manager, and Research Scientist. He has extensive experience as an academic researcher in neurodegeneration and Alzheimers disease. He is also skilled in biophysical chemistry, dementia disorders, and biochemistry. He is the author of many publications in the field of protein-membrane interactions, protein misfolding, and Alzheimers disease. At Elsevier he delivers and implements information solutions for customers.

Tom discusses the study and unmet needs in melanoma R&D in detail, here, alongside Marc Hurlbert, Ph.D. Chief Science Officer, Melanoma Research Alliance.

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Exploring the Relationship Between the Microbiome, Precision Medicine and Cancer - Technology Networks

Artificial Intelligence (AI) continues to evolve and to incorporate its way into our lives. Versions of AI now routinely tell Americans where to eat, what routes to take, and what movies to watch. Artificial Intelligence isalso making in-roads into medical decision-making, asdiagnosis and treatment recommendations become more personalized. That has raised concerns from some commentators, who have suggested that Americas tort law system could prove a problematic fit with medical AI. If jurors see the act of listening to the computer as something that deviates from a doctors judgment and standard of care, than machine-centered advice could increase or complicate medical liability risk.

Researchers (Price, Gehrke & Cohen, 2021) looked at that question of whether juror attitudes might be a barrier to reliance on medical AI. The article, How Much Can Potential Jurors Tell Us About Liability for Medical Artificial Intelligence? focused on the circumstances under which jurors would hold a physician liable for following or not following an AI recommendation. Testing the response of the juror-eligible population to four scenarios, they found that following the AI recommendation does not appear to create unique liability risks for the physician: The experiments suggest that the view of the jury pool is surprisingly favorable to the use of AI in precision medicine. As a result, they concluded thatcivil liability is unlikely to hinder the acceptance of medical AI, at least not based on fear that jurors will distrust it. In this post, Ill look at the research and its implications.

The Research: Doctors Arent More Liable if They Listen to AI

The research emerged in response to the fear that medical AI could be like the driverless car, with people thinking, I can see how that would work in theory but Im not ready for technology to be making those decisions.The attitude, termed algorithm aversion relates to the perceived loss oflocus of controlin deferring our judgments to technology, even when that technology might be more resistant to human error.

To test whether this applies to medical AI, the research team conducted anonline experiment with a representative sample of 2,000 American adults. Participants reacted to one of four scenarios in which an ovarian cancer patient is given recommendations from a medical AI system called Oncology-AI, that advice is either for standard or nonstandard care, and the physician either accepts or rejects the AI recommendation.

The results suggest that jurors tend to favorbothstandard treatment, as well as following the AI recommendation. However, the physicians judgment does not automatically trump the AI recommendation, and physicians may be judged more harshly for rejecting the advice of a state-of-the-art tool. That mattered even when the AI recommendation was nonstandard: If physicians receive a nonstandard AI recommendation, they do not necessarily make themselves safer from liability by rejecting it.

The bottom line is that, all other things being equal, doctors tend to reduce their liability by accepting, rather than rejecting, the advice from AI.

The Implication: It Is About Normalization

The main implication is that tort law doesnt impose as much of a barrier to medical AI as some have suggested. One reason for that might be the increasing normalization of AI technology. As the article discusses, jurors focus on what seems normal, and theyre encouraged to do that based on definitions of the standard of care: Jurors evaluate what the normal or average physician would do. So, if high technology tools are not surprising in a medical context, then the typical conventional physician should adhere to these tools.

That, of course, doesnt mean that an AI recommendation will be right every time, or that blindly following it is the way to reduce liability, but it does suggest that a plaintiffs theme focusing purely on substituted judgment (i.e. she surrendered her own medical choices and just let the machine chose)may not be successful. After all, doctors are expected to use the best technology, anddisregardingthat advice might be riskier in the long run. The authors predict As AI becomes more common, any tort law incentive to accept AI recommendations will only strengthen further.

The broader point is that jurors tend to look for what fits within the range of expected and normal actions. Even in non-AI related cases, physicians will have a strong incentive to teach the jury what is typical and to normalize the knowledge, choices, and actions of the defendant.

____________________

Price, W. N., Gerke, S., & Cohen, I. G. (2021). How Much Can Potential Jurors Tell Us About Liability for Medical Artificial Intelligence?. Journal of Nuclear Medicine, 62(1), 15-16.

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Consider the AI Influence on Medical Liability | Holland & Hart - Persuasion Strategies - JDSupra - JD Supra

CHARLOTTESVILLE, Va., Jan. 28, 2021 /PRNewswire/ --MicroGEM, a Virginia-based molecular diagnostics company, today announced its acquisition of Jump Start Manufacturing LLC (Jump Start), a New Hampshire-based engineering company with proven success in the biotech and pharmaceutical industry. The acquisition allows MicroGEM to rapidly scale production of its innovative Spitfire6830 SARS-CoV-2 testing system, a high-performance, PCR-based point-of-need saliva test.

