OraSure’s ORAcollect®·RNA Device Included in EUA Granted to MiraDx Inc. for SARS-CoV-2 Test
September 03 2020 - 4:30PM
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 ORAcollect®·RNA (OR-100) collection device was included along
with other devices in the U.S. Food and Drug Administration (FDA)
Emergency Use Authorization (EUA) granted to MiraDx Inc., a Los
Angeles-based molecular genetics company. This is the fifth EUA to
include a collection device from the company’s DNA Genotek
subsidiary.
MiraDx will utilize ORAcollect®·RNA to collect oropharyngeal
samples in their COVID-19 testing program for essential workers and
first responders to help slow, and hopefully prevent, the spread of
COVID-19. Samples are collected under the supervision of a
healthcare professional.
MiraDx is performing COVID-19 PCR-based viral detection
testing in their CLIA-certified, high-complexity
molecular diagnostics laboratory that can provide 24-48 hour
turnaround time. The MiraDx SARS-CoV-2 assay, combined with
ORAcollect®·RNA, facilitates the detection of nucleic acid from
SARS-CoV-2 using highly sensitive quantitative PCR technology.
“There’s an urgent need for COVID-19 testing so that people who
are infected can be easily and quickly identified,” said Joanne
Weidhaas, Founder, MiraDx Inc. "Reliable, high-quality testing is
essential to help healthcare systems overcome this pandemic. We are
focused on delivering the highest quality, most sensitive and
dependable testing possible.”
“Making rapid and accurate diagnostic tools available is
critical for early detection and control of COVID-19," said
Kathleen Weber, Executive Vice-President, Business Unit Leader,
Molecular Solutions at DNA Genotek. “Our global leadership in
molecular collection devices has enabled MiraDx to utilize a highly
accurate collection device to detect genetic material from
SARS-CoV-2. With our legacy of innovation and unique capabilities
in molecular diagnostics, we’re in a strong position to help
provide a diagnostic tool for the COVID-19 public health
challenge.”
MiraDx was spun out of Yale University in 2009 by scientists and
clinicians seeking advances in the field of personalized medicine
and treatment based on microRNA-based genetic testing.
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 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.
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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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