This article has been updated to clarify details of FDA's letter.
NEW YORK (GenomeWeb) – The US Food and Drug Administration has sent a letter to Sure Genomics asking why the company is marketing its SureDNA sequencing test, which collects and analyzes saliva samples and reports disease risk and drug response information to patients, without its clearance.
"We have conducted a review of our files, and have been unable to identify any FDA clearance number for the SureDNA test," the agency wrote in a Feb. 16 letter to Sure Genomics CEO Warren Little. "We request that you provide us with the FDA clearance number for the SureDNA test. If you do not believe that you are required to obtain FDA clearance for the SureDNA test, please provide us with the basis of that determination."
The FDA is intending to finalize guidelines on the regulation of laboratory-developed tests (LDTs) later this year. The agency believes LDTs — tests developed and performed at a single lab which have been traditionally regulated under CLIA — classify as devices that should be regulated under its aegis.
In its letter to Sure Genomics, the agency stated that the SureDNA kit appears to meet the definition of a device under the Federal Food Drug & Cosmetic Act.
Sure Genomics collects customers' saliva for genomic analysis using the SureDNA kit. Earlier this month, the company launched a full DNA sequencing service that customers can order directly from the company in order to learn their whole-genomic sequence. Additionally, the company said it would provide "initial reports made available with physician oversight" on whether consumers have mutations in the BRCA1 and BRCA2 genes, which are associated with heightened risk of breast and ovarian cancer, as well as genetic markers associated with drug response, drug interactions, fitness, nutrition, traits, and ancestry.
"Sure Genomics will release additional reports after they meet all required FDA regulatory standards," the firm stated at the time it launched this service.
Last year, before launching this service, Rick White, Sure Genomics' founder, told GenomeWeb that the company planned to be "fully compliant" with the FDA, which meant that at first it probably wouldn't be able to launch reports on genetic markers associated with disease risk and would focus on introducing products the FDA wouldn't consider high risk, such as reports on wellness traits.
The company seems to have moved away from this strategy. The company did not provide a statement on the FDA letter before press time and has not been able to provide an interview despite multiple requests from GenomeWeb since the firm launched its testing service.
Meanwhile, in an interview with GenomeWeb in January, Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Device Evaluation in FDA's Center for Devices and Radiological Health, noted that the agency is looking into direct-to-consumer testing services that rely on ordering of the test "either by the physician that is incorporated into the company or [who] somehow has a relationship not with the patient but with the company."
According to a video posted on Sure Genomics' site, "All sequences are directed by a physician and produced in CLIA-certified labs." The reports from the company can be shared with the customer's own healthcare provider or family member if he or she wants, according to the video.
A number of consumer-facing genetic testing companies have adopted a similar model. Last year, the agency sent a letter to Pathway Genomics, expressing concerns about a new liquid biopsy cancer test it was marketing through a "direct-to-consumer type model" to asymptomatic people without premarket approval or clearance.