Myriad Genetics Receives Expanded Coverage in Japan for Use of BRACAnalysis® Diagnostic System as a Companion Diagnostic for Lynparza® in Early-Stage Breast Cancer
Myriad Genetics announced that Japan’s Ministry of Health, Labour and Welfare has expanded coverage for its BRACAnalysis Diagnostic System to identify patients with germline BRCA-mutated and HER2-negative high-risk recurrent breast cancer. This coverage enables more patients in Japan to access BRCA1/2 testing, enhancing treatment decisions. The BRACAnalysis test is instrumental in guiding treatment options based on Phase III trial data demonstrating significant improvements in invasive disease-free survival for patients using Lynparza.
- Expanded coverage for BRACAnalysis Diagnostic System in Japan, increasing patient access.
- BRACAnalysis shows effective outcomes in guiding treatment for BRCA-mutated breast cancer patients.
- Data from OlympiA trial supports significant improvement in invasive disease-free survival with Lynparza.
- None.
SALT LAKE CITY, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted expanded coverage for the use of Myriad’s BRACAnalysis® Diagnostic System as a companion diagnostic to identify patients with germline BRCA-mutated (gBRCAm) and HER2-negative high-risk recurrent breast cancer who may benefit from Lynparza®(olaparib).
“This most recent coverage expansion 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 Phase III trial and numerous other clinical studies continue to demonstrate the power of BRACAnalysis as an effective test for patients deciding on their best treatment options.”
BRACAnalysis Diagnostic System is designed 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, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death.
“With this expanded coverage, more patients with breast cancer now qualify for BRCA1/2 testing in Japan,” said Shunsuke Kuraoka, Japan Country Manager, Myriad Genetics G.K. “BRACAnalysis Diagnostic System reflects our commitment to improving health outcomes and making it easier for patients and their providers to access important genetic insights to inform treatment decisions.”
Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/NASDAQ: AZN) and MSD Inc. The collaboration between Myriad Genetics and AstraZeneca on olaparib began in 2007. The partnership has resulted in multiple approvals in the U.S. and Japan, expanding the indication across multiple cancer types and stages of treatment.
The OlympiA Phase III trial was led by the Breast International Group in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, the U.S. National Cancer Institute, AstraZeneca and MSD.
About BRACAnalysis® Diagnostic System
BRACAnalysis is a diagnostic system that classifies a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. Variants are classified into one of 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 in Japan for determining diagnostic and therapeutic patient management decisions.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where 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. © 2022 Myriad Genetics, Inc. All rights reserved.
Lynparza is a registered trademark of AstraZeneca AB Corporation in the United States and foreign countries. Used with permission.
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 benefits of using biomarkers to guide care for patients, the BRACAnalysis Diagnostic System is designed to detect and interpret BRCA1 and BRCA2 variants, the BRACAnalysis CDx test identifies deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer, and the company’s commitment to improving health outcomes and making it easier for patients and their providers to access important genetics insights to inform treatment decisions. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to a number of known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such risks and uncertainties are described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed 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. Myriad disclaims any obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise except as required by law.
| Media Contact: Megan Manzari (385) 318-3718 Megan.Manzari@myriad.com | Investor Contact: Foster Harris (385) 350-8015 Foster.Harris@myriad.com |
FAQ
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