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2014

11/19/2014

AMP Announces Award Winners

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11/14/2014

AMP Establishes Informatics Subdivision

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10/23/2014

AMP Adds Late-Breaking Session on LDPs Oversight and Regulation

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7/31/14

AMP Voices Concern with U.S. FDA Anticipated Details of Laboratory Developed Test Draft Guidance

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4/30/14

Francis S. Collins, MD, PhD, to Speak at AMP 2014 Annual Meeting

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4/23/14

AMP Celebrates the Contributions of Medical Laboratory Professionals during Lab Week 2014

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4/22/14

AMP Publishes Curriculum Recommendations for Medical Laboratory Scientists

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2013

12/18/13

AMP Releases White Paper on LDTs - Coins New Term

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11/4/13

AMP Announces Annual Meeting Highlights

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9/15/13

AMP Announces Award Recipients for 2013

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6/18/13

AMP Joins the Federation of American Societies for Experimental Biology

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6/13/13

AMP Celebrates U.S. Supreme Court Decision on AMP v Myriad

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5/10/2013
Professional Societies Delineate Concerns, Offer Recommendations Regarding Interim Pricing for Molecular Tests
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4/3/13
CAP / IASLC / AMP Release Lung Biomarker Guideline
Advances in Molecular Testing Offer New Hope for Lung Cancer Patients
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3/20/13

AMP Releases Proposal Addressing CPT Coding for GSAs

Report to AMA documents the challenges, related technology, and proposed coding scheme for GSAs

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2012

10/18/12

AMP Publishes Report on NGS

Report provides overview of possibilities, challenges, and applications of next-generation sequencing

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9/26/12

AMP Appeals Breast Cancer Gene Patent Case to U.S. Supreme Court
Case Challenges Patents as Dangerous Roadblock to Patient Care, Medical Innovation

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6/12/12

AMP Receives 40% Increase in Abstract Submissions

The record-breaking number of abstract submissions for the AMP 2012 Annual Meeting on Genomic Medicine is consistent with the increased number of exhibiting companies and anticipated number of attendees.

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5/22/12
AMP Developing a CPT Coding Proposal for Next Generation Sequencing

Proposal to be completed by the end of June and released for feedback from stakeholders in the laboratory and payer community before submission of a formal proposal to the AMA CPT Editorial Panel.
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5/2/2012
AMP Forms Working Group to Further Consider Oversight of Lab Tests

The goal of the group is to produce a white paper that will outline the key issues, and provide AMP's recommendations for future LDT oversight.
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3/27/2012
AMP Optimistic in Suit to invalidate Patents on Breast Cancer Genes
AMP is optimistic that it will ultimately prevail in its lawsuit to invalidate patents on two genes that are known to cause breast cancer. >>Download Entire Press Release

3/21/2012
AMP Applauds Supreme Court Ruling: Sees Win for Patients and Personalized Medicine
AMP is encouraged by the Court's recognition that Prometheus patents neither promote the advancement of medical practice, nor benefit patient care.
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2/16/2012
AMP Requests Moratorium on Human Gene Patenting
AMP testified at the U.S. Patent and Trademark Office hearing regarding patents on human genes.
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2/6/2012
New Governance Structure Approved by AMP Membership
AMP adopts change in governance structure as part of newly implemented strategic plan.
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2011

