Wednesday, August 12, 2015

Association for Molecular Pathologists Releases Lab Regulation Plan

As released on its website, on August 4, 2015, the Association for Molecular Pathologists (AMP) met with Senate Finance Committee staff to discuss the AMP's framework for some upgraded controls or regulation of laboratory developed tests.  The project is titled, "Modernization of CLIA Regulations
for Laboratory Developed Testing Procedures (LDPs)."
More after the break.

The AMP is acting in response to two other plans that have been floated in Washington:

  • the FDA's draft framework for FDA regulation of many LDTs (released by the FDA in 8/2014 and the subject of Hill hearings and other workshops since then), and 
  • the Diagnostic Test Working Group legislative proposal, released in April 2015.  
    • (For more on the DTWG, here at Hyman Phelps and here and here at Genomeweb [subscription].)  
Prior to releasing its new plan, AMP recently commented publicly that the FDA plan and the DTWG plan could each "cripple clinical laboratories of all sizes"(here).

Get the AMP Documents:
The AMP's press release is here; the AMP's full LDT CLIA modernization plan, here (16 pages).

Coverage of the AMP proposal at Genomeweb, here.  Coverage in the subscription trade journal Gray Sheet, here.

What has AMP Proposed?
In brief, the AMP plan is an "enhanced CLIA" plan with three risk levels, although these are defined quite differently from the FDA's three risk levels.  The only high risk group would be MAAA tests, which would either be FDA approved or undergo a high risk pre market CLIA evaluation.  (This is consistent with CAP's position for a number of years that proprietary MAAA tests were the main occupant of an LDT high risk category.)   A low risk group is defined as LDT tests that are commonly accepted and have low risk of adverse events. In between, moderate risk tests would be reviewed in some detail for the first three labs offering them as an LDT, and after that would become on-the-record tests and the prior reviews would be the precedent for CLIA approval.  Updates would be easily handled unless they clinically and significantly altered the test or its risk classification.

For history buffs - Other formal proposals to enhance CLIA for molecular LDTs date back to a 2011 legislative approach (Sen. Burgess, Texas, H.R.3207, here).  There was also a proposal for a special new CLIA category for genetic tests in 2007/2008, but it died on the vine.

Nomenclature.  Whereas the FDA referred to tests like Oncotype DX in the decade carefully as "devices" - IVDMIA, in vitro devices of the multivariate index assay type - the AMA CPT chose to avoid this term and call them "multi analyte assays with algorithms (MAAA)."   Whereas the FDA has asserted that "lab developed tests" are "devices" the AMA CPT calls genomic tests "genomic sequencing procedures" and the AMP calls them "laboratory developed procedures" although the result of the procedure (as used by CLIA) is a "test."