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Diagnostic Industry Stakeholders Send Letter to Congress in Support of DAIA

NEW YORK (360Dx) – A group of diagnostic manufacturers, laboratories and advocacy groups sent a letter to Congress yesterday urging lawmakers to act this year to enact legislation for modernizing oversight of clinical laboratory diagnostics, including laboratory-developed tests and in vitro diagnostics.

The letter, signed by the American Clinical Laboratory Association, the diagnostic manufacturer's advocacy group AdvaMedDx, and the American Cancer Society Cancer Action Network, as well as 78 other manufacturers, laboratories, and advocacy organizations, noted that a discussion draft of the Diagnostic Accuracy and Innovation Act was released last year and is currently being reviewed by the US Food and Drug Administration. Progress on the discussion draft puts its passage "within reach," the group said.

"As stakeholders we stand ready to continue the work necessary to finalize a consensus diagnostic reform package this year," the letter stated.

The letter was addressed to Senator Lamar Alexander (R-TN), Chair of the Senate Committee on Health, Education, Labor and Pensions, and Senator Patty Murray (D-WA), ranking member of that committee, as well as Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO), who jointly released the DAIA discussion draft. Buschon and DeGette are respectively chairman and ranking member of the House Committee on Energy and Commerce.

DAIA, released for stakeholder input in March 2017, was fashioned after a framework developed by the Diagnostic Test Working Group in 2015, and lays out a plan to create a new in vitro clinical test (IVCT) category, which would comprise both test kits and LDTs.

The FDA has suggested a precertification program as part of its technical assistance to DAIA, according to a technical assistance document obtained by GenomeWeb.

"Many of the concepts that DAIA proposes are important to include in any legislative framework, including, for example, a streamlined path to market," the FDA technical assistance document said. "FDA also recommends further streamlining by including a precertification for many tests."