- Pete Davidson is OK and at work following alarming Instagram post Saturday 7:26 PM
- Wisconsin Governor Scott Walker doesn’t know how to use a Venn diagram Saturday 5:38 PM
- This college student made a movie trailer to tease her boyfriend, and Twitter can’t get enough (updated) Saturday 3:13 PM
- ‘Kappa Delta Crypto’ aims to break stereotypes in five-minute Snapchat episodes Saturday 2:29 PM
- Two iPhone X customers are suing Apple over screen size Saturday 1:18 PM
- Secretary Ryan Zinke is out at the Department of the Interior Saturday 12:03 PM
- How to watch the New Orleans Bowl online for free Saturday 10:25 AM
- Prada’s racist toys pulled from shelves after social media backlash (updated) Saturday 10:22 AM
- How to watch the Camellia Bowl online for free Saturday 10:00 AM
- How to watch the Las Vegas Bowl online for free Saturday 8:30 AM
- How to watch Real Madrid vs. Rayo Vallecano online for free Saturday 7:30 AM
- ‘Runaways’ season 2 expands its universe and mysteries Saturday 7:30 AM
- How to watch the Cure Bowl online for free Saturday 7:05 AM
- How to watch Canelo Alvarez vs. Rocky Fielding for free Saturday 7:00 AM
- Politicians who inspired the internet in 2018 Saturday 6:30 AM
The FDA just approved a genetic testing kit and set a major precedent
The kits will still be marketed under FDA scrutiny.
The FDA will allow the company to sell a kit that tests people for Bloom Syndrome, a rare genetic disorder resulting in shorter height and a higher likelihood of developing cancer. The decision comes two years after the FDA ordered 23andMe to stop selling its tests because they had failed to gain regulatory approval.
“This is also the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives 23andMe a regulatory framework for future submissions,” 23andMe CEO Anne Wojcicki wrote in a blog post, explaining that the decision paved the way for the company to begin selling other genetic testing kits.
The FDA ruling is notable because it establishes exactly how at-home genetic testing kits are defined by government regulators. Based on this ruling, the Bloom Syndrome kit is classified as a class II medical product, making it subject to special advertising restrictions but allowing it to be sold directly to consumers.
In another win for 23andMe, updated versions of Class II products like this kit do not require FDA pre-review before going to market.
Alberto Gutierrez, the FDA’s director of vitro diagnostics and radiological health, said in a statement that his agency “believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information.”
Not only is 23andMe allowed to resume selling its tests, but the FDA ruling could also help the company prevail in several ongoing class action lawsuits. Several consumers have sued 23andMe for false advertising, claiming that their marketing materials failed to disclose their products’ lack of FDA approval.
Despite this nod of approval from federal regulators, 23andMe still faces criticism from privacy advocates who worry about the fact that the company stores the genetic data of its users.
Tim Sampson is a reporter who focused on the technology, business, and politics beats. He's also an established comedy writer, with work on Comedy Central and in The Onion and ClickHole.