DNA Genotek’s ORAcollect®·RNA kit included in EUA granted to Biocerna SARS-CoV-2 test
2020年5月4日 - 7:00PM
DNA Genotek Inc., a leading provider of sample collection kits and
end-to-end services and a wholly-owned subsidiary of OraSure
Technologies, Inc. (NASDAQ: OSUR), announced today that its
ORAcollect®·RNA kit (OR-100) was included as the collection device
for anterior nares (nasal) samples under a U.S. Food and Drug
Administration (FDA) Emergency Use Authorization (EUA) granted to
Biocerna LLC for its PCR-based SARS-CoV-2 assay.
The Biocerna assay, combined with the
ORAcollect®·RNA collection kit, is designed to allow for
self-collection of nasal samples for the purpose of detecting the
SARS-CoV-2 genome using the ThermoFisher Scientific TaqPath
COVID-19 Combo Kit under the supervision of a healthcare provider.
ORAcollect®·RNA is an all-in-one system for the collection,
stabilization and transportation of human, microbial and viral
RNA.
“We are pleased with the recognition our
ORAcollect®·RNA collection kit has received as part of this
Emergency Use Authorization granted to Biocerna,” said Kathleen
Weber, Executive Vice President, Business Unit Leader Molecular
Solutions at DNA Genotek. “We believe our collection kits can be a
valuable tool for use in conjunction with a variety of SARS-CoV-2
assays and are proud that we can be a part of Biocerna’s efforts in
bringing new testing solutions to the fight against COVID-19.”
“It was important for us to offer innovative
specimen collection options to our clients which will help minimize
the exposure of their healthcare providers to the SARS-CoV-2 virus
and reduce use of PPE. ORAcollect®·RNA allows for us to provide an
easy-to-use and minimally invasive collection kit that provides
excellent performance in detecting the virus, works seamlessly with
our automated laboratory workflow and allows for shipping of
specimens to our laboratory without the use of cold packs,” said
Chris Sanders, Founder and CEO, Biocerna.
OraSure Technologies, Inc., DNA Genotek’s parent
company, is developing a pan-SARS-coronavirus antigen rapid in-home
self-test that uses oral fluid samples, and a lab-based oral fluid
microplate coronavirus antibody enzyme-linked immunosorbent assay
(ELISA). “We are proud to bring our experience with sample
collection and infectious disease diagnostics to bear in the battle
against COVID-19. Improving and increasing the capacity of COVID-19
testing is crucial to controlling the pandemic and restarting the
global economy,” said Stephen S. Tang, Ph.D., President and CEO of
OraSure.
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
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, CoreBiome, Diversigen 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.
Company contact: |
|
|
Roberto Cuca |
Jeanne Mell |
Chief Financial Officer |
VP Corporate Communications |
610-882-1820 |
484-353-1575 |
Investorinfo@orasure.com |
media@orasure.com |
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