Tag: lab industry

Proposed Bill in Congress Would Regulate LDTs

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for

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ARUP Laboratories Earns CAP’s ISO 15189 Accreditation

CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitment but now have definitive proof, ARUP said. Also, lab administrators believed that gaining accreditation

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