Myriad Genetics (NASDAQ:MYGN) submits an application in Japan seeking approval to market BRACAnalysis CDx there as a companion diagnostic to AstraZeneca's (NYSE:AZN) LYNPARZA (olaparib) for patients with HER2-negative metastatic breast cancer.
BRACAnalysis CDx is an in vitro diagnostic test that detects and classifies variants of BRCA1 and BRCA2 genes using genomic DNA from whole blood specimens. The FDA approved it in December 2014 as a companion diagnostic for LYNPARZA for ovarian cancer.
The company's U.S. application for breast cancer, submitted earlier this month, is under FDA review.
Previously: Myriad and AstraZeneca expand companion diagnostic partnership (April 1, 2015)