Myriad Genetics Receives FDA Approval of BRACAnalysis® CDx as a Companion Diagnostic for Lynparza® in Early Breast Cancer
BRACAnalysis CDx is now the only germline test approved by FDA as a companion diagnostic for treatment of HER2 negative high-risk early-stage breast cancer
SALT LAKE CITY, March 11, 2022 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the U.S. Food and Drug Administration (FDA) has approved Myriad’s BRACAnalysis® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) HER2 negative, high-risk early-stage breast cancer who may benefit from Lynparza®(olaparib).
“This most recent regulatory approval confirms the benefits of using biomarkers to help guide care for patients with breast cancer,” said Nicole Lambert, chief operating officer, Myriad Genetics. “Data from the OlympiA trial and numerous other clinical studies continue to demonstrate the power of BRACAnalysis CDx as an effective test for patients deciding on their best treatment options. More patients with breast cancer now potentially qualify for BRCA testing.”
BRACAnalysis CDx is intended to detect and interpret germline BRCA1 and BRCA2 variants. The test identifies deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer. In the OlympiA trial, patients with HER2 negative early-stage breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants, and high-risk clinicopathological factors had a statistically-significant and clinically meaningful improvement with longer survival, free of invasive or distant disease.
“Studies have demonstrated that PARP inhibitors are highly effective in patients with BRCA1/BRCA2 mutations. Once we identify these patients, they will have more options for treatment,” said Thomas Slavin, M.D., chief medical officer, Myriad Genetics. “This important advancement underscores the need for breast cancer patients being evaluated for approved therapies to know their BRCA status with an FDA-approved test right after diagnosis to help ensure they will receive the best available therapy. Additionally, the quick adoption of OlympiA criteria by guideline committees greatly supports the advancement of genomics in clinical care.”
Lynparza is being commercialized by AstraZeneca and MSD Inc. (MSD: known as Merck & Co., Inc. inside the US and Canada). The collaboration between Myriad Genetics and AstraZeneca on olaparib began in 2007 and has resulted in previous FDA approvals of BRACAnalysis CDx for patients with ovarian cancer on December 19, 2014, for patients with HER2 negative metastatic breast cancer on January 12, 2018.
The OlympiA Phase III trial is led by the Breast International Group in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, the US National Cancer Institute, AstraZeneca and MSD.
About BRACAnalysis® CDx
BRACAnalysis is a companion diagnostic test that classifies a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. Variants are classified into one of the five categories; “Deleterious,” “Suspected Deleterious,” “Variant of Uncertain Significance,” “Favor Polymorphism,” or “Polymorphism.” Once the classification is completed, the results are sent to medical personnel for determining the eligibility of patients for treatment with Lynparza. For full intended use, please see: https://myriad-oncology.com/bracanalysiscdx/.
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, ColarisAP, MyRisk, Myriad myRisk, MyRisk Hereditary Cancer, myChoice, Tumor BRACAnalysis CDx, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Precise, Health.Illuminated., RiskScore, Prolaris, GeneSight, FirstGene and EndoPredict are registered trademarks or trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries.
Lynparza is a registered trademark of AstraZeneca AB Corporation in the United States and foreign countries. Used with permission.
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 Myriad’s position as a leader in genetic testing and precision medicine, the benefits of using biomarkers to guide care for patients, Myriad’s identification of deleterious or suspected deleterious germline BRCA variants, the effectiveness of PARP inhibitors in patients with BRCA1/BRCA2 mutations and the advancement of genomics in clinical care. 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 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 or acquires; risks related to the company’s projections about the potential market opportunity for the company’s 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; and other factors discussed under the heading “Risk Factors” contained in Item 1A of the company’s Transition Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2021, 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.