OraSure’s OMNIgene®·ORAL Device Included in EUA Granted to Clinical Reference Laboratory for Self-Collected SARS-CoV-2 S...
July 31 2020 - 12:15PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices, and
microbiome laboratory and analytical services, today announced that
its OMNIgene®·ORAL (OM-505) saliva collection device is included in
the U.S. Food and Drug Administration (FDA) Emergency Use
Authorization (EUA) granted to Clinical Reference Laboratory (CRL),
one of the largest privately held clinical testing laboratories in
the United States, for SARS-CoV-2 testing. This is the fourth EUA
to include a collection device manufactured and sold by the
Company’s DNA Genotek subsidiary.
The EUA authorizes CRL to use the OMNIgene®·ORAL
device with CRL Rapid Response™, its saliva-based SARS-CoV-2 RT-PCR
test that can be self-collected at home, work or any other setting,
when COVID-19 infection is suspected by a healthcare provider. The
saliva sample would be collected with the OMNIgene·ORAL (OM-505)
saliva collection device, which is specifically designed for
self-collection, stabilization, storage and shipment of samples to
the laboratory. The OMNIgene·ORAL device offers improvements
over the standard nasopharyngeal swab because virtually anyone can
collect a saliva sample at home with no discomfort and return it to
the lab for processing, allowing personnel and protective equipment
to be saved for when they are most needed.
“As many companies begin the delicate task of
lifting stay-at-home orders and allowing businesses to reopen,
testing will help keep people safe and help get the economy back up
and running,” said Robert Thompson, CEO of Clinical Reference
Laboratory. “The DNA Genotek OMNIgene·ORAL device was the ideal
choice for our CRL Rapid Response test as our studies demonstrated
it to be more sensitive and accurate than the standard COVID-19
anterior nasal swab test.”
“This EUA highlights the benefits of saliva
collected with OMNIgene·ORAL as a sample type for COVID-19
diagnostics in the CRL Rapid Response test kit, due to its
performance as well as its safe and easy to use format, suitable
for unsupervised home collection,” said Kathleen Weber, Executive
Vice President, Business Unit Leader, Molecular Solutions
at DNA Genotek. “A global challenge like coronavirus requires
the commitment and cooperation of everyone who has the ability to
help address it. We are pleased to support CRL in their work in
expanding the availability of COVID-19 diagnostics.”
About OraSure Technologies
OraSure Technologies empowers the global
community to improve health and wellness by providing access to
accurate, essential information. Together with its wholly-owned
subsidiaries, DNA Genotek, Diversigen, CoreBiome (now
operating under the Diversigen brand), UrSure and Novosanis,
OraSure provides its customers with end-to-end solutions that
encompass tools, services and diagnostics.
The OraSure family of companies is a leader in the
development, manufacture, and distribution of rapid diagnostic
tests, sample collection and stabilization devices, and molecular
services solutions designed to discover and detect critical medical
conditions. OraSure’s portfolio of products is sold globally to
clinical laboratories, hospitals, physician’s offices, clinics,
public health and community-based organizations, research
institutions, government agencies, pharma, commercial entities and
direct to consumers. For more information on OraSure
Technologies, please visit www.orasure.com.
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure
Technologies, Inc., focuses on providing high-quality biological
sample collection products and end-to-end services for human
genomics and microbiome applications. The Company's Oragene®•Dx and
ORAcollect®•Dx product lines are the first and only FDA 510(k)
cleared saliva-based DNA collection devices for in vitro diagnostic
use. DNA Genotek also offers Research Use Only products to collect
and preserve large amounts of DNA or RNA from multiple sample
types. 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.
Investor
Contact: Sam Martin Argot Partners 212-602-1902
orasure@argotpartners.com |
Media
Contact:Jeanne MellVP Corporate
Communications484-353-1575media@orasure.com |
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