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 (Read more...)

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