Lab trade group sues FDA to halt regulation of tests developed at labs

A group representing clinical laboratories across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate tests developed at labs.

The lawsuit, filed in federal court in Texas by the American Association of Clinical Laboratories and PCR laboratory HealthTrackRx, alleges that the FDA lacks the authority to inspect tests developed at the lab. When did the FDA finalize its test regulation plan last month, several experts said it was only a matter of time before someone in the lab industry filed a lawsuit.

Lab-based tests have long been unregulated by the FDA because the agency deemed them low risk when it began regulating medical devices in 1976. However, since then, tests have become more numerous and complex, and a regulatory gray area has allowed unreliable tests to develop and harm patients. Infamous examples include Theranos blood tests as well misleading prenatal genetic testing from a number of companies.