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Released: 28-May-2020 8:00 AM EDT
Association for Molecular Pathology Releases Preliminary Results to Nationwide SARS-CoV-2 Molecular Testing Survey
Association for Molecular Pathology

The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today released the preliminary results of its April 2020 SARS-CoV-2 Testing Survey for clinical laboratories. The anonymous survey was created and administered to document clinical laboratory efforts and experiences. The results will be used to help inform future advocacy and clinical practice programs related to pandemic responses.

Released: 5-May-2020 3:40 PM EDT
AMP Recommends Minimum Set of Pharmacogenetic Alleles to Help Standardize Clinical Genotyping Testing for Warfarin Response
Association for Molecular Pathology

AMP has published consensus, evidence-based recommendations to aid in the design, validation and interpretation of clinical genotyping tests for the prediction of warfarin response. The manuscript, “Recommendations for Clinical Warfarin Sensitivity Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists,” was released online ahead of publication in The Journal of Molecular Diagnostics.

Released: 4-May-2020 12:55 PM EDT
AMP Expresses Support for Citizen Petition from the Coalition to Preserve Access to Pharmacogenomics Information
Association for Molecular Pathology

AMP has submitted a formal response in support of the Citizen Petition from Hyman, Phelps & McNamara, P.C. on behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information. The response builds on AMP’s PGx Best Practices Statement and includes a series of recommendations that will rectify recent FDA actions, which have suppressed important patient safety information.

Released: 18-Mar-2020 9:50 AM EDT
Association for Molecular Pathology Commends Senator Rand Paul for Introducing the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020
Association for Molecular Pathology

AMP applauds US Senator Rand Paul (R-KY) for introducing new legislation to allow molecular pathology professionals to continue advancing and offering laboratory developed testing procedures (LDPs) for patient care. The Verified Innovative Testing in American Laboratories (VITAL) Act of 2020 clarifies the federal regulatory authority over LDPs and encourages the modernization of the existing Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare and Medicaid Services(CMS). The legislation was designed to enhance transparency, preserve innovation and ensure widespread patient access to essential medical services.

Released: 16-Mar-2020 9:00 AM EDT
Association for Molecular Pathology Calls on Senate to Close Coverage Gaps for Clinical Laboratory Testing in Families First Coronavirus Response Act
Association for Molecular Pathology

The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today released a statement on H.R. 6201, the Families First Coronavirus Response Act, as passed by the House of Representatives on March 14, 2020.

Released: 19-Sep-2019 9:00 AM EDT
Association for Molecular Pathology Announces 2019 Award Recipients
Association for Molecular Pathology

AMP has announced the recipients of this year’s Award for Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership Award and Meritorious Service Award. These prestigious accolades will be presented this November during AMP’s 25th Annual Meeting & Expo in Baltimore, Maryland.

Released: 4-Sep-2019 9:45 AM EDT
AMP Recommends Clinical Pharmacogenomic Testing Best Practices to Preserve Broad Access and Improve Patient Care
Association for Molecular Pathology

AMP has published a new position statement for pharmacogenomic testing. Based on a recent assessment of the current market landscape, the statement includes a list of criteria for laboratories to follow for these types of tests to ensure responsible use, preserve broad access and improve patient care.

Released: 10-Jun-2019 11:05 AM EDT
AMP Bolsters Position on Consumer Genomic Testing
Association for Molecular Pathology

AMP has revised its official position for all consumer genomic testing. Based on a recent assessment of the current market landscape and privacy best practices, the latest position statement features an expanded list of conditions that must be met before AMP can support a clinically-meaningful test.

Released: 4-Jun-2019 10:50 AM EDT
Association for Molecular Pathology Expresses Serious Concerns with Congress’ Attempt to Resurrect Human Gene Patenting Debate and Reverse Settled Supreme Court Ruling
Association for Molecular Pathology

AMP has expressed serious concerns with Congress’ recent proposal to amend Section 101 of the Patent Act. If enacted, the draft legislation would overturn 150 years of patent case law and permit patenting of human genes and naturally-occurring associations between genes and diseases.

Released: 9-May-2019 10:05 AM EDT
AMP Recommends Minimum Set of Alleles for All Clinical CYP2C9 Genotyping Testing
Association for Molecular Pathology

A new joint report from AMP and CAP shares consensus, evidence-based recommendations to aid in the design and validation of clinical CYP2C9 assays, promote standardization of testing across different laboratories and improve patient care.

Released: 1-Feb-2019 12:00 PM EST
More than 60 Leading Health Care Organizations Call on CMS to Maintain Coverage for Medically Necessary Cancer Testing
Association for Molecular Pathology

Leading health care companies and organizations representing patients, providers, academic medical centers, laboratories, and diagnostic manufacturers urged the Centers for Medicare and Medicaid Services to revise its interpretation of the National Coverage Determination for Next Generation Sequencing.

