Unlike the failed Theranos company that ended up being a scam, BetterWay does not test the blood in shoebox-size equipment.

A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

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, ...

The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, ...

Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, ...

The State Public Health Laboratory, one of the apex referral laboratories in the State, has developed its own molecular diagnostic test kits to identify five common species of free living amoeba ...

The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...

Researchers developed a wearable pad that detects inflammation and cancer biomarkers in menstrual blood using smartphone ...

Bio-Techne faces significant macro and policy headwinds, including reduced academic research funding, China risks, and U.S.

An interdisciplinary research team from the Allergology and Veterinary Medicine Divisions at the Paul-Ehrlich-Institut (PEI) has developed a novel laboratory test that enables the determination of ...