Hiltzik: Who will own the genetic information held by 23andMe? - Los Angeles Times
▻https://www.latimes.com/business/story/2025-03-26/23andme-files-for-bankruptcy-putting-its-hoard-of-personal-health-informati
So let’s take a look at the saga.
At first the company’s product was focused on giving customers information about their ancestry. Stories abounded about users’ discoveries of heretofore unknown ethnic backgrounds or even discovering unknown relatives.
It was promoted by Oprah Winfrey, and its retail DNA test was ranked first among the “Best Inventions of 2008” by Time, which named Warren Buffett, Rupert Murdoch, Ivanka Trump and Harvey Weinstein (in his pre-MeToo days) as members of its glittering customer base. Its $99 test kits became popular gifts for Christmas, Mother’s Day and Father’s Day; seasonality is still an important element of sales, the company has disclosed.
But cracks were already emerging in the company’s business plan at the time it went public. As it expanded the claims for its product from helping people suss out their ancestry to giving them information about their genetic predispositions to certain diseases, it attracted the notice of the Food and Drug Administration. In 2010, the FDA warned the company that it might be breaking the law by failing to provide evidence of “the analytical or clinical validity of its tests” to the agency for its approval.
The agency followed up in November 2013, ordering the firm to “immediately discontinue marketing” its test kit until it got FDA approval. The agency was especially concerned about a TV commercial 23andMe had been running, implying that its tests could help alert customers to their predispositions to heart disease, arthritis, gallstones and many other conditions; the agency also groused that the company had not been entirely cooperative with its regulatory review.
The company acknowledged that “we have not met the FDA’s expectations regarding timeline and communication.” Wojcicki, then the CEO, said in a blog post that 23andMe would cease offering customers “health-related” analyses until it could get right with the FDA. The agency finally approved the company’s marketing of tests to determine genetic dispositions to 10 health conditions, including Parkinson’s, Alzheimer’s and certain blood clotting disorders, in 2017.
But even then the FDA warned that “genetic risk” could be overinterpreted by lay consumers — it’s “just one piece of the bigger puzzle,” the agency said; “it does not mean they will or won’t ultimately develop a disease.”
That issue was raised by medical experts from the very beginning. “We are notoriously poor at estimating risk and communicating relative and absolute risk,” Harvard epidemiologist David Hunter told me in 2013 for my first report on 23andMe.
That’s especially true in genetics, where the effect of a single gene or mutation can be vanishingly incremental, especially when measured against environmental or behavioral factors, but the revelation that you carry it can sound like the tolling of a bell.
In certain respects the trajectory of 23andMe resembles that of another venture investor darling in the healthcare space, Theranos. The latter company collapsed among evidence of fraud in its marketing of a medical device that was pitched as a way to allow people to take charge of their own healthcare decisions. (Its founder, Elizabeth Holmes, is currently serving a nine-year prison sentence.)
To be clear, 23andMe has never been the target of fraud allegations; the products it has been selling are real enough, unlike those of Theranos. But questions about the efficacy and usefulness of its consumer products have followed it almost from the start. There was always buzz surrounding 23andMe during its heyday. The question is: Was there ever anything more than buzz?
