Sure Genomics has launched its $2,500 direct-to-consumer genome sequencing service, the company has announced. The service, for which customers will have to obtain a prescription, includes full DNA sequencing at a CLIA-certified lab, HIPAA-compliant data storage, re-analysis of the DNA sequence data every six months, and ongoing reports, according to the company. Beyond the first year, the company will store and re-analyze their customers' genomes for a $150 annual fee.
As GenomeWeb has reported, the company plans to be "fully compliant" with the US Food and Drug Administration. As such, Monica Heger writes that it may not return data on disease risk at its launch, though co-founder Rick White has said that is the company's eventual goal.
Indeed, in its press release, the company says that its initial reports will include information on BRCA1 and BRCA2 gene mutations, drug response and interaction, fitness and nutrition as well as on traits and ancestry.
"We have been in contact with the FDA and we feel like we've built a system and process that would meet their requirements," White tells the Verge. "[Our] reports are going to be delivered in, I would say, an ultra-compliant manner."
However, White also says that the company hasn't sought FDA approval for its health reports and that agency officials haven't seen its final platform, the Verge adds.
In 2013, consumer genomics company 23andMe ran into issues with the FDA regarding its Personal Genome Service, and the company had to stop marketing its tests. The company began offering health reports again in 2015 on a limited basis. It now offers its customers results on a smattering of traits, including an FDA-approved carrier status report for conditions like Tay-Sachs, cystic fibrosis, and sickle cell anemia, for $199.
As the Verge notes, 23andMe hasn't received clearance for returning disease risk estimates directly to consumers. "That's why Sure Genomics' assertions that its health risk and drug response reports will be just fine with the FDA are so puzzling," it adds.