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Association for Molecular Pathology

Advancing molecular diagnostics through education, advocacy, and guidelines.

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The Association for Molecular Pathology (AMP) is a volunteer-run professional group for those involved in molecular diagnostics. Founded in 1995, it has over 3,100 members across more than 50 countries. AMP focuses on education, advocacy, and advancing patient care by publishing evidence-based practice guidelines.

History

AMP was formed in 1995 to provide structure and leadership to the emerging field of molecular diagnostics, following discussions and workshops in the late 1980s and early 1990s. At a November 1993 workshop, participants formed working groups that became the initial four subdivisions: Hematopathology, Solid Tumors, Genetics, and Infectious Diseases. Informatics was added as a fifth subdivision in 2012.

Clinical Practice & Patient Care

AMP publishes evidence-based guidelines and freely available reports to provide best practices and recommendations for its rapidly evolving field. It frequently collaborates with organizations such as the College of American Pathologists, American Society of Clinical Oncology, American College of Obstetricians and Gynecologists, and American College of Medical Genetics and Genomics. Guidelines are authored by members elected to the Clinical Practice Committee or appointed by the Board of Directors.

Advocacy

AMP advocates for molecular professionals and patients, working to modernize the regulatory environment for molecular genetics testing in the U.S., which is governed by regulations including the Clinical Laboratory Improvement Act, Centers for Medicare and Medicaid, and the Food and Drug Administration. Through efforts such as the AMP Economics Summit, AMP informs the U.S. Congress and federal agencies on public policy issues affecting molecular pathology, seeking to ensure broad and equitable patient access to testing. Internationally, members advocate for appropriate molecular diagnostic testing in several countries.

AMP was the lead plaintiff in Association for Molecular Pathology v. Myriad Genetics, Inc., a landmark lawsuit challenging gene patents. In June 2013, the U.S. Supreme Court unanimously ruled that naturally occurring DNA segments are not patent eligible merely because they have been isolated, but cDNA is patent eligible.

On the fifth anniversary of the ruling, AMP released a video about its decision to join the case. In August 2024, AMP filed a lawsuit against the FDA (Association for Molecular Pathology v. U.S. Food and Drug Administration) opposing a final rule issued on May 6, 2024, that would regulate laboratory-developed tests as medical devices, citing concerns about negative impacts on patient access, laboratory innovation, and increased costs.

Publications

The Association for Molecular Pathology and the American Society for Investigative Pathology jointly own The Journal of Molecular Diagnostics, which launched in 1999. It ranks first in its field, with a 2021 Impact Factor of 5.341, and publishes original research on molecular diagnostics. Members get free online journal access, discounted publication fees, and free practice guidelines.

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Sources

Compiled from Wikipedia and the sources listed below. Text from Wikipedia is available under CC BY-SA 4.0; this entry is adapted from it.

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