Clovis Oncology
FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies
FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.
Clovis, Myriad Genetics Working to Meet Post-Market Study Commitment for PARP Inhibitor
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
FDA clearance of the first NGS companion diagnostic paves the way for other comprehensive genomic profiling tests, but Foundation will have to educate docs on the benefits of its test.
Foundation BRCA CDx is First NGS Companion Test to Get FDA Nod
The test is approved to identify patients who harbor BRCA mutations and are therefore more likely to respond to Clovis Oncology's ovarian cancer drug Rubraca.