In addition to its pilot-scale manufacturing facility in Charlottesville, MicroGEM announced it has established new large-scale production facilities in Ogden, Utah, and Hudson, New Hampshire, expanding its manufacturing in the U.S. with plans to create more than 500 jobs between both locations. The facilities, with more than 120,000 square feet combined, give MicroGEM the capability of producing 160,000 tests per day.

"We are proud to join forces with the talented Jump Start team to accelerate the production and deployment of our innovative Spitfire6830 SARS-CoV-2testing system," said MicroGEM CEO Jeff Chapman. "Bringing Jump Start's leading manufacturing capabilities and expertise under the MicroGEM umbrella and dramatically expanding our production capabilities will ensure that more Americans have greater access to high-quality COVID-19 tests bringing key tools to help end this devastating pandemic."

MicroGEM's Spitfire6830 system is designed to detect SARS-CoV-2 in both symptomatic and asymptomatic individuals. The system is in final stages of development with preparations underway for submission to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization.

"The unique capability of the Spitfire6830 to quickly provide highly sensitive and specific identification of SARS-CoV-2 from saliva samples puts MicroGEM at the cutting edge of point-of-need diagnostics," said Jump Start founder, Thomas Moran, who joins MicroGEM as Chief Operations Officer overseeing all manufacturing activities. "Jump Start is thrilled to join the MicroGEM team, enabling us to help bring this low-cost, high-quality test to market while ensuring our Jump Start customers continue to receive the high-touch service they expect and deserve."

MicroGEM's Spitfire project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx)initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00015.

About Jump Start

Based in Nashua, New Hampshire, Jump Start is an engineering company established in 2006 with a successful record managing product launches for a variety of biotech and pharmaceutical companies, with expertise in medical devices. Jump Start offers a full range of engineering solutions, including machine design, manufacturing engineering, and a mechanical engineering laboratory, quickly implementing manufacturing solutions and process improvements with 'concierge-style' service. Jump Start's manufacturing expertise includes complex projects such as self-heating products, high precision medical infusion systems, and drug delivery systems. Under the MicroGEM umbrella, Jump Start will continue to provide all existing services to its customers with no interruption while increasing its capacity to offer a wider breath of capabilities to its clients.

About MicroGEM

MicroGEM is democratizing molecular diagnostics by moving molecular techniques out of conventional, highly skilled laboratories to non-laboratory settings. The company's innovative enzymatic approach to nucleic acid extraction provides the foundation for rapid sample preparation suitable for PCR analysis. Coupled with MicroGEM's expertise in microfluidics and synthetic biology, the company is creating the next generation of rapid, point-of-need diagnostic solutions for the management of infectious diseases and other personalized medicine applications.

To learn more about job openings at MicroGEM, visit https://microgembio.com/jobs/.

Visit http://www.microgembio.com and connect with us on LinkedInand Twitter.

Contact: Liz Halloran[emailprotected] 202-253-2656

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MicroGEM Acquires Jump Start, Expands Manufacturing To Accelerate Production Of Portable COVID-19 Saliva Test - PRNewswire

Jan. 26, 2021 12:00 UTC

Funding Supports Aclipse Therapeutics and Sheffield Institute of Translational Neurosciences Development of M102 in Amyotrophic Lateral Sclerosis

RADNOR, Pa.--(BUSINESS WIRE)-- Aclipse Therapeutics (Aclipse or the Company), a private biopharmaceutical company, today announced that the Company and its collaborator, The Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield in the United Kingdom (UK), were awarded a drug development research grant of 1.6 million (approximately US $2.2 million) from the UKs Medical Research Council (MRC), one of the largest funders of medical research worldwide, to support the translational development of M102. M102 is Aclipses drug candidate for the treatment of amyotrophic lateral sclerosis (ALS), also referred to as motor neuron disease (MND) or Lou Gehrigs disease.

M102 is a potentially disease-modifying drug candidate that has shown promise to impede ALS disease progression in a wide array of preclinical models. Currently, there is no cure for ALS and there are no effective treatments to halt or slow the progression of the disease.

This development funding from MRC is wonderful news for ALS/MND patients who are in dire need of an effective therapy to address this life-threatening neurodegenerative disease, stated Professor Dame Pamela Shaw, M.D., Director of SITraN and a primary contributor to M102s development program. Along with my SITraN colleagues, Dr. Richard Mead and Dr. Laura Ferraiuolo, we spearheaded the ALS/MND biology research that led to the development of M102, including the discovery of a potential precision medicine approach for M102 in ALS/MND, so we are very appreciative of MRCs funding support.

Aclipse is taking a multiple biological pathway, multiple disease mechanism approach to ALS. M102 activates the NRF2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways, which are recently understood to impact ALS pathophysiology. M102 is expected to be mechanistically superior to currently available drugs and may lead to significant slowing of disease progression in both familial and sporadic ALS.

