The Genetic Link

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Article by: Shauna White

DNA Genotek Inc. Submits Filing for 510(k) Clearance

2011-03-15

DNA Genotek Inc. announced today that it has completed filing a 510(k) pre market submission to the U.S. Food and Drug Administration for its Oragene®•Dx family of products. Oragene products are recognized for enabling non-invasive and reliable collection of DNA from saliva samples and for isolating and stabilizing DNA for transport and storage. Oragene•Dx is the newest addition to the family of products and will be commercially available upon clearance by the FDA.

Ian Curry, president and CEO of DNA Genotek Inc. said “We have filed for 510(k) clearance status on our Oragene•Dx products to reinforce the proven performance, safety and efficacy we have already demonstrated with thousands of customers in more than 100 countries around the world. We feel it is imperative for labs and molecular test manufacturers worldwide to have access to the highest quality, proven, non-invasive collection methods to enable genetic testing.”

Added Curry, “We believe that the successful completion of this 510(k) clearance will facilitate broad use of Oragene•Dx in molecular diagnostics. We continue to see an expanding set of important, valuable applications for clinical diagnostics and personalized medicine. We have filed our submission and now the final decision is with the U.S. Food and Drug Administration.”

Stay tuned to The Genetic Link for updates on our 510(k) clearance process. Subscribe below to be sure to receive the latest information.

Photo credit: Alexandra Simms
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