Michael GirdleyGirdley Enterprises, Girdley Enterprises, Inc. · Business builder and investor

23andMe fought the FDA, then collapsed anyway

Name: 23andMe fought the FDA, then collapsed anyway
Uploaded: 2026-04-27T14:26:23+00:00
Duration: 2 min 2 s
Channel: Michael Girdley
Description: The video recounts the rise and fall of consumer DNA testing company 23andMe. In 2013 the FDA ordered the company to stop selling its health‑risk DNA…

27 Apr 2026 · 2 min

Watch on YouTube

2:02

The video recounts the rise and fall of consumer DNA testing company 23andMe. In 2013 the FDA ordered the company to stop selling its health‑risk DNA test, demanding clinical data and proper approvals. Founder Anne Wojcicki spent the next five years submitting over 7,000 pages of documentation and conducting clinical studies, eventually winning FDA clearance and returning the product to market. In the early 2020s 23andMe went public via a SPAC backed by Richard Branson, achieving a valuation above $6 billion. GlaxoSmithKline invested $300 million, hoping to use the company’s genetic database for drug discovery, but the drug‑discovery pipeline never materialised. The core business model was weak – customers paid once for a test and rarely returned – and the company’s data was later breached, exposing the private information of more than 7 million users. The breach triggered a massive loss of confidence, the stock fell more than 98%, the company was delisted and declared bankruptcy. Despite the collapse, Anne Wojcicki repurchased control of the company for $300 million. The video points viewers to a longer‑form video for a deeper dive.

Chapters

Tech startup 23andMe was selling DNA tests to millions of people and offering them information on everything from who their relatives were to health risks. But suddenly the FDA called and said, "You can't sell this anymore. You haven't gone through all the proper approvals." Well, here's what happened next. In 2013, the FDA said they were fed up. They had been asking 23andMe for clinical data and information around the DNA test they were offering to consumers. You know, you spit in a tube and send it off, uh, and said they couldn't take it anymore and they wanted this product off the market. 23andMe had been selling this test for originally $999 and then $99, and suddenly they couldn't sell it anymore. Lawsuits piled up and revenue went through the floor. Many entrepreneurs faced with something like this, which was going to be a multi-year battle fighting the government, would just give up. Heh, heck, I would. Life's too short. But she spent the next 5 years going back and forth, fighting tooth and nail with the FDA to get her product back on the market. She submitted over 7,000 pages of documents, ran clinical studies, and eventually grinded it out and got back into the market. Years later, the FDA would entirely reverse course and allow them back onto the market. In the early 2020s, the company would go public via a SPAC backed by Richard Branson and eventually get valued over $6 billion. Famous drug maker GlaxoSmithKline would invest $300 million and use the information they were gathering to help build new drugs. But it turned out the entire business had really been built on a shaky foundation. In fact, they didn't have much of a business model at all. The drug discovery stuff would prove not to work, and the DNA test, well, you'd pay for it once and never come back. And eventually their database got hacked, over 7 million people's private information was released, and the stock went down over 98%, eventually getting delisted and declaring bankruptcy. And the story of what happens next is a complex one, because Anne, the founder and CEO who'd done all that fighting, managed to regain control of her company. It just took her $300 million to do that. If you're interested in the full story and fleshing out more of what happened to 23andMe, there's a link to the long-form video I did below.