Myriad filed the first PMA module with the FDA, though based on the agency's feedback it's unclear whether it will view myChoice HRD as a companion or complementary test.
Roche's Cobas EGFR v2 mutation test will be able to identify advanced NSCLC patients with EGFR mutations who are likely to benefit from the next-generation treatment.
The non-small cell lung cancer drug now has two FDA-approved companion tests, Abbott's FISH test and Ventana's IHC test, for identifying patients most likely to benefit from treatment.
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.
