SALT LAKE CITY — Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don't exist or ...

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, ...

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, ...

Kadakia is a medical student at Harvard Medical School. Ross and Ramachandran are physicians and professors at the Yale School of Medicine. They submitted an amicus brief in support of the FDA in ACLA ...

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

Easier than a blood test, saliva tests have the potential to detect cavities, infections and even cancer. But a lack of ...

Cleveland Diagnostics, a biotechnology company co-founded by Cleveland Clinic in 2013, announced it has secured FDA clearance for its first cancer-detection kit. The company’s product, called IsoPSA, ...