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.
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.
An opinion piece in the New York Times urges lawmakers to keep genetic protections in place.
Research funding in Canada is to remain mostly the same, ScienceInsider reports.
In Science this week: random DNA replication errors play role in cancer, and more.
The Bill and Melinda Gates Foundation embarks on an open-access publishing path.