FDA announces closer scrutiny of lab-developed tests, companion diagnostics

In an effort to validate the accuracy, consistency and reliability of diagnostic testing, the FDA has announced its intent to issue a final guidance document on the development, review and approval of companion diagnostics. The agency has also alerted Congress that it will publish a risk-based oversight framework for laboratory-developed tests, according to an agency press release.

“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA commissioner Margaret A. Hamburg, MD, said in the release. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

According to the press release, the objective of the final guidance, which considers public comment on the 2011 draft guidance, is to promote early collaboration for companion diagnostics, resulting in quicker access to treatments for patients with life-threatening diseases.

In its notice to Congress on laboratory-developed tests, the FDA cited concerns about lack of post-market safety monitoring and wrote that tests that may not have undergone a clinical review or analytical testing may be used by physicians who do not know the device is not cleared or approved by the FDA.

The regulatory framework is risk-based and will categorize risk according to class, with class I designated for devices and tests which present the lowest risk and class III for those which pose the greatest risk. The FDA wrote that it “intends to … exercise enforcement discretion” for low-risk devices, but will require registration and listing, as well as adverse event reporting standards. High-risk tests will be required to undergo premarket review and other quality control measures.

“With today’s notification of the agency’s intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “The agency’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.”

While the FDA did not announce a date for the issuance of the final guidance, they are required to notify Congress at least 60 days before issuing a draft or final guidance document.