23andMe can now sell a genetic test for breast cancer to anyone who wants one
The genetic testing company 23andMe has gotten permission from the US Food and Drug Administration to sell a test directly to customers that detects DNA mutations associated with a higher risk of several cancers.
What it does: The test, which will be available through 23andMe’s $199 health and ancestry service, reports three genetic variants of the BRCA1 and BRCA2 genes that are most common in people of Ashkenazi Jewish descent. Mutations in these genes raise a person’s risk for breast, ovarian, and prostate cancer.
Limited test: There are more than 1,000 known mutations found on BRCA genes, and 23andMe’s test doesn’t yet look at the most common ones in the general population. The FDA cautions that a negative result from the test doesn’t rule out other BRCA mutations or an increased risk of cancer.
Why it matters: In 2013, the FDA ordered 23andMe to stop marketing a health test for 250 diseases, including BRCA-related cancers, citing the potential for the results to confuse customers and possibly lead to unnecessary tests or surgery. Last year, the FDA finally gave its approval for 23andMe to market a more limited test, the first direct-to-consumer genetic test for health risks.
Deep Dive
Biotechnology and health
What to know about this autumn’s covid vaccines
New variants will pose a challenge, but early signs suggest the shots will still boost antibody responses.
A biotech company says it put dopamine-making cells into people’s brains
The experiment to treat Parkinson’s is a critical early test of stem cells’ potential to tackle serious disease.
Tiny faux organs could crack the mystery of menstruation
Researchers are using organoids to unlock one of the human body’s most mysterious—and miraculous—processes.
How AI can help us understand how cells work—and help cure diseases
A virtual cell modeling system, powered by AI, will lead to breakthroughs in our understanding of diseases, argue the cofounders of the Chan Zuckerberg Initiative.
Stay connected
Get the latest updates from
MIT Technology Review
Discover special offers, top stories, upcoming events, and more.