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 ...

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, ...

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 ...

How Our Lab Is Helping Develop An Alzheimer's Test That Can Be Done At Home. Imagine diagnosing one of the most challenging ...

The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...