OraSure’s OMNIgene®·ORAL Kit Included in EUA Granted to P23 Labs for At-Home Collection of Saliva Samples for SARS-CoV-2...
22 Maggio 2020 - 1:00PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices, and
microbiome laboratory and analytical services, (NASDAQ: OSUR),
announced today that its OMNIgene®·ORAL saliva collection device
(OM-505) was included in the U.S. Food and Drug Administration
(FDA) Emergency Use Authorization (EUA) granted to P23 Labs. This
EUA permits individuals to self-collect saliva specimens at-home
for the detection of SARS-CoV-2.
The P23 Labs’ TaqPath SARS-CoV-2 assay, combined with
OMNIgene®·ORAL (OM-505), facilitates the detection of nucleic acid
from SARS-CoV-2 using oral fluid samples self-collected at-home
with telemedicine support or in an assisted living setting, at a
doctor’s office or at a drive through collection site. A product of
OraSure’s DNA Genotek subsidiary, OMNIgene®·ORAL (OM-505) is an
all-in-one collection kit for the detection of DNA and RNA from
viruses.
This is the second EUA that utilizes a DNA Genotek collection
device. Earlier this month, the Company’s ORAcollect®·RNA kit
(OR-100) was included as the collection device for anterior nares
(nasal) samples EUA granted to Biocerna LLC for its PCR-based
SARS-CoV-2 assay.
“OraSure is on the cutting edge of the fight against the
COVID-19 pandemic. Our innovative and non-invasive saliva
collection kits are designed to make it easier and safer to test
for COVID-19, including use in home settings,” said Kathleen
Weber, Executive Vice President, Business Unit Leader, Molecular
Solutions at DNA Genotek. “P23 Labs was able to leverage the
usability studies for our Oragene®·Dx general 510(k) clearance to
reduce the time required for submitting their EUA. We are proud of
our on-going commitment to regulatory compliance which provides our
customers with a high degree of confidence in our medical device
products.”
At-home self-collection with telemedicine support enables
individuals to self-administer sample collection. This reduces the
risk of virus transmission to others and lowers the demand for
personal protective equipment (PPE) for health care providers, as
the test does not require an in-person visit with a clinician.
“P23 is focused on providing testing options to populations that
are currently underserved by the testing options available today.
This EUA with DNA Genotek’s collection device will enable testing
for people that do not have the ability to get to a collection
center or are at home because they are sick, quarantined, at
increased risk for infection or simply concerned about exposing
themselves by traveling to a collection site,” said Eddie McIntyre,
Executive Vice President, Technology and Logistics, at P23 Labs.
“The device’s intuitive ease-of-use facilitates minimally
supervised or in most cases complete self-collection and is a
tremendous advance to current COVID-19 sample collection
methods.”
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) 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 GenotekDNA 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.
About P23 LabsP23 Labs is a high-complexity
molecular diagnostics laboratory that specializes in diagnostic
testing of infectious disease. P23 Labs offers a full suite of
molecular diagnostic tests that also include COVID-19. P23’s
dedication to the response to the coronavirus pandemic includes
respiratory pathogen profiles, and other infectious diseases using
our state-of-the-art molecular methods. P23 has created a quality
laboratory that focuses on fortifying the relationship of patients
and providers by removing barriers to healthcare. P23’s staff have
a combined 150 plus years of experience in genetics, epidemiology,
business, finance, and clinical medical practice. P23 Labs combine
innovation, quality, and creativity with science and information
technology to emerge as a leader in molecular testing. P23 Labs is
in Little Rock, AR. For more information visit www.p23labs.com.
Company contact:
Sam Martin |
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Jeanne Mell |
Argot Partners |
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VP Corporate Communications |
212-600-1902 |
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484-353-1575 |
Orasure@argotpartners.com |
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media@orasure.com |
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