|Scientific Subdivisions | The Journal of Molecular Diagnostics
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The AMP paper, published in JMD, provides residency programs with specific recommendations from subject matter experts on 10 major molecular pathology topics: basic molecular pathology goals and laboratory management; basic concepts in molecular biology and genetics; technology; inherited disorders; oncology; infectious diseases; pharmacogenetics; histocompatibility and identity; genomics, and information management.
Get a glimpse of AMP's recent work in education, innovation, and advocacy for molecular diagnostics.
AMP has responded to FDA's recently released report titled "The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies" with a detailed analysis of the laboratory developed procedures (LDPs) mentioned in the FDA report. After a careful and thorough examination of the LDPs mentioned in FDA's report, AMP concluded that FDA oversight would likely prevent few of the potential patient harms postulated by the Agency. Rather the Centers for Medicare & Medicare Services (CMS), which has statutory authority through the CLIA program, would have been more successful than FDA at addressing these potential problems.
AMP is pleased to endorse the CPIC sponsored draft manuscript Term Standardization for Clinical Pharmacogenetic Test Results: Alleles and Phenotypes. CPIC has assembled an international workgroup, utilized a Delphi process to develop their recommendations, and sought feedback from a number of professional organizations. We are confident that our members' expertise as molecular pathologists can contribute valuable insight and foundations upon which this and other CPIC projects may benefit.
AMP urged the House Energy and Commerce Committee to use AMP's CLIA modernization proposal as the basis for legislation where the goal is to preserve innovative patient care by building upon the current CMS-based system for oversight of laboratory developed procedures.
The session included presentations from various leaders in the field, all of whom are very knowledgeable regarding reimbursement for molecular diagnostic tests. "Defining and addressing the issues that prevent important clinical lab testing from being available to our patients will continue to be a major advocacy focus for AMP in 2016," said Samuel K. Caughron, MD, 2016 AMP Economic Affairs Committee Chair.
The session at the AMP 2015 Annual Meeting provided an update on the latest developments in Washington, DC. "What concerns me most about the direction that FDA is going with regulation of LDPs is that it will add to the significant economic burden that laboratories now face and slow their ability to develop new tests to respond to pressing public healthcare needs," said Congressman Burgess.