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

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...