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, ...

One of the main threads running through our most-read stories of 2025—as much as ever in the medtech industry writ large—is ...

The US Food and Drug Administration (FDA) has granted approval for Thermo Fisher Scientific's Oncomine Dx Target Test as a treatment for non-small cell lung cancer (NSCLC). The test serves as a ...

BUFFALO, N.Y. – The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the University at Buffalo School of Nursing’s wet ...

Swiss-based Roche announced this month that it has received U.S. regulatory clearance for a less-complex vitamin D test in the United States, which the company said opens the door to more efficient ...

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved additional ...

The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the School of Nursing’s wet lab. The lab, led by nursing researcher ...