Released: 22-Aug-2018 2:05 PM EDT
Association for Molecular Pathology Announces 2018 Award Recipients
Association for Molecular Pathology

AMP has announced the recipients of this year’s Award for Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership Award and Meritorious Service Award. These prestigious accolades will be presented in November during the AMP 2018 Annual Meeting & Expo in San Antonio, Texas.

Released: 21-Aug-2018 3:05 PM EDT
AMP Addresses Clinical Relevance of DNA Variants in Chronic Myeloid Neoplasms
Association for Molecular Pathology

AMP has published consensus, evidence-based recommendations to aid clinical laboratory professionals with the management of most Chronic Myeloid Neoplasms (CMNs) and development of high-throughput pan-myeloid sequencing testing panels.

Released: 27-Feb-2018 11:00 AM EST
AMP Publishes Recommendations for Clinical CYP2C19 Genotyping Allele Selection
Association for Molecular Pathology

AMP has published consensus, evidence-based recommendations to aid clinical laboratory professionals when designing and validating clinical CYP2C19 assays, promote standardization of testing across different laboratories and complement existing clinical guidelines.

Released: 16-Nov-2017 8:00 AM EST
AMP Issues Consensus Clinical Validation Guideline Recommendations for Next-Generation Sequencing Bioinformatics Pipelines
Association for Molecular Pathology

The Association for Molecular Pathology, the premier global, non-profit molecular diagnostics professional society, today published 17 consensus recommendations to help clinical laboratory professionals achieve high-quality sequencing results and deliver better patient care.

Released: 13-Sep-2017 1:05 PM EDT
The Association for Molecular Pathology Announces 2017 Award Recipients
Association for Molecular Pathology

September 5, 2017 – The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostics professionals, today announced the recipients of this year’s Jeffrey A. Kant Leadership and AMP Meritorious Service Awards.

Released: 19-Jul-2017 9:05 AM EDT
The Association for Molecular Pathology Announces Results of 2017 Leadership Elections
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) has announced the results of its 2017 Leadership Elections.

Released: 22-Mar-2017 11:05 AM EDT
AMP Issues Best Practice Guidelines for Next-Generation Sequencing-Based Oncology Panel Validation
Association for Molecular Pathology

AMP has published consensus recommendations that will help clinical laboratory professionals achieve high-quality sequencing results and deliver better care for cancer patients

Released: 16-Dec-2016 11:05 AM EST
AMP Issues New Joint Guidelines to Standardize Interpretation and Reporting of Sequence Variants in Cancer
Association for Molecular Pathology

AMP has published guideline recommendations for both clinical laboratory professionals and oncologists that assess the status of next-generation sequencing (NGS)-based cancer tests and establish standardized classification, annotation, interpretation, and reporting conventions for somatic sequence variants.

Released: 21-Nov-2016 1:20 PM EST
AMP Applauds FDA’s Decision to Delay Final Regulatory Guidance for Laboratory Developed Procedures
Association for Molecular Pathology

AMP Applauds FDA’s Decision to Delay Final Regulatory Guidance for Laboratory Developed Procedures

Released: 19-Oct-2016 9:05 AM EDT
The Association for Molecular Pathology Explores New Technological Advancements to Improve Diagnosis and Optimize Treatment Selection for Invasive Infectious Diseases
Association for Molecular Pathology

AMP has announced a new report that examines how sophisticated technology advancements are being implemented to improve diagnosis and optimize treatment selection for multiple invasive, opportunistic and often deadly infectious diseases.

Released: 26-Sep-2016 12:05 PM EDT
Association for Molecular Pathology Announces 2016 Award Recipients
Association for Molecular Pathology

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.

Released: 22-Sep-2016 8:05 AM EDT
Association for Molecular Pathology Appreciates Opportunity to Discuss with Congressional Leaders How Laboratory Developed Procedures Benefit Patient Care
Association for Molecular Pathology

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.

Released: 19-Sep-2016 5:05 PM EDT
Media Alert: Association for Molecular Pathology to Participate in Senate Hearing and Congressional Briefing to Educate Lawmakers on Laboratory Developed Procedures and their Benefit to Patient Care
Association for Molecular Pathology

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.

Released: 14-Sep-2016 11:05 AM EDT
Media Alert: Complimentary Media Registrations for Upcoming Association for Molecular Pathology 2016 Annual Meeting
Association for Molecular Pathology

Complimentary media registration packages are available for AMP's upcoming 2016 Annual Meeting in Charlotte, North Carolina.

Released: 8-Sep-2016 9:05 AM EDT
AMP to Recognize Eric Lander with 2016 Award for Excellence in Molecular Diagnostics
Association for Molecular Pathology

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.