12/13/2011
U.S. Supreme Court Petitioned to Review AMP, et al. Lawsuit on Gene Patents
AMP is optimistic the Supreme Court will follow its precedents that render natural products, natural laws, and natural phenomena ineligible for patent protection.
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11/22/2011
AMP Responds to NIH Proteomics Patent
AMP responded to the NIH Proteomics Patent, opposing their proposal to exclusively license the subject matter of a cancer-related proteonomics patent application filed by the Agency.
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10/25/2011
AMP Comments on Proposed Changes to the Common Rule
AMP submitted comments to the DHHS calling for language that identifies biospecimen activities to be part of clinical care and the practice of medicine...
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10/12/2011
AMP Comments to FDA Companion Dx Draft Guidelines
AMP submitted comments to the FDA regarding the FDA’s “Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices”.
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9/26/11
AMP Comments to NIH about proposed GTR
AMP voiced concerns about the proposed Genetic Testing Rregistry (GTR) as currently designed. Requested that NIH take clarity and cost into consideration.
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9/21/11
AMP Announces 2011 Annual Meeting Program
AMP announced the program of events for its Annual Meeting, being held November 17-19 at the Gaylord Texan Hotel and Convention Center in Grapevine, Texas.
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8/30/2011
AMP Responds to FDA RUO/IUO FAQ's
AMP submitted comments to the FDA on the draft guidance document titled, “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.”
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6/30/2011
AMP Appoints Mary Steele Williams to Position of Executive Director
AMP appointed Mary Steele Williams, MNA, MT(ASCP)SM to the position of Executive Director. This move is indicative of the tremendous growth experienced by the 17 year-old Association. The outgoing Executive Officer, Mark E. Sobel, MD, PhD, a founding member and past President, served for ten years as AMP’s part time Executive Officer and steered it to its current prominence as the voice of molecular pathology.
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6/23/2011
AMP Comments at FDA Meeting on Next Generation Sequencing
On behalf of AMP, Dr. Elaine Lyon gave public comments at the US Food and Drug Administration's (FDA) meeting on "Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity." As they begin developing their program to evaluate sequencing based diagnostics, AMP advised FDA officials on many important considerations for evaluating analytical validity.
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5/16/2011
AMP Releases Statement on Diagnostics in Drug Labels
AMP released its new position statement on reference to diagnostic tests in drug labels. AMP's statement outlines the organization's commitment to providing high quality medical care and ensuring patients have access to the most appropriate diagnostic tests based on their clinical presentation.
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2010

7/29/10
AMP Responds to Genetic Test Registry Request for Information
Bethesda, MD (July 29, 2010): Today, the Association for Molecular Pathology (AMP) submitted written comments in response to the Request for Information made by the National Institutes of Health (NIH) for its Genetic Test Registry (GTR). AMP conducted a survey of its membership to formulate a comprehensive response to the RFI.
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7/20/10
AMP Presents at FDA Meeting on Regulating Diagnostics
College Park, MD (July 20, 2010): The Association for Molecular Pathology (AMP) participated in the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) public meeting on the oversight of laboratory developed tests (LDTs). Dr. Karen Mann, President of AMP, served on the second panel of the meeting titled, Clinical Laboratory Challenges. Additionally, Dr. Elaine Lyon, Chair of the AMP Professional Relations Committee, presented public comments.
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6/30/10
AMP Comments at FDA Meeting on Array-Based Tests
Bethesda, MD (June 30, 2010): Today, the Association for Molecular Pathology (AMP) presented comments at the US Food & Drug Administration’s public meeting on array-based cytogenetic tests. The FDA convened the meeting to seek answers to more than a dozen questions they had on how to evaluate the performance, interpret results and report findings of array-based cytogenetic tests for copy number variation (CNV).
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6/29/10
AMP Submits Comments on SACGHS Report
Washington, DC (June 29, 2010): Today, the Association for Molecular Pathology (AMP) submitted comments on the Draft Report of the Secretary's Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers.
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6/24/10

AMP Asks FDA to Address Berriers to Device Innovation
Washington, DC (June 25, 2010): Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic
Tests.
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6/15/10
AMP Commends SACGHS Whole Genome Sequencing Focus, Raises Ethical Questions and Forms Working Group on Whole Genome Analysis
Today, the Association for Molecular Pathology (AMP) presented public comments to the Secretary's Advisory Committee on Genetics, Health and Society (SACHGS) meeting focused on whole genome sequencing. In anticipation of advances in sequencing and its incorporation into clinical practice, AMP raised ethical and laboratory practice concerns for the Committee's consideration.
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5/14/10
AMP Cautions Consumers About Direct Access Genetic Testing
In response to recent announcements about consumer genetic tests being made available in retail drugstores, the AMP today reiterated its position that these tests should be provided to the public only through the services of appropriate health care professionals that order tests from CLIA-certified laboratories.
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3/31/10

