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Alternative Proposals for Lab Test Regulation

Are There Opportunities for Consensus?
A GenomeWeb Report February 2016

Amid multiple proposals on LDT regulation, are there opportunities for consensus?
By Turna Ray

The lab industry entered 2016 in a staring contest with the US Food and Drug Administration that began two years ago when the agency released its draft guidance on regulating laboratory-developed tests (LDTs).

During the course of 2015, pathologists and lab industry players fought the agency’s bid to regulate LDTs on several fronts. The American Clinical Laboratory Association (ACLA) hired lawyers to build a legal argument against FDA’s authority to regulate the tests and there was a congressional hearing in November to discuss the matter.

Underscoring the discord in the lab community on this topic is the fact that several groups issued alternative regulatory proposals during 2015. Three influential organizations — the Diagnostic Test Working Group, the Association for Molecular Pathology, and the College of American Pathologists — have taken regulatory proposals to Congress, while other stakeholders are working with the FDA and legislators on finding a solution to the LDT oversight issue.

CAP, which issued a regulatory plan in October, wants to improve regulation for the majority of LDTs through the Clinical Laboratory Improvement Amendments, the framework administered by the Centers for Medicare & Medicaid Services under which LDTs have been regulated since 1992. However, the organization wants FDA oversight for high-risk tests, including tests that “produce a result that is not independently verifiable.” Under AMP’s approach, released in August, all lab-developed testing procedures (LDPs) — a term the group maintains more accurately describes the role of labs than LDTs — would be overseen under CLIA. However, AMP proposes that if a laboratory offering so-called multi-analyte algorithm-based assays (MAAAs), which are tests using proprietary algorithms, does not want to reveal those procedures to third-party reviewers, then it can submit the LDP for review by the FDA…

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