The MRC grant will also support the development of patient stratification biomarkers that will be applied in the M102 clinical studies, potentially enabling a personalized medicine approach in ALS. The goal of the patient stratification biomarkers is to identify M102 drug responders versus non-responders in order to target M102 to those ALS patients most likely to benefit from the drug.

We greatly appreciate the support from MRC for our novel and broad multi-disease patho-mechanism approach to treating ALS patients, said Raymond K. Houck, CEO of Aclipse Therapeutics. The MRC award, coupled with our recent FightMND grant award, accelerates M102s development into its first-in-human clinical studies and validates M102s biology and potential for a precision medicine approach for the treatment of ALS.

The research funding from these programs will be key as they will support the completion of our investigational new drug (IND)-enabling work and the regulatory filings for first-in-human studies. Importantly, M102 may have applications in a wide array of conditions associated with impaired neuronal function such as Friedreichs ataxia, Huntingtons disease and Parkinsons disease, added Mr. Houck.

About ALS/MND Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, is a progressive neurodegenerative disease that affects motor neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. There is no cure and limited life-prolonging treatments for the disease. Based on U.S. population studies, approximately 5,600 people in the U.S. are diagnosed with ALS each year and as many as 25,000 Americans have the disease at any given time.

About Medical Research Counsel The United Kingdoms Medical Research Counsels mission is to improve human health through world-class medical research. To achieve this, MRC supports research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. MRC works closely with the UKs National Health Service and the UK Health Departments to deliver its mission and give a high priority to research that is likely to make a real difference to clinical practice and the health of the population.

About the Sheffield Institute for Translational Neuroscience The Sheffield Institute for Translational Neuroscience (SITraN) is an international center of excellence recognized for its ground-breaking work in the fight against motor neurone disease and other common neurodegenerative disorders. SITraN brings together 300 staff and research students in multi-disciplinary teams with state-of-the-art laboratories and equipment to study neurological illness. The center is unique in its design to unite clinicians and multidisciplinary teams of scientists to translate discoveries in basic neuroscience into benefits for patients. The SITraN teams have developed a robust portfolio of in vitro and in vivo models to facilitate our understanding of disease mechanisms and identify new targets for therapeutic intervention which can be tested in our BRC experimental medicine programs.

The work of SITraN is a major pillar of the University of Sheffields cross-faculty Neuroscience Institute, one of four flagship research institutes launched in 2019 to tackle the biggest global challenges through pioneering real-world solutions and involving >120 principal investigators in the Faculties of Medicine, Science and Engineering.

About Aclipse Therapeutics Aclipse Therapeutics develops novel and differentiated drugs to treat orphan diseases with significant unmet medical needs. Our lead drug candidate, M102, is in development for the treatment of ALS with potential use in other neurodegenerative diseases such as Friedreichs ataxia, Huntington's disease and Parkinson's disease. M102 targets multiple disease pathomechanisms and enables a precision medicine approach for the identification of patients who are most likely to benefit from the drug. Aclipse has a very experienced orphan drug management team and a clinical advisory board of the top ALS physicians in the world. For more information about Aclipse, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

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Aclipse Therapeutics Announces $2.2 Million Grant from UK's Medical Research Council for Development of M102 - BioSpace

MINNEAPOLIS, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, announced today that its wholly owned subsidiary Soluble Biotech, Inc. just inked another contract with a large pharmaceutical company. The work will involve using Soluble Biotechs proprietary protein formulation technology to improve the solubility and stability of a protein therapeutic destined for future clinical use.

This opportunity may also lead to a long-term relationship whereby Soluble Biotech develops a strategic partnership to support several other therapeutics currently under development within the pharmaceutical company, said Dr. Larry DeLucas, Founder and President of Soluble Biotech, Inc.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement, and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins, and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward- looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:

Landon Capital Keith Pinder (404) 995-6671kpinder@landoncapital.net

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Soluble Biotech, a Wholly Owned Subsidiary of Predictive Oncology, Inked Contract with Large Pharmaceutical Company - GlobeNewswire

New York, Jan. 28, 2021 (GLOBE NEWSWIRE) -- The nutraceutical products market was valued at USD 270.96 Billion in the year 2019 and has been projected to rise at a CAGR of 7.1% from 2020 to 2027. Nutraceutical products are mainly a part of food that delivers several nutritional values to the diet. It is also considered as functional foods, containing pharmaceutical-grade and standardized nutrients. These supplements are the source of dietary supplements and work towards preventing diseases. People globally are becoming more inclined towards diverse food and beverage types, having added various nutritional supplements; thus, nutraceutical products are gaining traction.

