Latest News from: Association for Molecular Pathology

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Released: 27-Mar-2012 12:35 PM EDT
AMP Optimistic in Suit to invalidate Patents on Breast Cancer Genes
Association for Molecular Pathology

Now that the Supreme Court has remanded Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al. (AMP v. Myriad) to the Court of Appeals for the Federal Circuit for further consideration, AMP is optimistic that it will ultimately prevail in its lawsuit to invalidate patents on two genes that are known to cause breast cancer.

Released: 21-Mar-2012 1:30 PM EDT
AMP Applauds Supreme Court Ruling: Sees Win for Patients and Personalized Medicine
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) applauds the U.S. Supreme Court’s ruling today in the case of Mayo Collaborative Services v. Prometheus Laboratories as a victory for patients and for the advancement of personalized medicine.

Released: 16-Feb-2012 1:00 PM EST
AMP Testifies at USPTO
Association for Molecular Pathology

AMP presented testimony to the U.S. Patent and Trademark Office requesting moratorium on human gene patenting.

Released: 6-Feb-2012 10:00 AM EST
New Governance Structure Approved by AMP Membership
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) adopts change in governance structure as part of newly implemented strategic plan.

Released: 15-Dec-2011 12:25 PM EST
U.S. Supreme Court Petitioned to Review Association for Molecular Pathology, et al. Lawsuit on Gene Patents
Association for Molecular Pathology

The American Civil Liberties Union and the Public Patent Foundation have petitioned the U.S. Supreme Court to hear Association for Molecular Pathology v. U.S. Patent and Trademark Office, a case that challenges the validity of patents on two human genes associated with hereditary breast and ovarian cancer.

Released: 22-Nov-2011 8:30 AM EST
AMP Opposes Exclusive Licensing of NIH Proteomics Patent
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) opposed the National Institutes of Health (NIH) proposal to exclusively license the subject matter of a cancer-related proteonomics patent application filed by the Agency.

Released: 18-Nov-2011 6:30 PM EST
AMP Honors Leaders at 2011 Annual Meeting
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) today announced the 2011 AMP Award winners during the Association’s Annual Meeting in Dallas.

Released: 18-Nov-2011 3:20 PM EST
AMP Announces Completion of Strategic Plan For Era of Personalized Medicine
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) today announced the AMP Council’s unanimous approval of a strategic plan intended to guide the organization over the next four years.

Released: 27-Oct-2011 5:25 PM EDT
Proposed NIH Genetic Testing Registry Lacks Clarity, Understates Costs
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) submitted comments to the National Institutes of Health (NIH), in which the Association voiced concerns about the proposed Genetic Testing Registry (GTR) as currently designed, and requested that NIH take clarity and cost into consideration when designing a test registry.

Released: 26-Oct-2011 9:30 AM EDT
FDA Draft Guidance Should Focus on “Companion Biomarkers” and Provide for Use of LDTs
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) submitted comments to the Food and Drug Administration (FDA) regarding the FDA’s “Draft Guidance for Industry and Food and Drug Administration Staff – In Vitro Companion Diagnostic Devices”.

Released: 25-Oct-2011 4:50 PM EDT
AMP Comments on Proposed Changes to the Common Rule
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) expresses concern that the proposed rule’s determination that biospecimens cannot be de-identified will limit validation of clinical tests.

Released: 21-Sep-2011 3:00 PM EDT
Association for Molecular PathologyAnnounces 2011 Annual Meeting Program
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) has 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.

Released: 30-Aug-2011 1:30 PM EDT
FDA Draft Guidance Document May Limit Patient Access to Tests
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.”

Released: 29-Aug-2011 9:00 AM EDT
Association for Molecular Pathology Names Lambert, Edwards & Associates as Public Relations Agency of Record
Association for Molecular Pathology

The Association for Molecular Pathology (AMP), an international medical professional association dedicated to the advancement, practice, and research of clinical molecular laboratory medicine, has retained Lambert, Edwards & Associates (LE&A) to provide public relations services for the Association and the rapidly growing field of molecular diagnostics.

Released: 29-Jul-2011 5:00 PM EDT
Divided Appeals Court Rules on BRCA Case
Association for Molecular Pathology

In a 2-1 decision, a federal appeals court today partially reversed a lower court’s ruling in AMP’s case that challenges patents on two human genes associated with hereditary breast and ovarian cancer.

Released: 30-Jun-2011 1:05 PM EDT
AMP Appoints Mary Steele Williams to Position of Executive Director
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) has appointed Mary Steele Williams, MNA, MT(ASCP)SM to the position of Executive Director.

