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Industry Urges Congress to ‘Modernize’ Clinical Diagnostics Regulations

Posted 11 May 2018 | By Ana Mulero 

Industry Urges Congress to ‘Modernize’ Clinical Diagnostics Regulations

From healthcare companies and patient advocacy groups to laboratories and diagnostic manufacturers, upwards of 80 organizations called on Congress to prioritize legislative reform of clinical laboratory diagnostics in 2018.

In a first-of-its-kind 9 May letter to congressional leaders, the organizations argued prompt modernization of statutory oversight is needed to ensure continued “robust access to innovative and high quality clinical laboratory diagnostics,” including laboratory developed tests (LDTs) and in vitro diagnostics (IVDs), to "unleash diagnostic innovation and improve the quality of care available to patients."

The organizations’ collective push for legislative reform coincides with the US Food and Drug Administration’s (FDA) recent guidance on IVDs and next-generation sequencing technology, via newly finalized or drafted guidance documents, providing recommendations aimed at streamlining developers’ market entry.

Further, the organizations also argued that diagnostics reform has already received bipartisan support. This makes it “a suitable issue to be completed in 2018,” they wrote.
 
In March 2017, Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) released a 215-page discussion draft—the Diagnostic Accuracy and Innovation Act (DAIA)—offering a regulatory shift at FDA, such as with the establishment of a new classification system for in vitro clinical tests (IVCTs) and a new user fee program.
 
Industry associations AdvaMedDx and the Biotechnology Innovation Organization, the American Clinical Laboratory Association, and device companies Abbott, BD, Cardinal Health, Foundation Medicine, J&J and Roche Diagnostics, are among the undersigned organizations. They intend to “continue the work necessary to finalize a consensus diagnostics reform package this year.”

Categories: Regulatory News

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