The FDA’s 23andMe decision will also change the rules for all at-home medical genetic testing
By Dave Gershgorn,
Quartz
| 04. 10. 2017
Doctors are losing their role as the gatekeeper of our health information, for better or worse.
Last week, the US Food and Drug Administration made a surprise announcement giving genetic testing company 23andMe clearance to sell a service that gives customers a risk analysis for 10 genetically linked diseases. It reverses a 2013 decision that cited concerns that inaccurate testing results—and potential customer misinterpretation—made for a public health threat, and builds on a 2015 agreement between the FDA and 23andMe that allowed the company to offer a test that told customers of their “carrier status” of genetic markers for certain diseases—but not assess their actual risk. This latest decision means 23andMe will again be able to provide specific risk analyses to customers, and perhaps more importantly, throws the door wide open to dozens of other companies to run out their own versions of at-home genetic risk-analysis products.
The disease risk that 23andMe offers isn’t a diagnosis; it just gives you your potential for elevated risk. For example, if a person inherited a copy of the ApoE4 gene variant from both...
Related Articles
By Carly Mallenbaum, Axios [cites Emily Galpern] | 03.29.2026
More Americans are turning to surrogacy to build their families, as the practice becomes more common and more publicly discussed.
Why it matters: As surrogacy becomes more visible and accessible, ethical, legal and cultural tensions become harder to ignore...
By Carly Mallenbaum, Axios [cites Surrogacy360] | 03.29.2026
Without a federal law, surrogacy in the U.S. is governed by a patchwork of state regulations/
Why it matters: Confusing, varied local rules can determine everything from whether agreements are legally binding to who is recognized as a parent at...
Cathy Tie seems to be good at starting businesses but not so dedicated to maintaining them. CGS, like many others, first heard of her thanks to Caiwei Chen and Antonio Regalado in MIT Technology Review, May 2025, as the partner (perhaps bride) of the notorious Chinese scientist He Jiankui, described in the headline as “China’s Frankenstein.” He prefers “Chinese Darwin.” She ran his Twitter account for a while, contributing such gems as:
Get in luddite, we’re going gene editing...
By Laura DeFrancesco, Nature Biotechnology | 03.17.2026
The first gene editors designed to fix genetic lesions in mutation-agnostic ways are poised to enter the clinic. Tessera Therapeutics and Alltrna, two Flagship Pioneering-funded companies, are gearing up to test novel genetic medicines in humans. Tessera received regulatory clearance...