Latest News

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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 AMP plans on submitting formal comments to the two new draft guidance documents, "Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline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.

• share
• favorite_border

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.”

• share
• favorite_border

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).

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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).

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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.

• share
• favorite_border

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