Direct-to-Consumer Genomics Reinvents Itself
By Malorye Allison,
Nature
| 11. 08. 2012
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...
Related Articles
By Alondra Nelson, Science | 09.11.2025
In the United States, the summer of 2025 will be remembered as artificial intelligence’s (AI’s) cruel summer—a season when the unheeded risks and dangers of AI became undeniably clear. Recent months have made visible the stakes of the unchecked use...
By Emma McDonald Kennedy
| 09.25.2025
In the leadup to the 2024 election, Donald Trump repeatedly promised to make IVF more accessible. He made the commitment central to his campaign, even referring to himself as the “father of IVF.” In his first month in office, Trump issued an executive order promising to expand IVF access. The order set a 90-day deadline for policy recommendations for “lowering costs and reducing barriers to IVF,” although it didn’t make any substantive reproductive healthcare policy changes.
The response to the...
By Johana Bhuiyan, The Guardian | 09.23.2025
In March 2021, a 25-year-old US citizen was traveling through Chicago’s Midway airport when they were stopped by US border patrol agents. Though charged with no crime, the 25-year-old was subjected to a cheek swab to collect their DNA, which...
By Julie Métraux, Mother Jones | 09.23.2025