FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases

April 7, 2017
By Alex Keown, BioSpace.com Breaking News Staff

MOUNTAIN VIEW, Calif. – DNA-testing company 23andMe got a boost Thursday afternoon when the U.S. Food and Drug Administration granted the company the first authorization to market genetic reports on personal risk for certain diseases.

The new authorization allows consumers to acquire the company’s $199 DNA kit to test themselves for a handful of diseases including late-onset Alzheimer's disease, Parkinson's disease, celiac disease and hereditary thrombophilia, all without having to go through a physician.

Anne Wojcicki, 23andMe chief executive officer and co-founder, called the authorization an important moment for people who want to know more about their genetic health risks in order to take a more proactive stance.

"The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics,” Wojcicki said in a statement.

In an interview with CNBC, Wojcicki said the top test that customers are seeking is to determine if they have a genetic predisposition to Alzheimer’s disease.

This is the second time the company has offered such testing. In 2013, the FDA sent a warning letter to the California-based company, saying it must discontinue marketing its health-related genetic tests. The company was forced to stop selling the kits for medical or diagnostic uses, although they could continue to sell them without offering clinical diagnostics. Eventually though, the company began to resell health data. The U.S. Food and Drug Administration (FDA) approved 23andMe’s Personal Genome Service that provides carrier status, wellness, trait and ancestry reports to consumers in October 2015.

The FDA approval for genetic health risk reports were evaluated through the de novo classification pathway, a regulatory process for low- to-moderate-risk medical devices, the company said. In its approval, the FDA indicated it will create a class II exemption for 23andMe's substantially equivalent reports, opening a pathway for the company to release additional genetic health risk reports, 23andMe said in its announcement.

With the authorization, 23andMe said it will offer its first set of new genetic health risk reports this month. The reports will include tests for Late-Onset Alzheimer's Disease, Parkinson's Disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency, and a new carrier status report for Gaucher's Disease. Additional reports are expected to follow. The company is still not cleared to offer testing for breast cancer, CNBC said.

In October, 23andMe has halted its plans to develop a new gene-sequencing program that would have allowed customers to learn more about potential predisposition to genetic diseases. Wojcicki said the problem was the data was so complex that it might not do the consumer any good. Because the company has a direct-to-consumer product as opposed to direct-to-physician, Wojcick said the gene-sequencing project just would not fit that model.

23andMe could see a boost in fundraising following the FDA approval. The company has raised more than $240 million in venture funds from Alphabet (formerly Google , the National Institutes of Health and others, CNBC said.