Recently published in the May issue of Clinical Chemistry, Linnea Baudhuin, Ph.D., of the Mayo Clinic Center for Individualized Medicine, assessed 23andMe, one of the largest direct-to-consumer genetic testing facilities, and its Personal Genome Service test.
One of her main critiques is that it is not a comprehensive genetic analysis, a limitation about which many consumers are not aware. Though many medical conditions might be associated with a long list of pathogenic mutations, sometimes numbering in the thousands, the Personal Genome Service test only detects a small percentage of these.
Dr. Baudhuin surmises that the FDA was left with no choice but to require that if 23andME wanted to sell a health-related medical device to consumers, it needed to demonstrate that the product is safe and effective, or cease offering the test.
Read the full article here.