Pharmaceutical International News - July 2012
FDA DNA Testing Kit Approval Sought
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 31/07/2012 - 06:40:00
Genetic test kit manufacturer 23andMe is seeking US FDA approval for its personalised DNA testing kit. If such approval is forthcoming, its product and others of the same kind could become more widely accepted since, at the moment, a number of scientists aren't convinced that they're particularly useful.
23andMe's DNA tester gives ordinary members of the public the tools to view their particular genetic make-up. The data can be used to assess past family information or - controversially - to get some insight into whether future diseases or conditions are likely to develop, including the likes of Alzheimer's and breast cancer.
In seeking the FDA's approval, 23andMe is also, therefore, hoping that its kit gets accepted by the scientific community.
FDA DNA Kit Approval
"It's the next step for us to work with the FDA and actually say, `this is clinically relevant information and consumers should work with their physicians on what to do with it'", 23andMe's co-founder, Anne Wojcicki, stated in comments on the FDA DNA kit approval submission quoted by Fox News.
According to data released by the company on 30 July 2012, seven of its kits are now with the US Food and Drug Administration for review purposes. It's planned for an additional 100 to be submitted by the end of 2012 but excluded will be tests that cover inherited traits and non-medical data, since they're outside the administration's scope of coverage.
DNA Testing Kit
"FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care", Wojcicki said in a company press release on the DNA testing kit approval submission.
She continued: "As the knowledge around personalized medicine continues to grow, consumers should expect their healthcare providers to begin to incorporate genetic information into their treatments and preventative care. We believe our ongoing conversations with the FDA and ultimately securing clearance will be very important as we continue to serve our customers with genetic information that is an essential consideration in their personal health, and continue to grow our community, which is now more than 150,000 strong,"
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