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.
By outlining a framework for advancing a drug and test together, the agency said it hopes to encourage innovations in precision medicine.
The results showed some concordance between different assays, but also significant enough differences to prevent easy translation of the results from one test to another.
This type of test is intended to help guide personalized treatment, but will doctors order it and payors reimburse it if it's not required for the safe and effective use of a drug?
One of the first projects between the firms will be to develop and commercialize a companion diagnostic for the MEK inhibitor binimetinib in NRAS-mutant melanoma.
The new study will evaluate how different assays measuring PD-L1 expression compare to one another, an issue raised in recently published research.
FDA has approved BMS' Opdivo with a test to guide treatment strategies, but according to the drug label testing isn't required to identify who should receive the drug.
The agency and sponsors detailed how the ovarian cancer drug Lynparza and BRACAnalysis CDx achieved simultaneous FDA review and approval last year.
Dako developed the PD-L1 CDx very specifically to fit Keytruda's mechanism and patients' outcomes to the drug.
In Science this week: genetic analysis of pollutant-tolerant fish, and more.
Researchers have found a rare carbapenem resistance gene on a US pig farm, NBC News reports.
New York officials are considering the use of a familial DNA search to get a lead on a suspect in the strangulation death of a runner.
NIH Director Francis Collins has selected a retired Army major general and cardiologist for the CEO spot at the agency's embattled Clinical Center.