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

A revolutionary STI test developed by UK-based Linear Diagnostics is on track to dramatically reduce the time it takes to ...

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, ...

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

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

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

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 ...

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

A team led by Rutgers University-New Brunswick engineers has developed a portable device capable of detecting rare genetic ...