|Scientific Subdivisions | The Journal of Molecular Diagnostics
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April 18, 2016: The May 2016 issue of The ChAMPion spans topics from Zika to the recent JMD publication on the results of AMP's microcosting project. Charles E. Hill, MD, PhD, updates membership on the development of Zika LDPs and the importance role community diagnostics will play as mosquito season arrives in the U.S.
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"Genomic Sequencing Procedures are changing the way clinicians are diagnosing and managing hereditary diseases and the delivery of oncology care," said Linda Sabatini, PhD, HCLD, First Author and Project Leader, Director of Molecular Diagnostics at NorthShore University HealthSystem. "We hope that laboratories will use these tools to assess their individual costs, to consider the value structure in their own patient populations, and to contribute their data to the ongoing dialogue regarding the impact of GSPs on improving patient care."
AMP is very concerned and disappointed to see the FDA taking enforcement action against the physicians at Texas Children's Hospital and Houston Methodist Hospital for their laboratory developed procedure (LDP) for Zika virus, which was designed to identify virus-specific RNA sequences in a large metropolitan area. Given the ongoing outbreak of the infection and risk of infection in the Houston area, these types of tests are critical for patient care and should be made available to these patients in need.View the News Release
Get a glimpse of AMP's recent work in education, innovation, and advocacy for molecular diagnostics.
Hot off the presses is the first edition of The ChAMPion Newsletter! The ChAMPion aims to better educate members on rapidly evolving public policy issues affecting molecular pathology. Check out the link to the first issue below, where you can read about recent AMP advocacy news including AMP's response to FDA's report on oversight of LDPs; Common Rule NPRM; Genetic Information Nondiscrimination Act (GINA); and two upcoming FDA workshops.
View The ChAMPion
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.
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.