NEW YORK (GenomeWeb News) ─ Myriad Genetics has submitted to the US Food and Drug Administration the first module of its premarket approval application for BRACAnalysis as a companion test for AstraZeneca's breast cancer PARP inhibitor olaparib.
The test is being used in two Phase III trials to pick out ovarian cancer patients who harbor BRCA mutations and as such are thought to be best responders to olaparib. Myriad filed an investigational device exemption application with the FDA less than a year ago to enable it to use BRACAnalysis as part of these studies. According to Myriad, the company has submitted the first of four PMA modules to date.
"BRACAnalysis is one of the first laboratory developed tests submitted for FDA premarket approval," Mark Capone, president of Myriad Genetics Laboratories, said in a statement.
Myriad and AstraZeneca's partnership to develop BRACAnalysis as a companion test for olaparib began in 2007. Last year, the firms expanded their collaboration, and Myriad announced it would build a new laboratory at its Salt Lake City headquarters to develop companion diagnostics in line with FDA regulations.
Before olaparib makes its way through the US regulatory process, the drug may first come to market in Europe. The European Medicines Agency accepted AstraZeneca's marketing application for olaparib last September, and the firm expects to hear from regulators there in 2015. A positive review of the drug would necessitate the simultaneous market launch of olaparib and the BRACAnalysis companion test.