The agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.
There was a lot of growth in the precision medicine field in the past year, and some experts believe the FDA's decision to hold off on regulating LDTs could spur more innovation.
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.
The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.