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23andMe Requests FDA Clearance for DNA Saliva Testing

Posted Aug 02 2012 12:00am

23andMe has been at a transition point in its business model, trying to decide whether to continue as a "personal" genetic testing site or become a full-fledged medical and regulated DNA testing service. I covered this issue in a prior post (see: 23andMe Acquires Curetogether; Pursues "People-Powered" Research ). Here's a quote from it:

The strategic direction of 23andMe has always been of interest to me (see:  Web-Based Genomic Testing Sites Fail to Attract Large Paying AudienceClinical Labs Have Much to Learn from the Genetic Testing Web Sites ). On one hand, the company is positioning itself as a personal genomics web site to avoid the regulatory pressure associated with rendering medical diagnoses. On the other hand, it has also been involved in projects of significant medical interest (see:  23andMe Builds Online Sarcoma Research Community ). The question remains whether it can continue to straddle this fine line and evolve in both directions.

It appears now that the company is moving in the direction of full-fledged DNA testing web site which will be more complicated but result in greater functionality and probably more profits (see: Google-Backed 23andMe Asks FDA To Clear DNA Evaluation Service ). Below are the details from a current article citing a new development:

23andMe , the Google-backed DNA analysis company ...sought U.S. regulatory approval for a genetic testing service that may help people assess their risk for developing cancer and Alzheimer’s. The submission with the Food and Drug Administration will cover seven tests, which 23andMe isn’t specifying....The tests are part of a service that tells users whether they carry a disease, are at risk of a disease and would respond to a drug....The FDA decided in 2010 that services claiming to evaluate a customer’s risk of disease must be cleared by regulators if the companies sell directly to consumers.“23andMe [according to a spokesperson[ is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust,”....Such types of genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which work best....23andMe said it submitted the FDA application today for the least stringent of two types of medical device reviews. The company plans to submit “several” more applications by the end of this year.... DNA Genotek ..., a company bought last year by OraSure Technologies, makes the FDA-approved saliva kit. ...23andMe is seeking approval of the process for analyzing and interpreting DNA results for patients....Most FDA-cleared genetic tests are for a single disease while 23andMe’s would be the first to test for multiple conditions....

Here a cut-and-paste from the DNA Genotek web site:

DNA Genotek, a subsidiary of OraSure Technologies, Inc., develops products that optimize ease of collection and provide superior samples and proven performance for those requiring high-quality biological samples for nucleic acid testing. High-quality samples that are easily collected from target populations enable our customers to focus on translating their analysis and testing into significant worldwide advancements in health and science.

All of this makes sense. Saliva collection is a non-interventional way to obtain DNA from the sloughed mucosal cells. After DNA extraction from the cells, the major challenge is that of predictive medicine, which is to say figuring out which SNPs provide predictive clues about the seven diseases noted in the press release (see: SNP Fact Sheet ). This approach is a "roll of the dice" for both 23andMe as well as their chosen DNA testing company, DNA Genotek. If the latter's technology proves to be superior, the partnership should prove to be formidable. The deal combines 23andMe with its web-empowered customer base and DNA Genoteck with its science and technology. Here's a similar take on this same idea (see:  Gene-testing firm 23andMe seeks groundbreaking FDA approval ):

[23andMe] already legally sells the tests, which cost $299 per person. But it is believed to be the first direct-to-consumer genetic testing firm to seek U.S. Food and Drug Administration certification of its products. If the FDA gives that stamp of approval, industry observers say, it not only would give the company a leg up on its competitors but bring much-needed government supervision to the business.

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