Company launches Precise™ Tumor test, part of a comprehensive suite combining germline, tumor and companion diagnostics in one easy-to-access solution
SALT LAKE CITY, March 14, 2022 (GLOBE NEWSWIRE) –– Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the launch of Precise™ Oncology Solutions, a comprehensive offering designed to help oncologists determine effective and personalized treatment plans for individual patients. The new suite provides physicians with streamlined testing that combines germline testing, tumor profiling and companion diagnostic options including evaluation for Homologous Recombination Deficiency (HRD), an important cancer repair pathway.
Precise Oncology Solutions includes Myriad’s new Precise™ Tumor Molecular Profile Test, developed in collaboration with Intermountain Precision Genomics, leading healthcare providers, and industry partners. In pairing the tumor test with Myriad’s MyRisk™ Hereditary Cancer Test and its two companion diagnostic tests, MyChoice® CDx and BRACAnalysis® CDx, Myriad offers a testing combination that provides integrated genetic insights and makes it easier to tailor therapy and clinical trial selection. Precise Oncology Solutions is currently available for patients with solid cancer tumors.
“The ability to receive comprehensive results from Myriad for both germline testing and tumor profiling, including companion diagnostics, is a long-awaited and much-needed innovation for patients fighting ovarian cancer,” said Bradley Monk, M.D, FACOG, FACS, Biltmore Cancer Center and Professor of Gynecologic Oncology at the University of Arizona, Phoenix. “The information gathered from each of these tests are critical elements to help navigate each patient’s unique cancer treatment path.”
“Every patient deserves the most comprehensive assessment and cancer treatment available. Myriad’s new Precise offering is a significant step that brings us closer to achieving that goal,” said Lincoln Nadauld, M.D., Ph.D., Vice President, Chief of Precision Health and Academics, Intermountain Healthcare. “The combination of germline, somatic and companion testing allows doctors to be maximally informed to determine a personalized treatment plan that delivers the right medicine for the right patient at the right time.”
Precise Oncology Solutions includes Myriad’s two companion diagnostic tests. MyChoice CDx, which is FDA approved for patients with ovarian cancer, examines ovarian cancer tumors using BRCA1/2 mutation and genomic instability to determine a patient’s HRD status and resulting eligibility for targeted therapy. BRACAnalysis CDx identifies patients with a germline BRCA1/2 mutation and helps identify targeted treatment recommendations for patients with breast, ovarian, pancreatic and prostate cancers.
As part of this offering, healthcare providers can now place a single order for multiple Myriad tests and receive timely results through a new unified online portal. The portal serves as a central hub for providers to access the status of testing and easy-to-interpret summary findings. The results of each test are reported as completed and key findings are shared on a single summary page. Clinically significant discrepancies between individual reports are flagged and rectified to help physicians more easily interpret findings and develop care plans.
“Advancing precision oncology requires oncologists to be equipped with a thorough, timely set of data-driven answers to guide treatment decisions for patients with cancer. They need simpler, more comprehensive information to help manage disease at the very start,” said Faith Zaslavsky, President of Oncology, Myriad Genetics. “The Precise suite of solutions reflects our commitment to improving health outcomes for all and making it easier to access genetic insights.”
Myriad is also introducing a new Precise Treatment Registry that combines germline, somatic and HRD genetic data with patient outcomes to accelerate the pace of precision cancer research and equitable advancements in patient care. The registry is powered by DNAnexus’ secure, cloud bioinformatics platform for scientific data analysis, collaboration and discovery. The registry will enable clinicians to explore hypotheses in real-time by analyzing diverse de-identified patient data involving ancestry, geography, cancer diagnosis, treatment outcomes, and more.
Over the next few years, Myriad plans to further expand its oncology portfolio into liquid biopsy applications, including Minimal Residual Disease (MRD) detection. These offerings will be based on the company’s scientific platforms and capabilities as well as potential industry partnerships with other healthcare innovators.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. Fast Company named Myriad among the World’s Most Innovative Companies for 2022. For more information, visit www.myriad.com.
Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, Colaris AP, MyRisk, Myriad MyRisk, MyRisk Hereditary Cancer, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Precise, FirstGene, Health.Illuminated., RiskScore, Prolaris, GeneSight, and EndoPredict are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries.
Safe Harbor Statement 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 the Precise Treatment Registry enabling clinicians to explore hypotheses in real time by analyzing diverse de-identified patient data, the company’s plans to develop liquid biopsy applications, including MRD detection, the expectation that these offerings will be based on the company’s scientific platforms and capabilities as well as industry partnerships, and the company’s strategic imperatives under the caption “About Myriad Genetics.” These “forward-looking statements” are management’s present 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 described in the forward-looking statements. These risks include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on the company’s operations and the demand for its products and services; risks related to the company’s ability to efficiently and flexibly manage its business amid uncertainties associated with COVID-19; the risk that sales and profit margins of the company’s existing molecular diagnostic tests may decline or that the company may not be able to operate its business on a profitable basis; risks related to the company’s ability to generate sufficient revenue from its existing product portfolio or in launching and commercializing new tests; risks related to changes in governmental or private insurers’ coverage and reimbursement levels for the company’s tests or the company’s ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests and services; the risk that the company may be unable to develop or achieve commercial success for additional molecular diagnostic tests in a timely manner, or at all; the risk that the company may not successfully develop new markets for its molecular diagnostic tests, including the company’s ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying the company’s molecular diagnostic tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating and constructing the company’s laboratory testing facilities; risks related to public concern over genetic testing in general or the company’s 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 the company’s ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to the company’s ability to successfully integrate and derive benefits from any technologies or businesses that it licenses, acquires, or develops; risks related to the company’s projections about the potential market opportunity for the company’s current and future products; the risk that the company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the company’s tests; the risk of patent-infringement claims or challenges to the validity of the company’s patents; risks related to changes in intellectual property laws covering the company’s molecular diagnostic tests, or patents or enforcement, in the United States and foreign countries; risks related to security breaches, loss of data and other disruptions, including from cyberattacks; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that the company may be unable to comply with financial operating covenants under the company’s credit or lending agreements; risks related to the material weaknesses related to the company’s quarterly income tax provision process and general information technology controls, including the impact thereof and the company’s remediation plan, and its ability to achieve and maintain effective disclosure controls and procedures and internal control over financial reporting; risks related to current and future lawsuits, including product or professional liability claims; and other factors discussed under the heading “Risk Factors” contained in Item 1A of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2022, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
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