The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...

Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TacroType (TM) Pharmacogenetic Test, a new laboratory developed test designed to help inform clinicians ...

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...

The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...

NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.

The FDA has approved a novel diagnostic for prostate cancer that looks to improve upon the common screener for prostate-specific antigen, known as a PSA test. The IsoPSA blood test, developed by ...