Genetics and Molecular Medicine
Genetic Testing News
Brochure on pharmacogenomics developed by the AMA, Critical Path Institute, and the Arizona Center for Education and Research on Therapeutics
July 5, 2011 - The AMA has teamed with the Critical Path Institute and the Arizona Center for Education and Research on Therapeutics to develop a brochure for health care providers on pharmacogenomics. Pharmacogenomics is the study of genetic variations that influence individual response to drugs. Knowing whether a patient carries any of these genetic variations can help prescribers individualize drug therapy, decrease the chance for adverse drug events, and increase the effectiveness of drugs. The brochure, intended for physicians and other health care providers who may not have extensive experience with pharmacogenomics, introduces the concept using a case-based approach. View an electronic version of the brochure. To request hard copies of the brochure, email pharmacogenomics@ama-assn.org.
Feb. 23, 2011 - In a letter to the Food and Drug Administration (FDA), the AMA called for genetic testing to be conducted under the guidance of a physician, genetic counselor, or other genetics specialist. The letter was sent to the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee regarding direct to consumer genetic tests prior to the panel's hearings on the topic, scheduled for March 8 and 9. Read more.
Gene patents on breast cancer genes ruled invalid
Mar. 29, 2010 – A United States District Court ruled today that the patents held by Myriad Genetics on the breast and ovarian cancer genes BRCA1 and BRCA2 are invalid. The AMA submitted an amicus brief in the case, arguing that gene patents inhibit patient and physician access and hinder technology improvement. Myriad is expected to appeal the ruling.
Clopidogrel label to include warning about reduced effectiveness in patients with genetic variants
Mar. 12, 2010 – A Boxed Warning has been added to the product labeling of clopidogrel (Plavix®), informing health care providers that patients who carry certain variations in CYP2C19 may not derive full therapeutic benefit from the drug. View the updated label.
Warfarin labeling updated with pharmacogenomic dosing rages
Jan. 22, 2010 – The FDA announced today that the warfarin product labeling has been updated. The label now includes expected therapeutic dosing ranges for patients with variations in the genes CYP2C9 and VKORC1. View the new label.
The Genetic Information Nondiscrimination Act signed into law
May 21, 2008 - Thirteen years after being introduced, legislation that protects against genetic discrimination has been signed into law. The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibits health insurers and employers from discriminating on the basis of genetic information. Specifically, GINA prohibits health insurers from using genetic information to determine eligibility or premiums, prohibits insurers and employers from requesting or requiring that a person undergo a genetic test, and prohibits employers from using genetic information to make employment decisions.
Dec. 12, 2007 - The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction. For further information, read the FDA announcement.