Released: 17-Aug-2016 9:05 AM EDT
The Association for Molecular Pathology Establishes New Standard for Clinical Utility of Molecular Diagnostics for Inherited Diseases and Cancer
Association for Molecular Pathology

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.

Released: 7-Jul-2016 6:00 PM EDT
AMP Looks Forward to Working with FDA on Guidance for Next-Generation Sequencing-Based Tests
Association for Molecular Pathology

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.

Released: 28-Jun-2016 11:05 AM EDT
International Lung Cancer Experts Seek Public Comments on Revised Molecular Testing Guideline to Improve Patient Selection and Targeted Therapies
Association for Molecular Pathology

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.”

Released: 13-Apr-2016 2:05 PM EDT
AMP Releases Results from 2015 Genomic Sequencing Procedure Microcosting and Health Economic Cost-Impact Analyses
Association for Molecular Pathology

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).

Released: 15-Mar-2016 2:05 PM EDT
AMP Issues Statement Regarding FDA Letter to Texas Children’s Hospital and Houston Methodist Hospital About Rapid Detection Zika Test
Association for Molecular Pathology

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.

Released: 5-Feb-2016 11:05 AM EST
AMP Updates Pathology Residency Curriculum Recommendations
Association for Molecular Pathology

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.

Released: 15-Dec-2015 8:05 PM EST
AMP Responds to FDA Report on Oversight of Laboratory Developed Testing Procedures
Association for Molecular Pathology

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.

Released: 18-Nov-2015 10:05 AM EST
AMP Submits Written Testimony for Hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations”
Association for Molecular Pathology

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).

Released: 10-Nov-2015 12:05 PM EST
AMP Symposium on Coding, Coverage, and Reimbursement of Molecular Diagnostic Tests
Association for Molecular Pathology

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.

Released: 9-Nov-2015 1:05 PM EST
Congressman Michael Burgess, MD, Speaks at Session on CLIA Modernization of Laboratory Developed Procedures at AMP Annual Meeting
Association for Molecular Pathology

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.

Released: 15-Oct-2015 2:05 PM EDT
The Association for Molecular Pathology Announces 2015 Award Recipients
Association for Molecular Pathology

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.

Released: 1-Oct-2015 12:05 PM EDT
The Journal of Molecular Diagnostics Publishes Article on Next Generation Sequencing for Diagnosis and Management of Infectious Diseases
Association for Molecular Pathology

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.

Released: 4-Aug-2015 3:05 PM EDT
AMP Meets with Senate HELP Committee and Presents a CLIA Modernization Proposal
Association for Molecular Pathology

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.

Released: 4-Jun-2015 12:05 PM EDT
The Evolving Role of the Laboratory Professional in the Age of Genomic Sequencing
Association for Molecular Pathology

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.

Released: 21-May-2015 2:05 PM EDT
The Association for Molecular Pathology Announces International Affairs Committee
Association for Molecular Pathology

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.

Released: 22-Apr-2015 10:05 AM EDT
The Association for Molecular Pathology Compiles Current Research on Liquid Biopsy
Association for Molecular Pathology

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.

Released: 30-Mar-2015 12:00 PM EDT
ASCP, CAP, AMP, and ASCO Issue Draft Colorectal Cancer Molecular Marker Testing Guideline and Announce Opening of Public Comment Period
Association for Molecular Pathology

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.

Released: 23-Mar-2015 9:00 AM EDT
AMP Submits Written Comments to FDA on Next Generation Sequencing Regulation
Association for Molecular Pathology

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.

Released: 4-Mar-2015 11:15 AM EST
AMP Launches Micro-Costing and Health Economic Evaluation Tools for Genome Sequencing Procedures
Association for Molecular Pathology

AMP releases cost analysis results and health economic evaluation models for several genomic sequencing procedure codes.

Released: 20-Feb-2015 2:00 PM EST
AMP Delivers Oral Comments at FDA Workshop on Optimizing Regulatory Oversight of Next Generation Sequencing Diagnostic Tests
Association for Molecular Pathology

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.

Released: 8-Jan-2015 4:00 PM EST
AMP Releases “Molecular Diagnostic Perfect Storm” Paper Addressing the Convergence of Regulatory and Reimbursement Forces that Threaten Patient Care
Association for Molecular Pathology

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.

Released: 8-Jan-2015 2:35 PM EST
AMP has Strong Presence at FDA Workshop on LDTs, Delivers Message of Optimizing Patient Care through Molecular Diagnostics
Association for Molecular Pathology

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.

Released: 19-Nov-2014 9:30 AM EST
The Association for Molecular Pathology Announces 2014 Award Recipients
Association for Molecular Pathology

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.


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