WASHINGTON, DC - The Subcommittee on Health, chaired by Rep. Joseph Pitts (R-PA), today held a hearing titled, “Examining the Regulation of Diagnostic Tests and Laboratory Operations." The hearing builds upon previous discussions as part of the 21st Century Cures process, especially the feedback received in response to the committee’s white paper on A Modernized Framework for Innovative Diagnostic Tests, and the discussion draft working toward a legislative solution. Testifying before the subcommittee were officials from the FDA and CMS about each agency’s respective responsibilities and areas of expertise in the regulation of diagnostic tests, as well as what they envision their respective agencies roles to be moving forward.
“Throughout the 21st Century Cures initiative, ‘biomarkers,’ ‘precision medicine,’ and ‘targeted therapies’ were a few of the most consistently uttered terms and concepts," said Chairman Pitts. “In order to advance each of them, we must establish a regulatory environment that fosters the development of and access to innovative, accurate and reliable diagnostic testing. Today’s discussion puts us on that path."
Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, echoed that overarching goal. Shuren testified, “FDA is committed to developing a final policy for oversight of LDTs that encourages innovation, improves patient outcomes, and strengthens patient confidence in the reliability of these products."
“As I said at our first forum on this topic in July 2014, these increasingly important and complex tests are providing researchers and clinicians with valuable tools to match the right patients with the right treatments," stated full committee Chairman Fred Upton (R-MI). “We must ensure that our laws and regulations keep pace so that innovation in this space continues and patients benefit from accurate and reliable tests."
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