This up-front work, generally defined as design inputs and risk management, helps to inform what the test needs to do and guides subsequent performance studies to demonstrate that the test works ...

In the 1970s and ’80s, most lab-based tests were “lower risk, small volume” products used mostly for local patients, according to the FDA.

Last fall, the Food and Drug Administration (FDA) finally took steps toward an action that it had been publicly considering for over four years: the regulation of laboratory-developed tests (LDTs).

Laboratory is testing new virtual reality (VR) headset technology that could change how lab staff are trained and evaluated.

The Food and Drug Administration says it plans to begin regulating laboratory-based medical tests. It's a multibillion-dollar industry that regulators say poses a growing risk to patients.