OTTAWA, Dec. 8, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies', Inc. (Nasdaq:OSUR) subsidiary, DNA Genotek, a leading provider of products for biological sample collection, stabilization and preparation, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for DNA Genotek's Oragene•Dx collection device. Oragene•Dx is the first and only saliva DNA collection and stabilization device to receive 510(k) clearance.
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DNA Genotek's lead product line, Oragene, provides an all-in-one system for the collection, stabilization, and transportation of DNA from saliva. The product is currently used by thousands of academic and research customers in over 100 countries worldwide. Oragene provides substantial advantages over traditional DNA collection methods such as blood or buccal swabs. These include the reliable collection of high quality DNA samples using a simple, non-invasive method and the ability to transport and store collected samples for extended periods at ambient temperatures.
Securing FDA 510(k) clearance of Oragene•Dx ensures that clinical diagnostic and personalized medicine test providers can now experience the benefits of Oragene using a family of products cleared for use by the FDA. This FDA clearance will provide added flexibility to diagnostic customers who wish to offer their patients the non-invasive, reliable and easy-to-use Oragene•Dx saliva sample collection device as an alternative to invasive blood collection. In addition, the FDA 510(k) clearance of Oragene•Dx will enable molecular diagnostic test manufacturers to streamline their own regulatory submissions and potentially broaden market accessibility for their genetic tests.
"We have responded to our customers' requests to integrate the utility and performance of Oragene with an FDA cleared status," said Ian Curry, President of DNA Genotek Inc. "The 510(k) clearance of Oragene•Dx should enhance patient access to genetic testing by offering proven, easy-to-use, non-invasive sample collection and stabilization. The clearance further demonstrates our longstanding commitment to produce high quality products that meet the demands of our customers."
Oragene•Dx is suitable for use in FDA cleared molecular diagnostic applications and was cleared using results from the eSensor® Warfarin Sensitivity Saliva Test.
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (Nasdaq:OSUR), focuses on providing high-quality biological sample collection, stabilization and preparation products. The company's Oragene®•Dx product line is the only FDA 510(k) cleared saliva-based DNA collection device for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from saliva for use with humans, animals or 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 a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In addition, through its wholly-owned subsidiary, DNA Genotek Inc., the Company also is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.
®Oragene is a registered trademark of DNA Genotek, Inc. All other trademarks are the property of their respective owners.
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