In a harshly worded letter released Monday, the Food and Drug Administration (FDA) ordered the company 23andMe to “immediately discontinue marketing” its saliva spit test (from which a consumer’s DNA is isolated) and personalized genome service until it provides the FDA with requested information on safety and effectiveness. I asked Reed Pyeritz, MD, PhD, a medical geneticist at Penn and former president of the American College of Medical Genetics, to comment on this development. He wrote:
Last week’s article by Jon Skinner in the MIT Technology Review, The Costly Paradox of Health-Care Technology was an excellent synopsis of the unique and bizarre relationship between technology and the marketplace that exists in American medicine. Unlike almost any other sector of the economy, in health care new technology drives up costs while often providing little or no benefit.
This Issue Brief summarizes a series of studies examining the uncertainties revolving around chromosomal microarray testing, which has become the new standard of practice in genetic testing of children with unexplained anomalies.
This Issue Brief summarizes the problem, describes ongoing governmental efforts to influence the process, and suggests changes in regulatory science and translational medicine that may promote more successful development of safe and effective therapeutics.