Coalition for 21st Century Medicine Applauds FDA Decision to Wait to Publish Final LDT Guidance

Coalition of innovative diagnostic test manufacturers agrees that major implementation challenges with proposed regulatory policies should be resolved prior to implementation to avoid disruption of patient services

Washington, D.C. – On November 18, 2016, officials from the U.S. Food & Drug Administration (FDA) communicated informally with key stakeholders, including the Coalition for 21st Century Medicine, the decision to wait to publish Final LDT Guidance. While there was no formal statement issued by the agency, the Coalition applauds FDA’s public recognition of the importance of continuing to work with key stakeholder groups including the new Administration, Congress, and industry to align on any changes to the current regulatory landscape for laboratory developed tests (LDTs) before any changes are made and a regulatory “clock” toward implementation is triggered.

The Coalition continues to assert its position that a new regulatory framework for in vitro diagnostics, separate from the current medical device framework, is most appropriately established under a new diagnostics-specific statutory framework enacted by Congress if FDA is to establish appropriately balanced regulatory oversight of LDT diagnostic testing in coordination with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Further, the Coalition believes that any changes to the current balance of regulatory oversight must continue to support innovation and be “least burdensome” such that it enables companies and healthcare institutions to design, develop and offer new and important diagnostic tests to patients through a clear, reasonable, and predictable pathway.

The Coalition for 21st Century Medicine comprises some of the world’s most innovative diagnostic technology companies, clinical laboratories, venture capital companies, and patient groups and stands ready to provide input to FDA and Congress on any new regulatory proposals that might be considered in furtherance of a goal to promote innovation and avoid disruption to patient care while assuring that physicians and their patients receive accurate and high quality testing on which they can rely to make medical decisions.

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The Coalition for 21st Century Medicine represents more than two dozen of the world’s most renowned diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups. We’re working to ensure that high quality, innovative diagnostic tests – necessary to assure that timely and accurate information is available when diagnosis, prognosis, and therapy decisions need to be made – are available to patients and their physicians. To that end, we’re working with policymakers to maintain the balance between regulation and innovation and to ensure that regulatory policy promotes rapid access to new diagnostic information.