According to an SEC filing, mail-order personal genome service and research company 23andMe has raised $79 million, in a round the company hopes will top out at $150 million. The investors are undisclosed and 23andMe declined to comment while the round was ongoing.
This is the company's largest single funding raise to date. It brings its total funding to $190 million plus a $1.4 million research grant from the National Institutes of Health. Past investors include Google Ventures, Johnson & Johnson, MPM Capital, New Enterprise Associates, Sergey Brin and Esther Dyson.
23andMe's business model has endured some twists and turns over the last few years after the FDA made the company halt sales of its disease diagnostic product in the United States. Prior to the FDA's action, the company offered a mail order gene test that sequenced part of a person's genome for as low as $99. Participants could elect to make their data available for research purposes, but the main deliverable was a continuously update dashboard that included basic risk levels for a number of diseases and predictions for various genetically-linked traits.
In a public letter in November 2013, the FDA made it clear that they would require clearance for each of the myriad genetic tests 23andMe performed on each partially sequenced genome, which created a serious impediment to 23andMe's approach.
The company stopped selling the home testing kits, save a version that would return ancestry information only. After that, 23andMe began selling the service in the UK, while declaring its intention to comply with FDA regulations stateside. They submitted a clearance request for their DNA test for Bloom Syndrome. That test was finally approved in February as a de novo clearance, meaning the FDA didn't consider any predicate device to exist. The company is now waiting for clearances for additional tests before it resumes offering its disease testing product again, they said in a February statement.
"This is a major milestone for our company and for consumers who want direct access to genetic testing,” Anne Wojcicki, 23andMe CEO and cofounder said at the time. “We have more work to do, but we remain committed to pursuing a regulatory path for additional tests and bringing the health reports back to the US market. This important first step would not have been possible without the hard work and guidance of the FDA.”
In the meantime, 23andMe has been reinventing itself as a research company. In March, the company created a therapeutics group led by former Genentech executive Richard Scheller. The group will use 23andMe's database of consented, re-contactable subjects with sequenced genomes to develop new drugs. In May, the group announced its first major partnership, a 5,000-subject collaboration with Pfizer to study lupus. In June the company genotyped its one millionth customer.
"23andMe’s one million customers are pioneers in the age of personal genetics,” Wojcicki said at the time. “Our customers have changed the way we view ownership of personal health information, and enabled us to create a new, faster way of conducting genetic research.”