Globally, various nutraceutical products are gaining immense popularity, becoming a part of the daily diet of consumers. The rising prevalence of various lifestyle diseases and the growing number of people taking numerous preventive healthcare measures are stimulating demand in the industry. Increasing utilization of a wide range of functional food and beverages by the young population is further augmenting the markets growth over the estimated era. High technological progress in the area of nutraceutical products is also contributing to the industrys development. A trend of personalized medicine is likely to trigger demand for nutraceutical products.Get FREE Sample Copy with TOC of the Report to understand the structure of the complete report@ https://www.reportsanddata.com/sample-enquiry-form/2421

The market for nutraceutical products is primarily fueled by factors such as rising awareness about health among the aging population, increasing costs of health care, diet-disease links, and fast advancements in nutrition and food technology. Currently, various health concerns, including cardiovascular disease, cholesterol reduction, and osteoporosis, are attractive targets for a range of nutraceutical products, followed by high blood pressure, menopause-related ailments, child development, diabetes, GI disorders, and lactose intolerance.

Further key findings from the report suggest

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Segments covered in the report:

This report forecasts revenue growth at global, regional & country levels, and provides an analysis of market trends in each segment and sub-segment from 2017 to 2027. For the purpose of this study, Reports and Data has segmented the nutraceutical products market on the basis of source, product, distribution channel, and region:

Source Outlook (Revenue, USD Million; 2017-2027)

Product Outlook (Revenue, USD Million; 2017-2027)

Distribution Channel Outlook (Revenue, USD Million; 2017-2027)

Click on the link to read key highlights of the report and look at projected trends for years to come: https://www.reportsanddata.com/report-detail/nutraceutical-products-market

Regional Outlook (Revenue, USD Million; 2017-2027)

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Digestive Health Products Market Size, Share & Analysis, By Ingredient (Prebiotics, Probiotics, Digestive Enzymes), By Product (Non-Alcoholic Beverages, Bakery & Cereals, Dairy), By Distribution Channel (Modern Trade, Convenience Stores, And Online Retailers) And Region, Forecast To 2027

Resistant Maltodextrin Market Size, Growth Trends & Analysis By Type (Corn-Based, Wheat-Based, Potato-Based, Others), By Application (Beverages, Bakery & Confectionery, Dairy Products, Nutraceuticals, Others), By Region, Forecast To 2027

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Nutraceutical Products Market Size To Reach USD 461.70 Bn By 2027 | Growing Demand for Fortified Food Owing to the Increasing Health Consciousness...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH). Despite guideline recommendations for comprehensive genomic profiling (CGP) of all patients with advanced non-small cell lung cancer (NSCLC), profiling remains suboptimal due to continued reliance on invasive tissue biopsies for testing. A new study published in JCO Precision Oncology confirms previously reported data showing that the Guardant360 liquid biopsy is not only concordant to tissue genotyping, but detects significantly more informative alterations when used prior to tissue testing, and achieves similar treatment response rates and progression-free survival in patients with NSCLC. Publication link here.

The prospective study1 (n=186) compares comprehensive genomic profiling using the Guardant360 liquid biopsy versus standard-of-care tissue genotyping for first-line treatment decisions in advanced NSCLC. Patients with advanced NSCLC received targeted therapies based on the actionable biomarkers identified. Compared to tissue biopsy genotyping at time of diagnoses, the Guardant360 liquid biopsy was not only concordant with tissue biopsy but detected 23.6 percent more informative mutations when used first and before tissue biopsy.

The study adds to the growing body of evidence2-4 demonstrating that using a blood-first approach using the Guardant360 test for genomic biomarker detection can identify more actionable biomarkers than a tissue-first approach. Importantly, objective response rates and progression-free survival in biomarker-positive patients receiving targeted therapy was similar to previously reported registrational trials.

Despite the ever-growing availability of life-changing targeted drugs for treating patients with advanced lung cancer, many continue to be treated with chemotherapy or immunotherapy because first-line treatments are made without conducting comprehensive genotyping first, said the Principal Investigator of this study Dr. Rafael Rossell, Chief Medical Officer and President of the Dr. Rosell Oncology Institute. This publication outlines further evidence that the Guardant Health liquid biopsy is very effective in uncovering actionable genomic alterations, overcomes the challenges of tissue biopsies, and helps clinicians more easily customize treatments to improve the prognosis and survival of their patients.

Numerous clinical studies show that patients receiving targeted or personalized treatments have improved progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.5-11 Various factors contribute to clinical adoption of personalized medicine lagging behind recommended medical guidelines, including insufficient tissue for biopsy, which is the case for as many as 30 percent of solid cancer patients.12-14

Once again, the data show that our blood-first approach using our Guardant360 liquid biopsy has the advantage of increasing the number of patients receiving potentially life-changing targeted treatments without compromising treatment efficacy, said Helmy Eltoukhy, Guardant Health CEO. Sadly, research indicates that approximately 80 percent of advanced lung cancer patients do not receive comprehensive genotyping before starting treatment. I hope that with the recent FDA approval of our Guardant360 CDx liquid biopsy test, more clinicians will feel confident making the shift to liquid biopsies so we can reverse the serious trend of undergenotyping that exists today.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360, Guardant360 CDx, and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Healths liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Healths financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operation and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019, in its Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020, respectively, and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Healths views as of any date subsequent to the date of this press release.

