Professional Relations Committee Report
By Elaine Lyon, PhD
We welcome a new Professional Relations Committee (PRC) Chair-elect, Roger Klein, and our returning Committee members, Jean Amos Wilson, Stephen P. Day, Rajyasree Emmadi, Daniel Farkas, Andrea Ferreira-Gonzalez, Roberta Madej, Shelby Melton, Jan Nowak, Vicky Pratt, and Daniel Sabbath. We also welcome Iris Schrijver, as AMP’s President-elect. We thank Timothy O’Leary for his help this past year and will keep him informed in his new position as AMP President.
Last Fall, a coalition of nine professional organizations (including AMP) requested to meet with the FDA to discuss regulation of Laboratory Developed Tests (LDTs). The meeting, held November 22nd, discussed the following topics: What constitutes an LDT? How can unique advantages of an LDT continue within FDA regulation?; Registration and Listing - Forum to discuss various alternatives to registering clinical laboratories as a medical device manufacturer and listing LDTs; and FDA Regulation of LDTs in a CLIA Framework - Forum to discuss the overlaps, gaps and possible efficiencies. PRC members Vicky Pratt, Andrea Ferreira-Gonzalez, Mary Williams and I participated in panel discussions. The FDA was not able to provide many specifics, although they emphasized a risk-based approach. We are waiting for their draft guidance document.
In January, we provided comments to the Agency for Healthcare Research and Quality on the draft Technology Assessment (TA), Update on Horizon Scans of Genetic Tests Currently Available for Clinical Use in Cancers. In summary, we commented on their broad use of the term “genetic”, requested authors to consult with subject matter experts prior to finalizing the report, requested that tests be described based on their molecular entities rather than using brand names, and requested that the TA be modified to distinguish between test manufacturers and clinical laboratories developing LDTs.
We are preparing responses to two FDA draft guidances: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile and 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 appreciate the comments and help from our Industry Interest Group, as well as, the PRC in preparing these responses.
Thanks to all on the Committee for lively discussions and productive comments!