Congressional Committee Members Publicly Release Discussion Bill on Lab Test Regulation

A plan for regulating laboratory-developed tests that a group of diagnostic manufacturers and labs had penned two years ago has resurfaced in the US House of Representatives with backing from a Republican and Democratic legislator. Representative Larry Bucshon (R-IN) and Diana DeGette (D-CO) publicly released the discussion draft of the so-called Diagnostic Accuracy and Innovation Act, which is fashioned closely after a framework developed by the so-called Diagnostic Test Working Group in 2015. "Our discussion draft builds upon previous efforts to establish a modern framework for the regulation of diagnostic tests, which will benefit patients and advance precision medicine," Bucshon and DeGette, both on the House Energy & Commerce Committee, said in a joint statement. "This updated approach is an effort to improve public health, foster more innovation, and strike the right regulatory balance. We hope to continue a bipartisan dialogue in the 115th Congress that includes input from patient groups, clinical laboratories, manufacturers, and other stakeholders." This proposal was offered by the DTWG as an alternative to the FDA's controversial draft guidance for regulating LDTs, and found its way into a House E&C draft bill. The committee has been working with stakeholders on the draft for some time.

INDUSTRY NEWS TAGS: Molecular Diagnostics

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