The U.S. Food and Drug Administration has allowed the 23andme Personal Genome Service Pharmacogenetic Reports to test marketing, with special controls, as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications. By authorizing the test to detect 33 variants for multiple genes, it is empowering patients to have well-informed discussions with their healthcare providers. Pharmacogenetics is the process of understanding what, if any, role genetics plays in a patient’s reaction to drugs. The Personal Genome Service test analyzes DNA from a self-collected saliva sample, and the report describes if a person has variants in certain genes that may be associated with a patient’s ability to metabolize some medicines. (more…)
Posts Tagged ‘FDA’
Apple has introduced the Apple Watch Series 4. Fundamentally redesigned and re-engineered with a new edge-to-edge screen (30% larger) and sound (speaker is 50% louder), it purports to help users stay even more active, healthy, and connected than before. Branding itself as a medical device, the FDA-cleared Series 4 monitors heart rhythm as it takes its user’s electrocardiogram (EKG). This data can indicate whether one’s heart rhythm shows signs of atrial fibrillation or if sinus rhythms are normal. The device is also able to recognize a fall and offer Emergency SOS, which calls 911 or notifies emergency contacts.
“The Apple Watch has become an intelligent guardian for your health,” Apple COO Jeff Williams said at Wednesday’s announcement. “Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living,” said FDA Commissioner Scott Gottlieb in a statement. The Watch Series 4 is available for order on Friday, starting at $399 (for GPS) or $499 (for GPS + cellular service).
In March, Los Angeles Superior Court Judge Elihu Berle ruled that coffee sellers in the state of California must label their products with a cancer warning, due to the presence of acrylamide. Acrylamide, a chemical only linked to cancer in animals when consumed in high doses, can form in many foods during high-temperature cooking, such as frying, roasting, and baking. In coffee, acrylamide forms during the roasting of coffee beans. Under Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, California requires products to contain cancer warnings if they will expose consumers to chemicals which state health authorities have identified as cancer-causing.
However, in a comprehensive report conducted by the World Health Organization’s International Agency for Research on Cancer, current science indicates that consuming coffee poses no significant risk of cancer. Acrylamide in food forms from sugars and an amino acid that are naturally present in food. It doesn’t come from food packaging or the environment. Based on this new report, the California agency that administers Proposition 65 has proposed a regulation to exempt coffee from a Proposition 65 cancer warning — and the FDA agrees.