The Dispute between the FDA and 23andMe; What's Really Going On?

Much in the news recently is the friction between the FDA and 23andMe. I have blogged about the company and its goal of providing genetic testing directly to healthcare consumers (DCT testing) (see: Clinical Labs Have Much to Learn from the Genetic Testing Web Sites; 23andMe Requests FDA Clearance for DNA Saliva Testing). I am very much in favor of this goal. I think that the NYT presented an important slant about this dispute (see: F.D.A. Orders Genetic Testing Firm to Stop Selling DNA Analysis Service). Here is an excerpt from the article: The...[FDA] seemed most concerned about a test for mutations that indicate a woman would have a very high risk of getting breast cancer. It said a false positive on such a test could lead to an unnecessary preventive mastectomy. Scott R. Diehl, director of the center for pharmacogenomics at Rutgers, welcomed the F.D.A. action. He said tests for breast cancer risk and drug side effects required guidance from doctors and genetic counselors, and “really have no place” being offered directly to consumers. But Misha Angrist, an assistant professor at the Institute for Genome Sciences and Policy at Duke, said that with DNA sequencing becoming cheaper and easier, the F.D.A. would ultimately fail in keeping people from having access to their own genetic information. “Is the only pathway for me to get access to the contents of my cells via some guy in a white coat?” he said. “F.D.A. clearly thinks the answer is yes. I f...
Source: Lab Soft News - Category: Pathologists Authors: Tags: Clinical Lab Industry News Clinical Lab Testing Direct Access Testing (DAT) Lab Processes and Procedures Lab Regulation Laboratory Industry Trends Medical Consumerism Medical Ethics Medical Research Source Type: blogs