The FDA clearances address laboratory challenges including staff shortages, limited space, and rising test volumes, the firm said.

PCR is a mainstay in diagnostics, but whether a sample is collected at a clinic or at home, such tests require sending a sample to a lab and then waiting for results. A new FDA authorized ...

Blood tests are one of the most widely used and helpful tools in modern medicine. Whether ordered in a clinic or done through an at-home kit, they work by analyzing samples of your blood to uncover ...