SNP chips, a type of DNA microarray frequently employed by consumer genomics companies, are "extremely unreliable" when identifying clinically-relevant variants that are rare among the general population, according to a retrospective study recently published in The BMJ.
The investigation, conducted by researchers from the University of Exeter, reviewed sequencing data from nearly 50,000...
FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the...