The Association for Molecular Pathology Celebrates Ruling in DNA Patent Case
The Association for Molecular Pathology (AMP) applauds US District Judge Robert Sweet's ruling in favor of the plaintiffs in the lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. "This is a landmark decision that has the potential to dramatically improve patient access to genetic testing. It is a boon to personalized medicine in the purest sense as nothing is more personal than one's genetic makeup. This judgment removes numerous barriers and impediments to clinical research, testing, and innovation since patented genes cannot be invented around, and has implications for how we evaluate each and every patient's genetic information" said Dr. Karen Mann, AMP President.
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2/9/10

AMP Applauds SACGHS on Release of Final Report on DNA Patents
The Association for Molecular Pathology (AMP) commends the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) for its thoughtful, deliberative exploration into the challenges of gene patents and is hopeful that the Secretary of the Department of Health and Human Services will act swiftly to adopt measures that would protect patients from the harms of gene patents and exclusive licensing practices.
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1/28/10

AMP Releases Statement on Oversight of Laboratory Tests
The Association for Molecular Pathology releases a position statement on the oversight of laboratory developed tests to foster discussion among stakeholders and meets wit the Food & Drug Administration.
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2009

11/9/09

MEDIA ALERT:  Association for Molecular Pathology's 15th Annual Meeting and Exhibits
The Association for Molecular Pathology (AMP) invites the media to follow its upcoming 2009 Annual Meeting and Exhibits and learn about the latest advances in clinical molecular diagnostics.
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10/14/09

Association for Molecular Pathology Commends SACGHS on their DNA Patent Report

The Association for Molecular Pathology (AMP) provided comments at the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) meeting on Oct. 8.  AMP opposes the patenting of all naturally occurring genetic material and has signed on as a lead plaintiff in the ACLU case challenging Myriad Genetics' patents on the BRCA 1 and BRCA 2 genes.  AMP thanked SACGHS for studying how both patents and restrictive licensing limit patient access and potentially reduce the quality of tests.

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6/29/09

Association for Molecular Pathology Outlines Key Principles for Health Care Reform

The Association for Molecular Pathology today announced a set of key principles to guide the organization's public policy advocacy amid current effort in Congress and the Obama administration to reform the nation's health care system. These core principles specifically address the practice of clinical laboratory medicine and the use of molecular-based diagnostic tests.

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6/12/09

Association for Molecular Pathology Urges Comprehensive Measures to Incorporate Molecular Diagnostic Tests Into Comparative Effectiveness Research
The Association for Molecular Pathology (AMP) today released the text of a comment letter it has provided to the Federal Coordinating Council for Comparative Effectiveness Research (CER) in which AMP sets forth its recommendations for priority areas on which to focus CER activities.
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6/12/09

Association for Molecular Pathology Comments to the SACGHS
In pubic comments given today before the Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society (SACGHS), the Association for Molecular Pathology (AMP) addressed three areas: Comparative Effectiveness Research (CER), evidence for coverage of genetic and genomic tests, and gene patents.
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5/21/2009

Association for Molecular Pathology Urges Secretary's Advisory Committee to Give Greater Consideration to the Negative Impact of Gene Patents and Restrictive Licensing Practices on Public Health
AMP Comments on Draft Report on Gene Patents and Licensing by the Secretary's Advisory Committee on Genetics, Health and Society
Washington, DC - May 21, 2009 - The Association for Molecular Pathology today urged the Secretary of Health and Human Services' Advisory Committee on Genetics, Health and Society to more definitively explore the negative impact on public health that derives from gene patents and from exclusive and restrictive licensing practices as part of its draft report, Gene Patents and Licensing and Their Impact on Patient Access to Genetic Tests.
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5/13/2009