Released: 23-Jun-2011 7:00 AM EDT
AMP Comments at FDA Meeting on Next Generation Sequencing
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) gave public comments at the US Food and Drug Administration’s (FDA) meeting on next generation sequencing and called on officials to partner with professional associations as they develop a program to evaluate sequencing based diagnostics.

Released: 16-May-2011 9:00 AM EDT
AMP Releases Statement on Diagnostics in Drug Labels
Association for Molecular Pathology

Today, at a meeting with the Food and Drug Administration, the Association for Molecular Pathology (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.

Released: 9-Nov-2010 3:30 PM EST
Association for Molecular Pathology’s 16th Annual Meeting and Exhibits
Association for Molecular Pathology

AMP invites the media to attend its upcoming 2010 Annual Meeting and Exhibits and learn about the latest advances in clinical molecular diagnostics. The four-day event will feature more than 100 corporate exhibits, as well as many cutting-edge lectures, workshops and plenary sessions.

Released: 29-Jul-2010 2:00 PM EDT
AMP Responds to Genetic Test Registry Request for Information
Association for Molecular Pathology

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.

Released: 20-Jul-2010 2:45 PM EDT
AMP Presents at FDA Meeting on Regulating Diagnostics
Association for Molecular Pathology

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.

Released: 30-Jun-2010 12:00 PM EDT
AMP Comments at FDA Meeting on Array-Based Tests
Association for Molecular Pathology

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).

Released: 29-Jun-2010 1:20 PM EDT
AMP Submits Comments on SACGHS Report
Association for Molecular Pathology

Yesterday, 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.

Released: 25-Jun-2010 2:55 PM EDT
AMP Asks FDA to Address Barriers to Device Innovation
Association for Molecular Pathology

AMP commends the Federal departments and agencies that compose the Council on Medical Device Innovation for making efforts to identify and remove barriers to innovation and progress in transitioning basic and transitional research findings into routine clinical practice. In its remarks, AMP identified three barriers that impede the path to FDA clearance or approval for diagnostic tests and reduce the motivation to submit some medically useful tests for review.

Released: 16-Jun-2010 9:00 AM EDT
AMP Commends SACGHS Whole Genome Sequencing Focus, Raises Ethical Questions and Forms Working Group on Whole Genome Analysis
Association for Molecular Pathology

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.

Released: 14-May-2010 2:00 PM EDT
AMP Cautions Consumers About Direct Access Genetic Testing
Association for Molecular Pathology

In response to recent announcements about consumer genetic tests being made available in retail drugstores, the Association for Molecular Pathology (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 laboratories that are certified by CLIA for highcomplexity testing.

Released: 1-Apr-2010 11:20 AM EDT
AMP Celebrates Ruling in DNA Patent Case
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.

Released: 5-Feb-2010 1:30 PM EST
AMP Applauds SACGHS on Release of Final Report on DNA Patents
Association for Molecular Pathology

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 .

Released: 28-Jan-2010 11:45 AM EST
AMP Releases Statement on Oversight of Laboratory Tests
Association for Molecular Pathology

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.

Released: 9-Nov-2009 4:40 PM EST
AMP’s 15th Annual Meeting and Exhibits
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. The four-day event will feature more than 100 corporate exhibits, as well as many cutting-edge lectures, workshops and plenary sessions.

Released: 14-Oct-2009 11:00 AM EDT
AMP Commends SACGHS on their DNA Patent Report
Association for Molecular Pathology

The Association for Molecular Pathology (AMP) provided comments at the 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.

Released: 1-Sep-2009 8:00 PM EDT
AMP President Updates CDC Committee on H1N1 Testing
Association for Molecular Pathology

Dr. Jan Nowak reports community molecular pathologists’ efforts to confirm suspected cases of H1N1 influenza early in the outbreak and discussed the challenges encountered by the diagnostic community and opportunities to improve access to high quality rapid diagnostic tests for pandemic influenza.

Released: 1-Jul-2009 10:00 AM EDT
AMP Outlines Key Principles for Health Care Reform
Association for Molecular Pathology

AMP Stresses that molecular diagnostic tests are critical in the era of personalized medicine.

Released: 16-Jun-2009 9:00 PM EDT
AMP Urges Inclusion of Molecular Tests In CER
Association for Molecular Pathology

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.

Released: 16-Jun-2009 11:35 AM EDT
Association for Molecular Pathology Comments to SACGHS
Association for Molecular Pathology

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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