DNA Genotek Submits Filing for 510(k) Clearance
Published: Mar 15, 2011
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.”
About DNA Genotek:
DNA Genotek focuses on providing high-quality biological sample collection products. The company’s Oragene family of products provides the best way to collect and preserve large amounts of DNA or RNA from saliva. The company also offers a family of products for collecting DNA from animals and livestock. The reliability and ease-of-use of the company’s products have resulted in rapid adoption at top-tier health research institutions globally, including Harvard, Stanford, Cambridge, and Johns Hopkins. DNA Genotek markets its products worldwide and has established a global customer base in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com
For information about this press release contact:
Shauna White DNA Genotek Inc. 613-723-5757 ext. 307 firstname.lastname@example.org
® Oragene is a registered trademark of DNA Genotek Inc.