Association for Molecular Pathology Joins the American Civil Liberties Union to Challenge the Constitutionality of Gene Patents
Washington, DC - May 13, 2009 - The Association for Molecular Pathology (AMP) announced today that it is working with the American Civil Liberties Union (ACLU) and the Public Patent Foundation to bring a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and should be invalidated. Individuals with certain mutations long these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers.
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5/5/2009

The Association for Molecular Pathology calls for enhanced communication and collaboration between state and local public health laboratories and molecular pathology laboratories to combat the swine influenza A (H1N1) outbreak
Bethesda, MD - April 30, 2009 -- As the nation faces the ongoing public health challenges of a new circulating strain of influenza, the Association for Molecular Pathology (AMP) encourages close collaboration between molecular diagnostics laboratories, CDC , and public health laboratories to ensure prompt diagnosis and timely surveillance of the outbreak. AMP's members are physicians, doctoral scientists and medical technologists with expertise in developing, validating and providing laboratory tests based on molecular methods. They have the education and training to offer high quality molecular diagnostic testing for influenza and extensive experience providing clinical testing for seasonal influenza.
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2008

12/1/2008
Association of Molecular Pathology Urges an End to the Practice of Granting Patents on Single Genes and Gene Sequences in the Human Genome and to Exclusive Licenses to Genetic Discoveries
In newly adopted Position Statement, group also calls for stakeholders to develop more innovative models of intellectual property to encourage innovation and improve patient access to improved molecular tests
WASHINGTON, DC - December 1, 2008 - In a statement delivered today before the Secretary of Health and Human Services' Advisory Committee of Genetics, Health and Society (SACGHS), the Association of Molecular Pathology (AMP) urged an end to the practice of granting patents on single genes, sequences of the genome or correlations between genetic variations and biological states. AMP also encouraged groups that currently hold gene patents, including higher educational and research institutions, not to grant exclusive licenses to access these patents...
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10/27/2008
Association for Molecular Pathology holds 14th Annual Meeting and Exhibits, October 29 - November 2, 2008 in Grapevine, TX
Bethesda, MD - October 27, 2008 - The Association for Molecular Pathology (AMP) 14th Annual Meeting and Exhibits will be held October 29 - November 2, 2008 at the Gaylord Texan Resort and Convention Center in Grapevine, Texas. This meeting will feature three days of plenary sessions and workshops in hematopathology, infectious diseases, inherited genetic diseases, solid tumors, and current technical topics presented by leading scientists and diagnosticians in the field of molecular diagnostics...
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8/25/2008
Association for Molecular Pathology to Increase Public Policy Advocacy Role
Organization Retains HealthFutures as Government Relations Consultant

BETHESDA, MD - July 1, 2008 -- The Association for Molecular Pathology (AMP) announced today plans to significantly increase its activity and visibility in the federal public policy arena for 2008 and beyond. In response to a range of new issues that will impact the emerging field of molecular diagnostics, and in preparation for a national dialogue on health care reform likely to take place in the next presidential administration, the organization will be more actively engaged with policy makers in Congress and the Executive Branch on legislative, regulatory and policy matters...
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2007

4/03/2007
Daniel H. Farkas, Ph.D. to Receive 2007 Leadership Award From Association for Molecular Pathology
Grand Rapids, Mich. April 3, 2007 - The Center for Molecular Medicine (CMM) today announced that Executive Director Daniel H. Farkas, Ph.D., has been named the recipient of the 2007 Leadership Award from the Association for Molecular Pathology (AMP).
The AMP was founded in 1995 to provide structure and leadership to the then-emerging field of diagnostic molecular pathology. Since 2005, the organization has honored an AMP member with its Leadership Award, based on that member's accomplishments and notable contributions to the vision and direction of both AMP and the field of diagnostic molecular pathology...
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