The Association for Molecular Pathology Appreciates Opportunity to Discuss with Congressional Leaders How Laboratory Developed Procedures Benefit Patient Care
Bethesda, MD, September 22, 2016:
The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostics professionals, recently participated in two events designed to help educate lawmakers and congressional staff about laboratory developed procedures (LDPs) and the vital role they play in precision medicine and patient care. Both the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) Hearing and the Co-hosted Congressional Briefing provided bipartisan forums for AMP leaders to discuss how LDPs are currently designed, validated, regulated, and used in a variety of clinical settings.
“On behalf of AMP’s more than 2,300 dedicated molecular laboratory professional members, I would like to thank Chairman Lamar Alexander and the Senate HELP Committee for convening the hearing on LDP regulation,” said Charles E. Hill, MD, PhD, AMP President. “We have reached a critical point in the era of precision medicine and it is imperative that our lawmakers understand all of the potential harms and benefits of additional LDP regulation before embarking on a massive new program that could be enormously disruptive to health care and likely have profound adverse consequences for patients across the country.”
AMP has long maintained that the involvement of appropriately trained and qualified laboratory professionals is critical to the development of accurate and reliable LDPs, as well as for correct utilization, precise interpretation, and appropriate application of molecular test results. In October 2015, AMP submitted a detailed proposal to the Senate HELP Committee that modernizes the current CLIA regulation program, expands its current network of third-party medical experts, and utilizes scientific expertise from FDA and CDC. The AMP proposal provides assurance of quality, analytical validity, and clinical validity without jeopardizing innovation or patient access to necessary care, and does so in a tiered, risk‐based structure that avoids duplication of activities within and between federal agencies.
“AMP members share a common goal of putting the patient first and preserving broad access to essential medical care,” said Karen L. Kaul, MD, PhD, Chair, Department of Pathology and Laboratory Medicine and Duckworth Family Chair at NorthShore University HealthSystem, Former AMP President, Former Editor-in-Chief of The Journal of Molecular Diagnostics, Witness at Senate HELP Hearing, and Moderator of the Congressional Briefing. “We are committed to working with congressional leaders on both sides of the aisle and other key stakeholders to build on the success of the thousands of LDPs offered today and develop a streamlined regulatory approach that ensures high-quality patient care, enhances transparency, and preserves innovation.”
For more information on AMP’s past position statements and letters on LDPs, please visit:
• AMP Responds to FDA Report on Oversight of Laboratory Developed Testing Procedures
• AMP Submits Written Testimony for Hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations”
• Congressman Michael Burgess, MD, Speaks at Session on CLIA Modernization of Laboratory Developed Procedures at AMP Annual Meeting
• AMP Meets with Senate HELP Committee and Presents a CLIA Modernization Proposal
• AMP Submits Written Comments to FDA on Proposed Regulation of Laboratory Developed Tests
The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's 2,300+ members practice in the various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions, and oncology. They include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit www.amp.org.