Association for Molecular Pathology


June 2011, Volume 17, Number 2


Professional Relations Committee Report

Elaine Lyon, PhD

By Elaine Lyon, PhD
Chair, Professional Relations Committee

The Professional Relations Committee (PRC) continues its course in responding to the FDA. Two FDA draft guidances were released this winter. The PRC with the help of our Industry Interest Group responded to Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile. We also responded to the guidance Establishing the Performance Characteristics of Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus. We are now preparing a response to the draft guidance regarding IVDs labeled as RUOs and IUOs.

The members of the PRC are anticipating the FDA’s draft guidance for laboratory developed tests (LDT). Dr. Alberto Gutierrez (the director of the Office of In Vitro Diagnostic Device Evaluation and Safety) spoke at the ACLA annual meeting and explained that, since LDT regulation will have a wide impact, the review process has been slow. He commented that elements of the framework would apply to all LDTs and would include beginning with high-risk tests, registration and listing (coordinated with the NIH Genetic Test Registry), classification panels, modification of current review where appropriate and piloted third party reviews and inspections. Three groups of LDTs that may be exempt are rare diseases, biothreats or emerging infectious diseases and some “traditional” LDTS that are well established, well validated and low risk.

We had a “Hill Day” on March 23rd, with Mary Williams and Jennifer Leib and I meeting with six Congressional offices. The discussions with staff from Senators Orrin Hatch (R-Utah) and Tom Harkin (D-IA) centered on oversight of laboratory developed tests. We shared AMP’s main concerns with FDA oversight as being:

  1. Defining risk
  2. Labeling our services as “device manufacturers” rather than “health care professionals”
  3. Having oversight from two regulatory bodies, CLIA and FDA.

Discussions with staff from Senator Al Franken (D-MN), Senator Richard Blumenthal (D-CT), Senator Mike Lee (R-UT), and Senator Amy Klubuchar (D-MN) focused on DNA patents. Staff members from different offices have varied knowledge about DNA patents in general and AMP’s case in particular. We informed them of the oral arguments before the court of appeals for the Federal Circuit hearing on April 4.

The PRC thanks the AMP members that have shown interest in the junior member position on our committee. We received a number of excellent applications which we are reviewing. We are hoping to have a decision within the next month for this position.