23andMe, the Mountain View genetics testing company, has received approval from the Food and Drug Administration to sell tests that indicate people’s risk of developing 10 diseases including Parkinson’s, Alzheimer’s, celiac and some blood clotting disorders.
The approval, announced by the company Thursday, marks a partial reversal by the FDA. In 2013, the agency ordered 23andMe to suspend the sale of its flagship product, which analyzed customers’ genes and assessed their predisposition for developing hundreds of diseases.
23andMe,a privately held firm founded in 2006, is the first company to receive authorization from federal regulators to sell, directly to consumers, tests showing personal risk for certain diseases.
“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” 23andMe co-founder and CEO Anne Wojcicki said in a statement. “It is a significant step forward for 23andMe and for the adoption of personal genetics.”
23andMe tests for genetic health risks and ancestry by analyzing a saliva sample. The company has more than 2 million customers, according to a spokeswoman.
The company is considered a Silicon Valley darling in the field of genetic testing, having received $126 million from Google Ventures and other prominent investors. Wojcicki was previously married to Google co-founder Sergey Brin.
In 2013, when the FDA issued a warning letter to 23andMe, regulators said they were concerned the company had not provided data to show its tests were accurate, and that people might use the information to make health decisions, such as seeking surgery after discovering they carried the BRCA gene mutation, which increases a woman’s risk for breast cancer. After this, the company suspended genetic health reports but continued selling ancestry reports. It resumed the sale of some genetic health reports in 2015, but in a more limited way. It never resumed the BRCA test.
“What’s different now is 23andMe has provided sufficient data to show the tests are accurate,” FDA spokeswoman Tara Goodin said Thursday.
The company also faces a 2013 lawsuit that claims it misled consumers by advertising its test kits without providing clinical data that they are accurate and safe. The company declined to comment on the pending litigation but said the newly approved genetic health reports “meet the FDA’s pre-market requirements to demonstrate analytical accuracy, clinical validity and user comprehension.”
Catherine Ho is a San Francisco Chronicle staff writer. Email: cho@sfchronicle.com Twitter: Cat__Ho
