OraSure Technologies Subsidiary, DNA Genotek Receives FDA 510(k) Clearance for Oragene(R) Dx Collection Device

DNA Genotek, a subsidiary of OraSure Technologies, received FDA clearance to market the Oragene Dx saliva DNA collection device. According to the company this is the first 510(k) approval for a DNA collection and stabilization device.Oragene Dx DNA Collection Device

The device promises reliable collection of DNA samples and the ability to use it to transport and store the samples for an extended time period.

  • Painless, non-invasive collection
  • Median A260/280 of 1.7‡
  • Easy collection and transportation
  • Oragene•Dx/saliva samples are stable for long-term room temperature storage
  • Standardized tube format
  • Oragene•Dx solution is bacteriostatic

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.”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


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