References

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Head-to-Head Study Shows Guardant360 Liquid Biopsy Outperforms Tissue Biopsy for Comprehensive Genomic Profiling in Advanced Non-Small Cell Lung...

DALLAS--(BUSINESS WIRE)--Perspectum announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Hepatica, a precision oncology decision support tool for liver cancer.

Each year, around 200,000 Americans are diagnosed with primary or secondary liver cancer, with surgery as one of the key treatment options. The success of surgery relies on the volume and health of the remaining liver, which is impacted by any underlying chronic liver disease (CLD). Fatty liver disease, chronic viral hepatitis B and C as well as alcoholic liver disease affect nearly 100 million Americans, with prevalence increasing. Accurate pre-surgical assessment of liver health is therefore urgently needed to improve the outcomes for patients.

Hepatica uses non-invasive quantitative multiparametric MRI to provide a liver health assessment based on AI-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat. Using AI to delineate the liver and calculate regional volumes saves over 20 minutes of pre-operative radiology time per case.

Initial results from UK-based study on 143 surgical candidates showed that by combining estimated future liver remnant with an assessment of underlying fibro-inflammation, Hepatica could effectively identify patients at risk of poor outcomes from surgery and a longer stay in hospital. This information enables tumour boards and multidisciplinary teams to make more informed pre-operative decisions to improve post-operative outcomes for patients, translating to cost-savings in associated care.

Mr Myrddin Rees, Consultant General and Hepatobiliary Surgeon at HHFT commented, As a hepato-biliary surgeon with over 30 years of experience operating on the liver I am thrilled that Hepatica is now cleared for clinical use. The missing element in all our current diagnostic, non-invasive imaging is an accurate assessment of the quality of the liver parenchyma. Hepatica provides the surgeon with a measure of liver well-being that allows us to push the boundaries on the one hand whilst avoiding the removal of inappropriate liver volume on the other. This work is a significant advance in our quest to treat more patients with liver disease whilst armed with the knowledge of what can be achieved safely.

Hepatica seamlessly integrates into the clinical workflow and provides a simple, patient-friendly report via a cloud-based service.

Hepatica is an advanced oncology tool that provides objective information to guide personalized clinical management, said Professor Claude Sirlin, Professor of Radiology at University of California, San Diego. It is an excellent application of smart imaging and Artificial Intelligence in medicine, and I look forward to seeing how it can be used in a variety of indications to improve clinical care.

Notes to Editors

About Hepatica

Hepatica is a precision oncology tool for clinical and surgical decision support tool based on non-invasive quantitative multiparametric MRI. It identifies high risk patients and enables more informed preoperative decision making, therefore improving post-operative outcomes. Hepatica has demonstrated utility in identifying patients at risk of poor outcomes, with the potential to inform surgical planning and realize significant cost savings through lowering the post-surgical complication rate, associated in-patient hospital stay and reducing time required from radiologists.

About Perspectum

Perspectum delivers cutting-edge digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.

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FDA Clearance for Hepatica, Perspectum's Surgical Decision Support Tool for Liver Cancer - Business Wire

Doxzen's two-year joint appointment is part of a cutting-edge collaboration between WEF's Centre for the Fourth Industrial Revolution (C4IR) in San Francisco and the two schools based on ASU's Downtown Phoenix campus. As a Hoffmann Fellow, Doxzen will lead transnational projects that explore and tackle global policy and governance challenges in healthcare driven by emerging biotechnologies such as gene editing and synthetic biology.

"We're thrilled to have Kevin in this high-impact role, which gives us an opportunity to re-imagine precision medicine by leveraging new biotech in developing countries in spite of low-resource challenges," said Thunderbird's Director General and Dean, Sanjeev Khagram.

"Kevin's experience and expertise in genome-editing research and policy position him to be a difference-maker on a global scale through this prestigious fellowship. Working with faculty, administrators, and professionals spanning the worldwide networks of Thunderbird, ASU Law, and WEF, he will advance scholarship and experimentation in an international community to create resilient, robust governance frameworks that guide emerging biotechnologies such as CRISPR for the benefit of humanity," said Khagram.

"ASU Law, through its Center for Law, Science and Innovation, and Thunderbird have a long history of working with WEF at the intersection of law, governance and emerging technologies," said ASU Law's Associate Dean for International Engagement Di Bowman. "Partnering with WEF's C4IR to host esteemed Hoffmann Fellows represents a new and exciting chapter in our collaboration and we are delighted to welcome Kevin as our first fellow."

