Home / FDA News / FDA Approves Myriad’s BRACAnalysis CDx as Companion Diagnostic for Lynparza in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer

FDA Approves Myriad’s BRACAnalysis CDx as Companion Diagnostic for Lynparza in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer

SALT LAKE CITY, Dec. 19, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved BRACAnalysis CDx® to be used by healthcare professionals to identify patients with advanced ovarian cancer who have a germline BRCAmutation (gBRCAm) and are eligible for first-line maintenance therapy with AstraZeneca’s PARP (poly ADP ribose polymerase) inhibitor, Lynparza® (olaparib) following response to platinum-based chemotherapy.  

“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCAm advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population,” said Lloyd Sanders, president, Myriad Oncology.  “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.”

The FDA approvals are based on results from the SOLO-1 trial (ClinicalTrials.gov number: NCT01844986) that tested Lynparza tablets as a maintenance treatment for patients with, advanced-stage BRCAm ovarian cancer who experienced a complete or partial response following first-line standard platinum-based chemotherapy.  The study results were published in the New England Journal of Medicine, and the key finding was that Lynparza maintenance therapy cut risk of disease progression or death by 70 percent.  

“In the SOLO1 trial, Myriad’s BRACAnalysis CDx test identified patients with advanced ovarian cancer who may benefit from Lynparza,” said Johnathan Lancaster, M.D., Ph.D., gynecologic-oncologist and chief medical officer, Myriad Genetics.  “The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis so they can fully understand their treatment options.”

Lynparza is being commercialized by AstraZeneca and Merck & Co., Inc. (known as MSD outside the US and Canada).  The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx. 

  • December 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients newly diagnosed with advanced ovarian cancer who are eligible for first-line maintenance treatment with olaparib. 
  • March 2018: The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
  • January 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib. 
  • August 2017: FDA approved BRACAnalysis CDx as a complementary diagnostic to identify patients with ovarian cancer who are eligible for second-line treatment with olaparib. 
  • Dec. 2014: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. 

About BRACAnalysis CDx®

BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA.  Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing.  Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.  This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.  Learn more at: http://myriadmychoice.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 five strategic imperatives:  build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020.  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, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris, ForeSight and Prelude 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.

Lynparza® is a registered trademark of AstraZeneca.

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