The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostics professionals, today announced the recipients of the Jeffrey A. Kant Leadership Award and the AMP Meritorious Service Award. Together with the AMP Award for Excellence in Molecular Diagnostics, these awards will be presented at the AMP 2016 Annual Meeting.
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.
The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostic professionals, today announced two upcoming events designed to help engage key stakeholders and educate lawmakers about the vital role laboratory developed procedures (LDPs) play in patient care.
Complimentary media registration packages are available for AMP's upcoming 2016 Annual Meeting in Charlotte, North Carolina.
Eric Lander, PhD, President and Founding Director of the Broad Institute of MIT and Harvard, and Professor of Biology at MIT and Professor of Systems Biology at Harvard Medical School, has earned this year's Award for Excellence in Molecular Diagnostics for his countless contributions to the field. The award will be presented at the AMP 2016 Annual Meeting on November 10, 2016 in Charlotte, N.C. Following the award presentation, Dr. Lander will deliver a special lecture on his 35-year journey uncovering insights to benefit human health.
AMP has established new standards for defining and assessing the clinical utility of molecular diagnostic testing procedures for inherited diseases and cancer. In a new report published in The Journal of Molecular Diagnostics, AMP recommends a fundamental shift to achieve the proactive, patient-centered approach necessary for modern healthcare. This report is available online free of charge to both members and non-members.
The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostic professionals, today announced that it looks forward to working with the U.S. Food and Drug Administration (FDA) to determine the best adaptive approach to regulating Next-Generation Sequencing (NGS) tests. AMP plans on submitting formal comments to the two new draft guidance documents, "Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases" and "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics, which were issued on July 6, 2016 as part of President Obama’s Precision Medicine Initiative.
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced today the open comment period for the revised evidence-based guideline, “Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors.”
In 2014, AMP, with the help of Boston Healthcare Associates, gathered more than a dozen protocols to analyze cost information about laboratory validation, pre-analytics, sequencing, bioinformatics, and interpretation. A major objective of the project was to provide laboratories with tools to accurately estimate the cost of performing GSP services. The CPT codes for these GSPs went into effect on January 1, 2015. To help establish favorable reimbursement for these GSP services, the release of these tools deliberately coincided with the Centers for Medicare and Medicaid Services’ (CMS) gapfill timeline. Laboratories can use them to effectively communicate the cost and value of various GSP services to their Medicare Administrative Contractors (MACs).
The Association for Molecular Pathology (AMP), the premier global, professional society serving molecular diagnostics professionals, 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 detecting Zika virus.
The paper 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.
AMP submitted written testimony to the House Energy and Commerce Subcommittee on Health for their hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” AMP urged the Committee to use AMP’s proposal to modernize the Clinical Laboratory Improvement Amendments (CLIA) at the Centers for Medicare & Medicaid Services (CMS) as the basis for legislation that would preserve innovative patient care by building upon the current CMS-based system for oversight of laboratory developed procedures (LDPs).
The session included presentations from various leaders in the field, all of whom are very knowledgeable regarding reimbursement for molecular diagnostic tests. Rina Wolf, MHA, XIFIN, Inc., gave a “real world” view of current factors influencing payment for molecular diagnostics, including the recently released Protecting Access to Medicare Act (PAMA) proposed rule and its scheduled implementation. John Pfeifer, MD, PhD, provided an overview of the process his laboratory used to achieve sustainable reimbursement for next generation sequencing (NGS) tests and Erick Lin, MD, PhD, Ambry Genetics, provided advice on successfully working with payers.
The AMP 2015session, Modernization of CLIA Regulations for Laboratory Developed Testing Procedures, an Update from Washington, featured keynote speaker Congressman Michael Burgess, MD (R-TX), a member of the House Energy & Commerce Committee, who introduced legislation in 2011 to update the current CLIA regulations and is a long-time supporter of modernizing and strengthening the existing CLIA program.
The Association for Molecular Pathology announced today its 2015 award winners for the Award for Excellence in Molecular Diagnostics, the Jeffrey A. Kant Leadership Award, and the AMP Meritorious Service Award. All three awards will be presented during the AMP 2015 Annual Meeting, November 5-7 in Austin, Texas, with a special lecture by the Award for Excellence recipient on the morning of November 5.
Clinical use of next generation sequencing (NGS) was implemented early in cancers and inherited diseases; now, its technology and applications are being applied to infectious diseases.
AMP’s Proposal for Modernization of CLIA Regulations for Laboratory Developed Testing Procedures provides assurance of quality, analytical validity, and clinical validity without jeopardizing innovation or patient access to necessary care in a tiered, risk-based structure that avoids duplication of activities within and between federal agencies.
The article describes the current and future roles of the laboratory professional as genomic sequencing analysis becomes an ever more increasingly important tool in diagnostic medicine.
The work of the IAC began in 2010 with the formation of the International Affairs Working Group. Since that time, the group has successfully collaborated to form four AMP International Affiliate Organizations, support more than a dozen conferences outside the U.S. with AMP speakers, and further expand AMP’s educational initiatives to Europe, Asia, and other continents beyond North America.
In general, the article supports the notion that this type of diagnostic testing in and of itself allows for earlier diagnosis, faster and more targeted treatment, reduced costs, and increased quality of life and even increased lifespan for the patient.
The American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) today released a draft of a clinical practice guideline on the use of molecular marker testing for patients with primary or metastatic colorectal carcinoma. This evidence-based guideline will help establish standard molecular marker testing, guide targeted therapies, and advance personalized care for these patients.
