OraSure’s Oragene®•Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test
08 June 2020 - 10:00PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices, and
microbiome laboratory and analytical services, announced today that
Phosphorus Diagnostics, a leader in diagnostic and bioinformatic
solutions for clinical next generation sequencing (NGS), was
granted an Emergency Use Authorization (EUA) by the U.S. Food and
Drug Administration (FDA) allowing individuals to self-collect
saliva specimens with the Company’s Oragene®•Dx (OGD-510)
collection kit for the detection of SARS-CoV-2 using the Phosphorus
COVID-19 RT-qPCR test.
The Phosphorus COVID-19 RT-qPCR test detects
nucleic acid from SARS-CoV-2 in the saliva of individuals who are
suspected of being infected with COVID-19 by a healthcare
professional. Combined with the easy-to-use Oragene®•Dx (OGD-510)
saliva collection device from OraSure’s subsidiary, DNA Genotek,
this is an easily deployable testing option for patient or employee
populations and for at-home use. Eligibility to receive an
Oragene®•Dx collection device for in-home self-collection will be
determined based on a medical questionnaire reviewed by a
healthcare professional before shipment.
This is the third EUA for SARS-CoV-2 testing
that utilizes a DNA Genotek collection device and the first that
allows a fully at-home, unsupervised collection solution utilizing
a DNA Genotek device. Earlier this month, the Company’s
ORAcollect®•RNA kit (OR-100) was included as the collection device
for the EUA granted to Biocerna LLC. The Company’s OMNIgene®•ORAL
(OM-505) was included in the EUA recently granted to P23 Labs.
“DNA Genotek continues to find new ways to help
patients and healthcare providers fight the COVID-19 crisis through
our leading saliva-based collection devices,” said Kathleen Weber,
Executive Vice President, Business Unit Leader, Molecular Solutions
at DNA Genotek. “Our at-home collection kits are designed to make
it easier and safer to self-collect samples during this important
time. Working with the FDA, regulatory bodies around the world, and
laboratories like Phosphorus, we are committed to expanding the
availability of saliva-based collection devices to prevent the
spread of this disease.”
Alexander Bisignano, CEO at Phosphorus said, “We
chose to validate our RT-qPCR COVID-19 test with saliva due to its
ease-of-use in at-home settings and reliability as a sample type.
The Phosphorus COVID-19 RT-qPCR assay, combined with OraSure’s
Oragene®•Dx (OGD-510), makes testing easy, painless and reliable,
enabling the widespread usage necessary to combat and contain this
disease. In addition to at-home usage, Phosphorus is also
partnering with clinicians and employers to provide viral and
antibody testing solutions that enable re-opening of workplaces and
clinical care.”
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
Investor
Contact: |
Media
Contact: |
Sam Martin |
Jeanne Mell |
Argot Partners |
VP Corporate Communications |
212-602-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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