"Global healthcare challenges depend on global solutions that harness scientific and technological advances from diverse sectors and disciplines," said Genya Dana, Head of Healthcare Transformation at the World Economic Forum. "We are excited to welcome Kevin to the Forum's C4IR to help us lead efforts to ensure that emerging biotechnologies support equitable and ethical health and healthcare advances. We look forward to this collaboration withleading-edge partners at ASU to design and pilot new business models, policies and collaborative approaches to supporting the translation of cutting-edge science into treating and even curing rare diseases, blood disorders, and cancers."

"The Coronavirus Pandemic and the new era of biotechnology associated with the Fourth Industrial Revolution that COVID-19 is accelerating highlight the vital importance of the work Kevin has already started," said Professor Landry Sign, search committee chair and Senior Director of Thunderbird's Fourth Industrial Revolution and Globalization 4.0 Center. "And as a Hoffmann Fellow at ASU, he'll continue tapping into a global spectrum of experts to advance both practice and policy in next-generation precision medicine, producing new knowledge and high-tech healthcare tools with real-world impact."

About Thunderbird School of Global ManagementThunderbird School of Global Management is a unit of the Arizona State University Enterprise. For 75 years, Thunderbird has been the vanguard of global management and leadership education, creating inclusive and sustainable prosperity worldwide by educating future-ready global leaders capable of tackling the world's greatest challenges. Thunderbird's Master of Global Management was ranked #1 in the world for 2019 by the Wall Street Journal/Times Higher Education. ASU is ranked No. 1 "Most Innovative School" in the nation by U.S. News & World Report for six years in succession. Thunderbird Executive Education has been ranked in the top 10 internationally for decades.

About the Sandra Day O'Connor College of LawThe Sandra Day O'Connor College of Law at Arizona State University is one of the nation's preeminent law schools, focused on offering students a personalized legal education. Ranked No. 1 in Arizona since 2010 and No. 24 nationally by U.S. News & World Report, ASU Law offers students the opportunity to tailor their education, to match externships to their interests and career services resources to help land their ideal jobs. Additionally, ASU Law's LEED Gold certified building in downtown Phoenix is steps away from the legal, political and economic heart of Arizona. For more information, visit law.asu.edu.

About ASUArizona State University has developed a new model for the American Research University, creating an institution that is committed to access, excellence, and impact. ASU measures itself by those it includes, not by those it excludes. As the prototype for a New American University, ASU pursues research that contributes to the public good, and ASU assumes major responsibility for the economic, social, and cultural vitality of the communities that surround it.

CONTACT:Jonathan Ward Thunderbird Media Relations[emailprotected]+1 480.490.9773Download Media

SOURCE Thunderbird School of Global Management

https://thunderbird.asu.edu/

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The Personalized Medicines Market grew in 2019, as compared to 2018, according to our report, Personalized Medicines Market is likely to have subdued growth in 2020 due to weak demand on account of reduced industry spending post Covid-19 outbreak. Further, Personalized Medicines Market will begin picking up momentum gradually from 2021 onwards and grow at a healthy CAGR between 2021-2025.

Deep analysis about Personalized Medicines Market status (2016-2019), competition pattern, advantages and disadvantages of products, industry development trends (2019-2025), regional industrial layout characteristics and macroeconomic policies, industrial policy has also been included. From raw materials to downstream buyers of this industry have been analysed scientifically. This report will help you to establish comprehensive overview of the Personalized Medicines Market

Get a Sample Copy of the Report at: https://i2iresearch.com/download-sample/?id=16521

The Personalized Medicines Market is analysed based on product types, major applications and key players

Key product type:PM DiagnosticsPM TherapeuticsPersonalized Medical CarePersonalized Nutrition & Wellness

Key applications:Hospitals PharmaciesRetail PharmaciesDietary Care CentersOthers

Key players or companies covered are:3G BiotechQuest DiagnosticsLaboratory Corporation of AmericaAbbottAgendia NVAsuragen IncBecton DickinsonCardioDx Inc.Foundation MedicineQiagenSiemens HealthcareAmgenBristol-Myers SquibbGE HealthcarePfizerSanofi23andMeIllumina

The report provides analysis & data at a regional level (North America, Europe, Asia Pacific, Middle East & Africa , Rest of the world) & Country level (13 key countries The U.S, Canada, Germany, France, UK, Italy, China, Japan, India, Middle East, Africa, South America)

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Key questions answered in the report:1. What is the current size of the Personalized Medicines Market, at a global, regional & country level?2. How is the market segmented, who are the key end user segments?3. What are the key drivers, challenges & trends that is likely to impact businesses in the Personalized Medicines Market?4. What is the likely market forecast & how will be Personalized Medicines Market impacted?5. What is the competitive landscape, who are the key players?6. What are some of the recent M&A, PE / VC deals that have happened in the Personalized Medicines Market?

