OraSure’s ORAcollect®·RNA Device Included in EUA Granted to Quadrant Biosciences Inc. for COVID-19 Test
September 24 2020 - 6:00AM
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) saliva collection device has been
included in the U.S. Food and Drug Administration (FDA) Emergency
Use Authorization (EUA) granted to Quadrant Biosciences Inc. for a
COVID-19 laboratory test. Under the EUA, the ORAcollect®·RNA
(OR-100) device can be used to collect saliva samples from
individuals suspected of COVID-19 infection by a healthcare
professional. This is the sixth EUA to include a collection device
from the Company’s DNA Genotek subsidiary and the first to
exclusively utilize a saliva collection method.
Quadrant’s Clarifi COVID-19 Test Kit, developed
in partnership with SUNY Upstate Medical University, leverages the
company’s established expertise in RNA-based diagnostics. The
non-invasive, and easy to administer, saliva swab test determines
the presence or absence of SARS-CoV-2 viral RNA, and will be
immediately available for use by high-complexity clinical
laboratories serving patients through physicians' offices, urgent
care clinics and hospitals.
“Expansion of testing is a key to helping slow
the spread of COVID-19 and safely reopen economies. That’s why DNA
Genotek is leveraging our expertise in non-invasive sample
collection to provide more devices to more testing facilities, to
help check millions of people around the world for COVID-19,” said
Kathleen Weber, Executive Vice President, Business Unit Leader,
Molecular Solutions at DNA Genotek. “DNA Genotek, now with six EUAs
that include our collection kits, has emerged as a leading company
helping to detect the virus.”
“We are thrilled that the FDA has issued the
Clarifi COVID-19 test EUA approval for use in the diagnosis of
COVID-19,” said Richard Uhlig, Founder and CEO of
Quadrant Biosciences. “The coronavirus has had a devastating
effect on health and welfare worldwide, so it is extremely
gratifying for us to take the expertise we have gained working on
RNA diagnostic tests for other health conditions, such as autism
spectrum disorder and Parkinson's disease, and apply that expertise
to the development of this critically important test.”
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.comImportant
InformationThis press release contains certain
forward-looking statements, including with respect to expected
revenues and earnings/loss per share. Forward-looking statements
are not guarantees of future performance or results. Known and
unknown factors that could cause actual performance or results to
be materially different from those expressed or implied in these
statements include, but are not limited to: ability to successfully
manage and integrate acquisitions of other companies in a manner
that complements or leverages our existing business, or otherwise
expands or enhances our portfolio of products and our end-to-end
service offerings, and the diversion of management’s attention from
our ongoing business and regular business responsibilities to
effect such integration; the expected economic benefits of
acquisitions (and increased returns for our stockholders),
including that the anticipated synergies, revenue enhancement
strategies and other benefits from the acquisitions may not be
fully realized or may take longer to realize than expected and our
actual integration costs may exceed our estimates; impact of
increased or different risks arising from the acquisition of
companies located in foreign countries; ability to market and sell
products, whether through our internal, direct sales force or third
parties; impact of significant customer concentration in the
genomics business; failure of distributors or other customers to
meet purchase forecasts, historic purchase levels or minimum
purchase requirements for our products; ability to manufacture
products in accordance with applicable specifications, performance
standards and quality requirements; ability to obtain, and timing
and cost of obtaining, necessary regulatory approvals for new
products or new indications or applications for existing products;
ability to comply with applicable regulatory requirements; ability
to effectively resolve warning letters, audit observations and
other findings or comments from the U.S. Food and Drug
Administration (“FDA”) or other regulators; the impact of the novel
coronavirus (“COVID-19”) pandemic on our business and our ability
to successfully develop new products, validate the expanded use of
existing collector products and commercialize such products for
COVID-19 testing; changes in relationships, including disputes or
disagreements, with strategic partners or other parties and
reliance on strategic partners for the performance of critical
activities under collaborative arrangements; ability to meet
increased demand for the Company’s products; impact of replacing
distributors; inventory levels at distributors and other customers;
ability of the Company to achieve its financial and strategic
objectives and continue to increase its revenues, including the
ability to expand international sales; ability to identify,
complete, integrate and realize the full benefits of future
acquisitions; impact of competitors, competing products and
technology changes; reduction or deferral of public funding
available to customers; competition from new or better technology
or lower cost products; ability to develop, commercialize and
market new products; market acceptance of oral fluid or urine
testing, collection or other products; market acceptance and uptake
of microbiome informatics, microbial genetics technology and
related analytics services; changes in market acceptance of
products based on product performance or other factors, including
changes in testing guidelines, algorithms or other recommendations
by the Centers for Disease Control and Prevention (“CDC”) or other
agencies; ability to fund research and development and other
products and operations; ability to obtain and maintain new or
existing product distribution channels; reliance on sole supply
sources for critical products and components; availability of
related products produced by third parties or products required for
use of our products; impact of contracting with the U.S.
government; impact of negative economic conditions; ability to
maintain sustained profitability; ability to utilize net operating
loss carry forwards or other deferred tax assets; volatility of the
Company’s stock price; uncertainty relating to patent protection
and potential patent infringement claims; uncertainty and costs of
litigation relating to patents and other intellectual property;
availability of licenses to patents or other technology; ability to
enter into international manufacturing agreements; obstacles to
international marketing and manufacturing of products; ability to
sell products internationally, including the impact of changes in
international funding sources and testing algorithms; adverse
movements in foreign currency exchange rates; loss or impairment of
sources of capital; ability to attract and retain qualified
personnel; exposure to product liability and other types of
litigation; changes in international, federal or state laws and
regulations; customer consolidations and inventory practices;
equipment failures and ability to obtain needed raw materials and
components; the impact of terrorist attacks and civil unrest; and
general political, business and economic conditions. These and
other factors that could affect our results are discussed more
fully in our SEC filings, including our registration statements,
Annual Report on Form 10-K for the year ended December 31, 2019,
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020,
and other filings with the SEC. Although forward-looking statements
help to provide information about future prospects, readers should
keep in mind that forward-looking statements may not be reliable.
Readers are cautioned not to place undue reliance on the
forward-looking statements. The forward-looking statements are made
as of the date of this press release and OraSure Technologies
undertakes no duty to update these statements.
Investor
Contact:Sam MartinArgot
Partners212-602-1902orasure@argotpartners.com |
Media
Contact:Jeanne MellVP Corporate
Communications484-353-1575media@orasure.com |
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