FDA unveils first-ever plans to regulate genetic diagnostic testing
- The FDA has announced that it will take steps to ensure that companion diagnostic tests and laboratory developed tests (LDTs) are safe and produce reliable, accurate results.
- For the first time, the FDA plans to put forth a risk-based regulatory oversight framework for monitoring LDTs.
- LDT use in genetic testing has grown steadily in recent years. More than 11,000 such tests could be affected by the FDA's planned regulatory regime.
Watchdog organizations such as the Government Accountability Office (GAO) have long been calling on the FDA to more heavily scrutinize diagnostic tests, and particularly LDTs, before they go to market. These agencies have argued that many of these tests are useless to patients and have little in the way of clinical studies to back up their efficacy -- a concern echoed by the FDA in its announcement.
According to an FDA press release, the planned regulatory framework will include pre-market review for higher-risk LDTs. These include tests that that have the same intended use as other diagnostic products on the market that have already gone through more stringent FDA review processes.
"The [FDA's] oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, of the upcoming regulatory framework.