Pathologists, academic medical centers, industry, laboratories, and patient groups urge Congress to enact fit-for-purpose regulatory framework for diagnostic tests.
WASHINGTON – The Coalition for Effective Diagnostics has called on House and Senate leaders to enact a comprehensive diagnostic testing reform package to tailor the US Food and Drug Administration (FDA) regulatory oversight of laboratory-developed tests (LDTs). The new coalition that includes the College of American Pathologists (CAP), academic medical centers, diagnostic manufacturers, laboratories, and patient groups is seeking to build consensus legislation to establish a fit-for-purpose regulatory paradigm for diagnostic tests that preserves innovation and ensures continued access to accurate and reliable tests.
In a letter sent to House and Senate leaders on November 12, the coalition said Congress has an opportunity to pass legislation with regulatory approval pathways designed to match the unique characteristics and risk profiles of diagnostic tests. In April, the FDA released a final regulation to end its longstanding enforcement discretion policy for LDTs and would instead proceed with using regulatory authorities governing medical devices for its LDT oversight framework.
“Efforts to comply with the phased approach set forth in the final rule are already underway,” the groups said. “Congress must act now to ensure regulatory certainty and avoid disruption to patient access to life saving and life preserving diagnostics. The Coalition stands ready to work with you toward this goal.”
Read the full letter to Congress. The coalition consists of the CAP, Mayo Clinic, Roche, Thermo Fisher, Alexion, and Friends of Cancer Research.
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About the College of American Pathologists (CAP)
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.