The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
Key approvals announced in June represented important steps forward for the lab testing industry.
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
Congress brings back controversial Trump plan scrapped by the Biden administration.