The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the ...

DTC Genetic Health Risk Tests Exempted from FDA 510 (k) Requirements Manufacturers of direct-to-consumer (DTC) genetic health risk (GHR) assessment systems were directed to withdraw pending 510 (k) ...

Forbes contributors publish independent expert analyses and insights. Margaux Lushing is an LA-based reporter covering wellness. As interest in at-home testing accelerates, digital health companies ...