ADVOCACY
CLIA Modernization of LDPs
Enhances Transparency • Ensures Quality • Preserves Innovation
A working group of the Professional Relations Committee developed a proposal to modernize the CLIA regulations and maintain oversight of Laboratory Developed Testing Procedures (LDPs) under those regulations. AMP released the proposal on August 4, 2015. The working group is to be commended for wrestling with the issues and drafting a viable proposal that will provide reassurance that clinical validity is being assessed and information about LDPs is easily accessed by ordering physicians and the public, without elements that would curtail the ability of medical professionals to offer vital clinical services. The proposal consists of a tiered, risk-based structure that avoids duplication of activities within and between federal agencies.
Proposal Available Here: CLIA Modernization Proposal
View Proposal Presentation Slides: Proposal Presentation
Press on AMP's Proposal
Inside Health Policy - More Groups Back AMP's LDT Plan as Senate Staffers Urge Stakeholders to Press for Action
Genetic Engineering & Biotechnology News - Drawing Battle Lines over Lab Tests
Clinical Lab Products Magazine - Procedures, Not Tests
Diagnostic World News - Association for Molecular Pathology Puts Forth New Plan to Regulate Laboratory Developed Tests
Mendelspod - Still Unhappy with FDA's Plan to Regulate LDTs, Professional Lab Groups Go Direct to the Senate
GenomeWeb - Pathologists Take Alternative Lab Test Regulation Proposal to Senate
Inside Health Policy - Molecular Pathology Association Floats Risk-Based CLIA Modernization Plan
Oversight of LDPs Position Statments, Comments, and Reference Materials
Laboratory Testing and Patient Care - View Video
AMP's Principles for Oversight of LDPs
AMPs Comments to House E&C Committee on Regulation of In Vitro Clinical Tests Draft Legislation
AMP's written comments to FDA on LDPs
Signs from the 2014 Annual Meeting: Are you ready to be a "manufacturer"?
AMP Position Statement: Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests
FDA's website devoted to all information relevant to the draft framework: www.FDA.gov/LDTs
View all AMP Position Statements and Letters
For more information, please contact policy@amp.org.
