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Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform

Diagnostic firms formed the Coalition for CLIA Waiver Reform last month with the goal of enlisting patients, labs and physicians in the fight to turn back what they say are unreasonable FDA standards for a test to gain access to the broader market of “waived” labs.

Diagnostic firms say FDA made a crucial error in judgment in a 2008 guidance that has blocked the way for more point-of-care testing; now they hope to rally labs, physician groups and patient organizations into a coalition to convince the agency to change course.

The guidance in question addressed standards for achieving a waiver for a test under the Clinical Laboratory Improvement Amendments, which allows the assay to be used by more rudimentary laboratories,...

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