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

  • July 31, 2014

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.”

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