The report also analysis the impact of COVID 19 based on a scenario-based modelling. This provides a clear view of how has COVID impacted the growth cycle & when is the likely recovery of the industry is expected to pre-covid levels.

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Personalized Medicines Market 2020- Applications, Challenges, Growth, Shares, Trends, Top Players and Forecast to 2026 with key players position (3G...

Dublin, Dec. 30, 2020 (GLOBE NEWSWIRE) -- The "Companion Diagnostics Market - Growth, Trends, and Forecasts (2020 - 2025)" report has been added to ResearchAndMarkets.com's offering.

The growth of the global companion diagnostics market can be attributed to the rising focus on personalized medicine and the co-development of drug and diagnostic technologies. Additionally, rising cases of adverse drug reactions related to drugs, due to the lack of efficacy, drive the need for companion diagnostics.

One of the major factors driving the growth of the companion diagnostics market is the increasing demand for personalized medicines and awareness about the same, among the population. With companies increasing their collaborations for better biomarkers and diagnostics, in order to focus on cost regulations, there has been a significant number of opportunities for its applications in indications, like cancer, cardiovascular, and neurological disorders.

Key Market Trends

Application in Lung Cancer is expected to Dominate the Market over the Forecast Period

Companion diagnostic tests (CDXs) are considered mandatory in decision-making for treatment with targeted therapies in lung cancer. The emergence of immunotherapy has also given rise to the development of CDXs. Therascreen EGFR RGQ PCR Kit (Qiagen) and Cobas EGFR Mutation Test v2 (Roche Molecular Systems) are some of the many companion diagnostics available for lung cancer therapies.

Moreover, lung cancer is the most common form of cancer, and causes most cancer-related deaths, globally, as per the 2018 report by the World Health Organization. This translates to more demand for lung cancer companion diagnostics, which is expected to help the market growth.

North America Captured the Largest Market Share and is Expected to Retain its Dominance

North America dominated the overall companion diagnostics market, with the United States emerging as the major contributor to the market. The use of companion diagnostics is considered as an important treatment decision tool for a number of oncology drugs, which is also reflected in the way the FDA classifies these assays, in relation to risk.

In the United States, companion diagnostic assays are classified as IVD class III products, which represents a high-risk category, and consequently, the highest level of regulatory control. Hence, owing to high healthcare technology adoption rates and increasing demand for personalized medicine, the US companion diagnostics market is expected to register a substantial growth rate, during the forecast period.

Competitive Landscape

The presence of major market players, such as Abbott Laboratories, Agilent Technologies Inc., F Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV, is increasing the overall competitive rivalry of the market studied.

However, the issues associated with the high development cost and poor reimbursement are affecting the market negatively. Moreover, the rising focus of companies toward personalized medicine, co-development activities, and increased cases of adverse drug reactions is expected to boost the competitive rivalry in the market studied.

Key Topics Covered:

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Companies Promoting Personalized Medicine and Targeted Therapy as a New Treatment Option4.2.2 Increasing Cases of Adverse Drug Reactions4.2.3 Co-development of Drug and Diagnostic Technology4.3 Market Restraints4.3.1 High Cost of Drug Development and Associated Clinical Trials4.3.2 Reimbursement Issues among Many Countries4.4 Industry Attractiveness - Porter's Five Forces Analysis

5 MARKET SEGMENTATION5.1 By Technology5.1.1 Immunohistochemistry (IHC)5.1.2 Polymerase Chain Reaction (PCR)5.1.3 In-situ Hybridization (ISH)5.1.4 Real-time PCR (RT-PCR)5.1.5 Gene Sequencing5.1.6 Other Technologies5.2 By Indication5.2.1 Lung Cancer5.2.2 Breast Cancer5.2.3 Colorectal Cancer5.2.4 Leukemia5.2.5 Melanoma5.2.6 Other Indications5.3 By Geography

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Abbott Laboratories6.1.2 Agilent Technologies Inc.6.1.3 F Hoffmann-La Roche Ltd6.1.4 Biomerieux SA6.1.5 Qiagen NV6.1.6 Siemens Healthcare6.1.7 Thermo Fisher Scientific Inc.6.1.8 Danaher Corporation (Beckman Coulter Inc.)

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Global Companion Diagnostics Market Growth, Trends, and Forecasts Report 2020-2025: Companies Promoting Personalized Medicine and Targeted Therapy as...

Dublin, Dec. 31, 2020 (GLOBE NEWSWIRE) -- The "Research Antibodies and Reagents Market by Product {Antibodies [Type (Primary, Secondary), Production, Source, Research Area (Oncology, Neurology)], Reagents}, Technology (ELISA, Western Blot), Application, End User (Pharma, Academia) - Global Forecast to 2027." report has been added to ResearchAndMarkets.com's offering.

The research antibodies and reagents market is expected to grow at a CAGR of 5.6% from 2020 to 2027 to reach USD 6.32 billion by 2027.

