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Japanese Regulators Approve Myriad Genetics' BRACAnalysis Test

NEW YORK (GenomeWeb) – The Japanese Ministry of Health, Labor, and Welfare has granted manufacturing and marketing approval for Myriad Genetics' BRACAnalysis Diagnostic System.

The test is approved as a companion diagnostic that can determine which metastatic, inoperable, or recurrent breast cancer patients have BRCA1 and BRCA2 genetic mutations, and therefore will likely to respond to the PARP inhibitor Lynparza (olaparib). Myriad will partner with Miraca Group subsidiary SRL, a large laboratory services provider in Japan, to commercialize BRACAnalysis in the country.

AstraZeneca and Merck are seeking approval of Lynparza in Japan for treating patients with BRCA-mutated metastatic breast cancer. Myriad announced it had submitted the BRACAnalysis for review by Japanese regulators in October 2017. 

Myriad estimated that approximately 40,000 patients in Japan with metastatic disease and 15,000 new cases of HER2-negative breast cancer annually would be eligible for assessment by its test.

The test, marketed as BRCAnalysis CDx in the US, received premarket approval from the US Food and Drug Administration in 2014 as a test that can identify which advanced ovarian cancer patient (previously treated with three or more lines of chemotherapy) will respond to Lynparza. Earlier this year, the FDA simultaneously expanded Lynparza's indication as a treatment for metastatic breast cancer patients who have BRCA-mutated tumors and BRACAnalysis CDx's indication as a test to identify best responders.