Direct-to-Consumer Genomics Reinvents Itself

By putting its foot in the door at the FDA, can 23andMe reinvigorate direct-to-consumer genomics? Malorye Allison investigates.

In July, 23andMe filed for US Food and Drug Administration (FDA) clearance for 7 of its 200-plus genetics tests, the first 510(k) submissions from a direct-to-consumer (DTC) genetics business. The filing is considered de novo because there is no preexisting standard (“predicate device”), the usual benchmark used by the FDA to evaluate devices for premarket approval. Although individual tests cover some of the same genes, nothing on this scale has a 510(k) approval.

The filings were a surprise to many. In 2010, the FDA made it clear through a set of letters to the industry that it felt such tests needed regulation, yet the agency has done little publicly to clarify what the approval pathway might look like. Furthermore, the value of the information to consumers in these tests remains somewhat controversial. The American College of Obstetricians and Gynecologists, for one, believes that “there remains a paucity of evidence that more than a few of these SNPs [single-nucleotide polymorphisms], either alone or...