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New Consumer Genomic Services Raise Questions About FDA Regulation

NEW YORK (GenomeWeb News) — The recent debut of consumer genomics services from Decode Genetics and 23andMe have raised questions about whether the US Food and Drug Administration will get involved in regulating the services, and if so, to what extent.
An FDA official said this week that while the agency is following these new services with interest, it cannot comment further at this time.
Officials from Decode, whose service debuted Nov. 16, and 23andMe, which launched its service three days later, stressed that they are not offering consumers genetic tests — such as those offered to consumers by DNA Direct.
“We can’t really speak to how the FDA is going to respond, but what we can tell you is that we feel very strongly that we also … are very aligned with the FDA and that we want to do things that are for the good of society and for the benefit of genetic research,” said Linda Avey, co-founder of 23andMe.
She added that the firm would remain close to “all of the stakeholders in this area” to try and ensure it is “aligned with all of the objectives and the principles of these bodies.”
Likewise, the DecodeMe website tells potential subscribers that the service is not offering genetic tests.
“We strongly encourage you not to use this to make medical decisions,” Decode CEO Kari Stefansson said during a recent webcast. “If there is something that raises concerns when you look at your result … you can ask a question that will be answered by our experts.”
The firm may also refer subscribers to a genetic counselor.
However, genetic testing, and direct-to-consumer genetic testing in particular, has come under increased scrutiny over the past year and a half. Last year, the FDA, the US Federal Trade Commission, and the US Centers for Disease Control and Prevention issued a joint statement warning consumers of some of the pitfalls of at-home genetic testing — including DTC pharmacogenomic testing.
Although the statement acknowledged that DTC companies’ pharmacogenomic claims are based on trustworthy science, it warned consumers not to act on that information alone. At-home tests that can give information about a person’s response to certain drugs “are not a substitute for a physician’s judgment and clinical experience,” the agencies said.
“At some point regulatory oversight makes some sense because you need to justify to at least somebody that what you’re looking at really does what you say it does,” Harry Glorikian, managing partner of life science consulting firm Scientia Advisors, told GenomeWeb Daily News sister publication BioCommerce Week this week.
“I don’t know when somebody over there [at FDA] says, ‘OK, you’ve crossed that fine line,’ whatever that fine line is, because it is still being defined,” he added. However, “they do not want to come out and quash this out of the gate.”

A comprehensive version of this article appears in this week’s issue of BioCommerce Week, a GenomeWeb Daily News sister publication.

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