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AMP Appreciates Opportunity to Discuss with Congressional Leaders How Laboratory Developed Procedures Benefit Patient Care

AMP 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.
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AMP to Recognize Eric Lander with 2016 Award for Excellence in Molecular Diagnostics

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.
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AMP Establishes New Standard for Clinical Utility of Molecular Diagnostics for Inherited Diseases and Cancer

A new report in The Journal of Molecular Diagnostics recognizes the value of testing procedures and promotes paradigm corrections to drive widespread adoption of a more proactive, patient-centered approach to modern healthcare.
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View the Report (AMP Reports are free to members and non-members!)

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AMP NEWS: AMP Announces Results of 2016 Leadership Elections

The Association for Molecular Pathology (AMP) today announced the results of its 2016 Leadership Elections. AMP is an organization driven by the dedication of its volunteers and looks forward to working with these newly elected leaders.

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POLICY ALERT: AMP Looks Forward to Working with FDA on Guidance for NGS-Based Tests

The Association for Molecular Pathology (AMP) 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 released on July 6th, 2016.

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NOW CLOSED: 2016 CAP/IASLC/AMP Lung Biomarkers Public Open Comment Period

Association for Molecular Pathology (AMP) in partnership with the College of American Pathologists (CAP) and the International Association for the Study of Lung Cancer (IASLC) is pleased to announce a public open comment period for draft recommendations developed during the update and revision of the evidence-based recommendations originally published in Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Guideline from the CAP, the IASLC, and the AMP
Open Comment Period CLOSED August 2nd. Look for updates on this project in the coming months!

More Information

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Registration & Housing Now Available - AMP 2016 Annual Meeting

AMP is now accepting registrations and housing reservations for the Annual Meeting! Register by September 9th and save!

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Click here for Housing Information


An Update from AMP Advocacy: Read the latest issue of The ChAMPion

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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AMP Releases Results from 2015 Genomic Sequencing Procedure Microcosting and Health Economic Cost-Impact Analyses

"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."

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View the Report

View the evaluation tools and tutorial


AMP Issues Statement Regarding FDA Letters to Two Texas Hospitals about Rapid Detection Zika Test

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.

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AMPlifications - All Molecular, All the Time

Get a glimpse of AMP's recent work in education, innovation, and advocacy for molecular diagnostics.

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Introducing AMP's New Policy Newsletter - The ChAMPion

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

AMP Updates Pathology Residency Curriculum Recommendations

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.

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View the Curriculum


AMP Responds to FDA Report on Oversight of Laboratory Developed Procedures (LDPs)

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.

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View AMP's Analysis of the Report


AMP Endorses the Clinical Pharmacogenetics Implementation Consortium (CPIC)

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.

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AMP Submits Written Testimony on Draft Legislation of LDPs

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.

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View AMP's Testimony

View AMP's CLIA Modernization Proposal


AMP Hosts Symposium on Coding, Coverage, and Reimbursement of Molecular Diagnostic Tests

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.

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Congressman Michael Burgess, MD, Speaks at Session on CLIA Modernization

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.

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