Myriad RBM Launches New Immunoassay Services Based on the Ultrasensitive Simoa(TM) Platform


SALT LAKE CITY, March 5, 2015 (GLOBE NEWSWIRE) -- Myriad RBM, a wholly owned subsidiary of Myriad Genetics, Inc., (Nasdaq:MYGN) today announced the launch of immunoassay services based on the ultrasensitive Simoa™ (single molecule array) platform developed by Quanterix. The Simoa platform enables the accurate measurement of protein biomarkers that were previously difficult or even impossible to detect in blood samples.

"The Simoa platform is an exciting new tool that is 100 to 1,000 times more sensitive than conventional tests for blood-based protein biomarkers and will open up new avenues of clinical research," said Ralph McDade, president of Myriad RBM. "We believe Simoa will significantly accelerate biomedical discoveries by providing researchers with valuable insights into both the underlying mechanisms of disease and the safety and efficacy of pharmaceuticals."

Initially, Myriad RBM will offer Simoa assay services for the study of inflammatory and autoimmune diseases. The Company has manufactured and validated Simoa-based quantitative immunoassays for interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha) that are available from its CLIA-certified laboratory in Austin, Texas. Each assay includes carefully designed calibrators and controls to provide multiple measurements of quality, precision and accuracy. Myriad RBM plans to add more Simoa-based immunoassays throughout the year.

The Simoa platform adds to Myriad RBM's long-standing track record of scientific excellence and commitment to providing high quality immunoassay research services. For more than 13 years, the Company has been a leading provider of multiplex immunoassay testing services to the biopharmaceutical industry and has earned a reputation for quality, a broad menu of assays and exceptional customer service.

"Understanding the incredible role of quantifying ultra-low concentrations of protein biomarkers in human blood samples and their linkage to the complex mechanisms of a disease has the potential to revolutionize the field of medicine as we know it," said Kevin Hrusovsky, executive chairman of Quanterix. "We are very pleased to be collaborating with Myriad RBM and to be working together to provide access to these important new developments in healthcare."

The Quanterix Simoa technology has been available to researchers since early 2014 following the successful validation of the tool's ability to measure multiple proteins simultaneously at the single molecule level using its novel technology. The unprecedented sensitivity of Simoa is the result of digital counting of chemical binding events that occur based on standard immunoassay chemistry.

About Simoa™

The Simoa platform uses single molecule measurements to access previously undetectable proteins. With this unprecedented sensitivity and full automation, Simoa offers significant benefits to both research and clinical testing applications. Simoa is a trademark of Quanterix.

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 is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions, and assess risk of disease progression and recurrence. Myriad is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand internationally. 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, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. 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 relating to Myriad RBM's launch of immunoassay services based on the Simoa™ (single molecule array) platform developed by Quanterix; the sensitivity of the Simoa platform versus conventional tests for blood-based protein biomarkers; the initial offering of the Simoa assay services for the study of inflammatory and autoimmune diseases; our belief that the Simoa platform will significantly accelerate biomedical discoveries by providing researchers with valuable insights into both the underlying mechanisms of disease and the safety and efficacy of pharmaceuticals; and the Company's strategic directives under the caption "About Myriad Genetics." 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 or will not continue to increase at historical rates; risks related to our ability to transition from our existing to new testing services, including unexpected costs and delays; risks related to changes in the 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; risks related to public concern over our 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 Annual Report on Form 10-K for the fiscal year ended June 30, 2014, 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.



            

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