Factors such as rising demand for protein therapeutics & personalized medicine, increasing investment in stem cell research, and rising need for biomarker identification represent high-growth opportunities for players during the forecast period. However, factors such as high cost and time related to identifying and developing potential antibodies are expected to hinder the growth of this market.

In 2020, based on type, the antibodies segment is projected to account for the largest share of this market. The large share of this segment is mainly attributed to increasing demand for antibodies for biomedical research, growing focus on protein and cell-based research, and increasing number of biomarker discovery.

On the basis of technology, in 2020, the flow cytometry segment is poised to command the largest share of the research antibodies and reagents market. The raising biomedical research for better diagnosis and therapy, initiatives for rising biomarker discovery, and growing cell & molecular-based research are the factors driving this growth of this segment.

In 2020, the proteomics segment is expected to command the largest share of the research antibodies and reagents market. Growing focus on protein-based research and the rising need for effective drugs using various protein-based disease profiling are the factors driving the growth of this segment.

The pharmaceutical and biotechnology industry is widely adopting research antibodies and reagents for proteomics research and drug discovery and development.

An in-depth analysis of the geographical scenario of the research antibodies and reagents market provides detailed qualitative and quantitative insights for the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. In 2020, North America is estimated to command the largest share of the research antibodies and reagents market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

Key Topics Covered:

1. Introduction1.1. Market Ecosystem1.1.1. Research Antibodies and Reagents Market1.1.2. Research Antibodies and Reagents Market, by Product1.2. Currency and Limitations1.3. Key Stakeholders

2. Research Methodology2.1. Research Process2.1.1. Secondary Research2.1.2. Primary Research

3. Executive Summary

4. Market insights4.1. Introduction4.2. Market Dynamics4.2.1. Drivers4.2.1.1. Rising Proteomics and Genomics Research Studies4.2.1.2. Increase in the Funding for Research Activities4.2.1.3. Growing Industry-Academia Collaboration4.2.2. Restraint4.2.2.1. High Cost and Time Related to Identification and Development of Potential Antibodies4.2.3. Opportunities4.2.3.1. Rising Demand for Protein Therapeutics and Personalized Medicines4.2.3.2. Rising Investment and Focus on Stem-Cell Research4.2.3.3. Rising Need for New Biomarker Identification4.2.3.4. Significant Opportunities from Emerging Asia-Pacific and Latin-American Markets4.2.4. Challenges4.2.4.1. Issues Related to Quality and Stability of Research Antibodies4.2.4.2. Intense Pricing Pressure on Leading Players

5. Research Antibodies and Reagents Market, by Product5.1. Introduction5.2. Antibodies5.2.1. Antibodies Market, by Type5.2.1.1. Primary Antibodies5.2.1.2. Secondary Antibody5.2.2. Antibodies Market, by Production Type5.2.2.1. Monoclonal Antibody5.2.2.2. Polyclonal Antibody5.2.2.3. Antibody Fragments5.2.3. Antibody Market, by Source5.2.3.1. Mouse5.2.3.2. Rabbit5.2.3.3. Other Sources5.2.4. Antibodies Market, by Research Area5.2.4.1. Oncology5.2.4.2. Infectious Diseases5.2.4.3. Cardiovascular Disease5.2.4.4. Immunology5.2.4.5. Neurology5.2.4.6. Stem Cell Research5.2.4.7. Other Research Areas5.3. Reagents5.3.1. Sample Preparation Reagents5.3.1.1. Media and Serum5.3.1.2. Stains and Dyes5.3.1.3. Probes5.3.1.4. Buffers5.3.1.5. Solvents5.3.2. Antibody Production Reagents5.3.2.1. Enzymes5.3.2.2. Proteins5.3.3. Other Research Reagents

6. Research Antibodies and Reagents Market, by Technology6.1. Introduction6.2. Flow Cytometry6.3. Immunofluorescence6.4. Enzyme-Linked Immunosorbent Assay6.5. Immunoprecipitation (IP)6.6. Multiplex Immunosorbent Assay6.7. Immunohistochemistry6.8. Western Blot6.9. Other Technologies

7. Research Antibodies and Reagents Market, by Application7.1. Introduction7.2. Proteomics7.3. Drug Discovery and Development7.4. Genomics

8. Research Antibodies and Reagents Market, by End User8.1. Introduction8.2. Pharmaceutical and Biotechnology Industry8.3. Academic and Research Institutes8.4. Contract Research Organizations

9. Research Antibodies and Reagents Market, by Geography

10. Competitive Landscape10.1. Introduction10.2. Key Growth Strategies10.3. Competitive Benchmarking10.4. Market Share Analysis

11. Company Profiles11.1. Business Overview11.2. Financial Overview11.3. Product Portfolio

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Global Research Antibodies and Reagents Market Report 2020-2027: Significant Opportunities from Emerging Asia-Pacific and Latin-American Markets -...