Myriad Submits BRACAnalysis® CDx Application for Regulatory Approval in Japan for HER2- Metastatic Breast Cancer

On October 24, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients (Press release, Myriad Genetics, OCT 24, 2017, View Source [SID1234521116]).

“This regulatory submission as a companion diagnostic for a PARP inhibitor outside the United States reflects another important major milestone as Myriad seeks to become a global leader in personalized medicine,” said Mark C. Capone, president and chief executive officer, Myriad Genetics. “We believe there is broad applicability across all healthcare systems for our suite of companion diagnostics tests to improve the quality of care and lower healthcare costs.”

Myriad estimates there are greater than 10,000 cases of HER2- metastatic breast cancer per year in Japan which would be eligible for testing with BRACAnalysis CDx. Myriad will support testing in the Japanese market through its United States FDA approved laboratory.