Personal genetics company 23andMe has received a nearly $1.4 million grant from the National Institutes of Health (NIH) to help expand the company’s genotype database and aid in its efforts to discover gene variants linked to specific diseases.
"This grant from the NIH recognizes the ability of 23andMe to create a unique, web-based platform that engages consumers and enables researchers from around the world to make genetic discoveries," said 23andMe’s cofounder and CEO Anne Wojcicki in a statement.
Under the terms of the two-year grant, 23andMe must publish its discoveries in peer-reviewed scientific journals.
News of 23andMe’s grant from the NIH is somewhat surprising given the FDA’s crackdown on the company’s services. Last November, the FDA sent 23andMe a threatening warning letter demanding the company stop offering its customers health reports that detail the likelihood of them getting any number of diseases. The FDA ruled that the $99 saliva-test kit from which the health results are drawn qualifies as a medical device, and therefore requires FDA approval before it can be sold to consumers. 23andMe complied with the FDA’s demands by limiting its services to offering ancestry information and genetic data—but there seems to be recent progress of getting back in the FDA’s good graces.
In June, the FDA accepted for review one health report from 23andMe for targeting Bloom syndrome, an inherited disorder associated with an increased cancer risk and short stature. 23andMe said in a blog post, "While we are still in the very early stages of this regulatory review process, we remain committed to transparency and keeping our customers as informed as possible. This by no means is the end of the process even for this one condition."
As tentative as its status is with the FDA, 23andMe’s grant from NIH will certainly be helpful in eventually building out the service most customers seemed to care about most: personalized health reports.