23andMe analyses DNA in saliva provided by customers to product genealogy information and health-risk predictions.Credit: Tiffany Hagler-Geard/Bloomberg via Getty
The once-thriving consumer genetic-testing company 23andMe is struggling to stay afloat — raising concerns about what might happen to its customers’ data and the broader industry.
The decline marks a fall from grace for a pioneering company once valued at US$6 billion. Over the past few years, the firm has faced mounting challenges, including financial losses and a huge data breach, although this did not involve DNA data. In September, most of the company’s board resigned, and in November the firm said it would cut 40% of its workforce and halt its therapeutics division, which had drugs in clinical trials.
Founded in 2006, 23andMe built its business by asking paying customers to send samples of saliva, from which they extract and sequence DNA to analyse for information about ancestry, family traits and potential health risks. Some 15 million people have sold their DNA to the company, based in Sunnyvale, California. Of those, around 80% consented to have their genetic information used for research.
The rise and fall and rise again of 23andMe
What led to 23andMe’s downfall? What might the company’s struggles mean for consumer genetic testing and research? Nature spoke to specialists to find out.
DNA testing kits are a one-time product
One key issue is that DNA-testing companies are selling a single-use product. “Once somebody has done it, they don’t need to do it again,” says Hank Greely, a lawyer and bioethicist at Stanford University in California.
Starting in around 2016, sales of direct-to-consumer genetic tests soared, with 23andMe and Ancestry in Lehi, Utah, securing the lion’s share of customers worldwide. But by 2020, sales had declined, and both firms began cutting staff.
People flocked to these products for the genealogical information they provided: a breakdown of the potential geographic origins of your ancestors. Companies, including 23andMe, also offered customers the opportunity to connect with relatives worldwide. “The market for genealogical information is large, but it’s not infinite,” Greely says. “Some of the companies will try to upsell you with the newest, fanciest version, but the fanciest version can tell you whether this person is probably a third cousin or a fourth cousin. Who cares?”
Health-risk predictions posed problems
In a bid to add to their offerings, companies such as Ancestry began selling access to historical records and photographs to give people extra genealogical information. One of 23andMe’s main offerings has been health information — but this has drawn criticism.
Experts have long raised concerns about providing consumers with predictions of disease risk based on consumer tests. In its early days, 23andMe offered a test with information on the risk of 240 health conditions. But in 2013, the US Food and Drug Administration (FDA) ordered it to stop, citing a lack of information on the safety and efficacy of the assessments. In 2017, the company received FDA approval to tell customers if they had genetic mutations linked to ten conditions, including Parkinson’s and coeliac disease. Since then, 23andMe has expanded this to more than 50 conditions.
Ancient DNA reveals the living descendants of enslaved people through 23andMe
But despite such consumer tests winning FDA approval, clinicians have continued to question their reliability and utility. False negatives might reassure a person that they don’t have a disease-causing mutation that they actually have, and false positives might lead people to seek preventive interventions, such as surgery to reduce cancer risk, that they don’t need.
A spokesperson for 23andMe says that the company has “demonstrated over 99% accuracy and reproducibility for the variants we test for in our genetic health reports” and that it has worked closely with regulators to ensure that the company provides accurate and meaningful genetic information to consumers. The spokesperson also says that 23andMe’s products do have clinical utility, adding that its health reports help to identify at-risk individuals and motivate healthy lifestyle choices, among other things.
Anneke Lucassen, a clinical geneticist at the University of Oxford, UK, remains sceptical about 23andMe’s tests. “Their product was always very limited in what it could tell you about tendencies to disease,” she says, in part because common diseases are the product of more risk factors than can be measured by 23andMe.
Some are pessimistic about the overall future of consumer DNA tests for health care. “The medical side never really caught on,” Greely says. “And to the extent it would catch on, it should be moving into regular medicine.”
Genetic data present privacy concerns
If 23andMe folds, the fate of its customers’ genetic information is a major worry. Concerns include the possibility of sensitive health-related information, such as disease risk, being revealed, or law-enforcement bodies searching DNA databases for suspects — although the company has stated that it does not allow such investigations.
In the United States, customers of genetic-testing companies aren’t protected under laws such as the Health Insurance Portability and Accountability Act, because these firms lie outside health care, for which there are strict controls over genetic data.
Anne Wojcicki, 23andMe’s chief executive, has said that the company is not open to takeover.Credit: Jordan Vonderhaar/Bloomberg via Getty
