The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests. The FDA approves and clears many types of lab tests ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

Because of its high accuracy, laboratory-based polymerase chain reaction (PCR) testing is the gold standard for infectious disease diagnostics. However, PCR technology requires highly trained staff ...

Lateral flow assays have been a popular point-of-care testing platform for decades. Researchers are now turning these simple tests into complex biomedical assays which can be used in the home, ...