It’s a multi-billion-dollar industry that the agency says poses a growing risk to patients because of potentially inaccurate results. the proposed rule would formally bring thousands of tests performed in large laboratories under FDA oversight.
On Tuesday, the Food and Drug Administration revealed that the test had received emergency approval. The new kit, produced by North Carolina-based LabCorp, allows people to collect their own sample from home and send it to be tested. (Las Vegas Review-Journal)