AMP urged FDA to focus its attention on helping to ensure the performance characteristics of next generation sequencing (NGS) instruments, reagents, and related software. AMP further recommended that FDA partner with private sector organizations and experts to set standards for FDA-cleared or approved instruments, test kits, and software.
AMP releases cost analysis results and health economic evaluation models for several genomic sequencing procedure codes.
AMP presented at the U.S. Food and Drug Administration public workshop, “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests,” outlining specific ways that FDA could best facilitate innovation of precision medicine. The purpose of the workshop is to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using NGS technology.
By eliminating the barriers outlined in “The Perfect Storm” paper, genome-based research will continue to play a critical role in the development of more powerful tools to treat complex diseases such as cancer, diabetes, and cardiovascular disease.
The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular testing professionals, will speak at the U.S. Food and Drug Administration’s (FDA) Public Workshop, Framework for Regulatory Oversight of LDTs.
AMP announced its 2014 award winners. Recipients of the Award for Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership Award, and AMP Meritorious Service Award were presented at the AMP Annual Meeting this past week in National Harbor, Maryland.
The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular testing professionals around the world announced the creation of an Informatics Subdivision to address the important role of this scientific discipline in molecular pathology.
AMP's late-breaking session, titled, “Framework for Oversight of LDTs: A Conversation with FDA” is scheduled for Thursday, November 13, 2014 at 1:00pm EST. Immediately following, AMP will host a press conference, convening a panel of molecular pathology clinical professionals, from a variety of clinical laboratory settings, to appropriately frame the discussion regarding clinical care and appropriate regulation.
AMP today reaffirmed its position that the vast majority of laboratory developed procedures should continue operating under the regulation of the CLIA program at the CMS and not be subject to pre-market review by the FDA, as suggested in the draft guidance notification issued to Congress on July 31, 2014.
The Association for Molecular Pathology (AMP) announced today that Francis S. Collins, MD, PhD, Director of the National Institutes of Health (NIH), will give a special address at the AMP 2014 Annual Meeting and 20th Anniversary Celebration. The meeting will be held November 12-15, 2014 at the Gaylord National Resort and Convention Center in National Harbor, MD (just outside of Washington, DC). The theme of the event is “Realizing the Dream of Precision Medicine.”
The Association for Molecular Pathology (AMP) joins the American Society for Clinical Pathology (ASCP) to celebrate the vital role laboratory professionals and pathologists play in health care.
The Association for Molecular Pathology (AMP) released a report today in The Journal of Molecular Diagnostics on recommendations for a molecular diagnostics curriculum at both the baccalaureate and master’s levels of education.
: The Association for Molecular Pathology (AMP) released a special article in the January 2014 issue of The Journal of Molecular Diagnostics titled “Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests“ (LDTs).
. The event, to be held November 14-16 at the Phoenix Convention Center in Phoenix, AZ will highlight an array of topics focusing on genomics, proteomics, informatics, reimbursement, and optimization of patient care.
The Association for Molecular Pathology (AMP) proudly announces its slate of award winners for 2013. Each recipient was carefully vetted and selected by a distinguished group of AMP leadership.
The Association for Molecular Pathology (AMP) submitted comments to the Centers for Medicare and Medicaid Services (CMS) expressing serious concerns about the gap fill process.
The Association for Molecular Pathology (AMP) is proud to announce its newly elected leaders for 2014.
Jan A. Nowak, PhD, MD, has been awarded the Association for Molecular Pathology 2013 Leadership Award. This is the highest honor that AMP gives exclusively to one of its members - one who has demonstrated exceptional leadership in the accomplishment of the mission and vision of AMP.
The Association for Molecular Pathology is proud to announce it will join the Federation of American Societies for Experimental Biology (FASEB) on July 1, 2013. The FASEB Board approved AMP’s application for membership on June 3, 2013.
AMP applauds the U.S. Supreme Court on their ground breaking, unanimous decision.
Today a coalition representing over 120,000 medical and laboratory professionals and institutions that perform the vast majority of clinical molecular pathology testing in the United States released a joint statement regarding new Medicare prices for those tests.
Leading health care organizations issue guideline recommendations for molecular testing and targeted therapies.
The proposal of the Association for Molecular Pathology Economic Affairs Committee details two schemes for coding genomic sequencing assays. Submitted in March to the AMA's CPT Editorial Panel.
The timely report provides a detailed and compelling overview of the landscape of next generation sequencing (NGS) technology and its clinical relevance and impact on improving patient care.
AMP v USPTO case challenges patents as dangerous roadblock to patient care, medical Innovation.
The Association for Molecular Pathology (AMP) announced a record-breaking number of abstract submissions for the AMP 2012 Annual Meeting on Genomic Medicine, marking a 40% increase over last year. The Meeting will be held October 25-27, 2012 in Long Beach, CA. An increase in the number of meeting attendees and exhibitors is anticipated as well.
The Association for Molecular Pathology (AMP) today announced that it is close to finalizing a framework proposal for CPT coding of Next Generation Sequencing (NGS) assays.
The Association for Molecular Pathology (AMP) today announced that it has formed a working group that will focus on the oversight of laboratory-developed tests (LDTs). In 2009, the U.S. Food and Drug Administration (FDA) announced an intention to abandon its regulatory policy of enforcement discretion toward some laboratory developed tests.
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