While Google ($GOOG)-backed personal genetics startup 23andMe is still working through its disagreements with the FDA, the company has impressed another part of the federal machine enough to win funding. And having snagged the $1.4 million National Institutes of Health grant, 23andMe plans to open up its trove of genotype and phenotype data to partners in industry and academia.
The initiative will see 23andMe give a "limited" number of partners access to de-identified genotype and phenotype data from 400,000 people who agreed to participate in its research program. Aggregating information gathered from these people is expected to yield a database of 40 million single nucleotide polymorphisms (SNP), a resource 23andMe thinks can help researchers associate genes with conditions. NIH has first-hand experience of using 23andMe data for research, with the agency working with the startup on a paper on Parkinson's published in Nature Genetics this week.
Granting more third parties access to the data could lead to similar advances in understanding of other genetic disorders. The other projects enabled by the NIH grant try to make such advances possible by strengthening 23andMe's data. 23andMe will use the cash to refine the surveys it asks customers to complete--and create 15 new questionnaires--to gather phenotypic data and link genetic variants to health conditions. The final pillar of the NIH-funded work will see 23andMe use whole-genome sequence data to find rare variants.
While the grant helps to strengthen and validate 23andMe's research business, observers have warned against inferring anything about the startup's relationship with FDA. "It is a common everyday occurrence that one federal agency might invest in a new technology that another federal agency views with skepticism. So the NIH investment means nothing with regard to FDA," Epstein Becker Green attorney Brad Thompson told VentureBeat.
But while the NIH grant may offer little insight into the FDA's intentions, Thompson said the warning letter does. "I think FDA loves the technology. If you read the FDA warning letter, the agency clearly invested a tremendous amount of time working with the company trying to guide them through the FDA process. That is extremely rare for FDA to invest that much time in one company," Thompson said.