Photo Release -- OraSure Technologies Subsidiary, DNA Genotek Receives FDA 510(k) Clearance for Oragene(R) Dx Collection Device
08 12월 2011 - 8:00PM
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.
A photo accompanying this release is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=11212
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.
The OraSure Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6440
CONTACT: Investor Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
investorinfo@orasure.com
Media Contact:
Shauna White
DNA Genotek Inc.
613-723-5757 ext. 307
shauna.white@dnagenotek.com
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