Myriad RBM DiscoveryMAP(R) Technology Identifies Novel Biomarkers That May Predict Increased Risk of Cardiovascular Events in Patients With Diabetes

Protein Biomarkers May Accelerate the Future of Personalized Medicine for CV Disease


SALT LAKE CITY, Nov. 16, 2015 (GLOBE NEWSWIRE) -- Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that its DiscoveryMAP® platform successfully identified combinations of 15 protein biomarkers associated with cardiovascular (CV) events or death in people with pre-diabetes or early type 2 diabetes, according to a study published by the journal Circulation.

"Cardiovascular diseases are one of the leading causes of deaths globally," said Riccardo Perfetti, M.D., vice president Medical Affairs, Global Diabetes at Sanofi, which sponsored the study. "We are optimistic that as we move toward personalized medicine, cardiovascular biomarkers will help us predict future events and possibly develop tailored treatment plans for patients that will save more lives."

In the paper titled, "Identifying Novel Biomarkers for Cardiovascular Events or Death in People with Dysglycemia," researchers at the Population Health Research Institute and Sanofi used Myriad RBM's DiscoveryMAP platform to evaluate 237 cardiometabolic biomarkers in serum from 8,401 participants in the completed Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial. Results of the assays were analyzed to identify biomarkers that provided better estimates of the risk of future CV events or death than could be estimated from standard clinical and biochemical data alone. The analysis identified a novel combination of 10 biomarkers that, when added to clinical risk factors, can find people with dysglycemia who are at higher risk of heart attack, stroke or CV death. Moreover, these 10 biomarkers, plus an additional five, had the greatest impact on the ability to predict death.   

"Our study is one of the largest scientific investigations in history to identify specific cardiovascular biomarkers associated with serious cardiovascular outcomes, including heart attacks, strokes and death," said Hertzel Gerstein, M.D., lead study investigator and deputy director, Population Health Research Institute. "Our results highlight the potential value of cardiovascular biomarkers for identifying people with dysglycemia at the highest risk of future events."

DiscoveryMAP is a comprehensive, quantitative, immunoassay service product that measures more than 300 human proteins. It is the culmination of 15 years of assay development for cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, cancer markers, kidney damage markers, CNS biomarkers and other important circulating proteins. 

"This is another demonstration that our DiscoveryMAP technology can successfully identify panels of biomarkers with important diagnostic and prognostic applications.  We believe that the protein biomarkers characterized by the PHRI and Sanofi teams may identify people at higher risk for cardiovascular events," said Ralph McDade, Ph.D., president of Myriad RBM. "Based on these very encouraging findings, we are pursuing additional research collaborations to further develop panels of protein biomarkers with application for cardiometabolic disorders."

About ORIGIN

ORIGIN (Outcome Reduction with Initial Glargine Intervention) was a seven-year landmark cardiovascular outcomes trial, evaluating insulin glargine versus standard care in over 12,500 individuals who were at high CV risk with pre-diabetes or early type 2 diabetes mellitus. ORIGIN was sponsored by Sanofi and was designed, conducted, and analyzed by the Population Health Research Institute and its international network of diabetes and cardiovascular disease experts.

About Human DiscoveryMAP®

DiscoveryMAP is for those who seek a thorough understanding of a compound's biological activity, efficacy and safety profile as well as the disease or condition being addressed. The DiscoveryMAP service products help increase the odds of identifying novel protein biomarker patterns in drug development or diagnostic discovery projects. These data can support critical go/no-go decisions or identify candidate panels for potential companion diagnostics. Once a pattern is discovered, it can be seamlessly converted into a CustomMAP for high volume sample processing resulting in better, more efficient clinical trials. For more information visit: http://rbm.myriad.com/discoverymap/

About Myriad RBM

Myriad RBM is a wholly owned subsidiary of Myriad Genetics, Inc. Myriad RBM's biomarker discovery platform provides clinical researchers and healthcare providers with reproducible, quantitative, multiplexed data for hundreds of proteins to advance drug development and patient care. The Company's proprietary Multi Analyte Profiling (MAP) technology offers preclinical and clinical researchers with broad, cost-effective analyses of multiple proteins from a single, small sample volume. MAP technology also supports Myriad RBM's drive to develop companion diagnostics in areas of unmet medical need such as neuropsychiatry, nephrology and immunology. More information about Myriad RBM can be found at www.myriadrbm.com.

About Myriad Genetics

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, Myriad myRisk, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris, and DiscoveryMAP are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to Myriad RBM's DiscoveryMAP® technology identifying novel biomarkers that may predict increased risk of cardiovascular events in patients with diabetes and other cardiovascular applications; and the Company's strategic directives under the captions "About Human DiscoveryMAP," "About Myriad RBM" and "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers' reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2015, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.



            

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