OraSure Technologies Receives BARDA Contract for Rapid Oral Fluid Pan-SARS-Coronavirus In-home Self-test
2020年4月6日 - 7:00PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices and
microbiome laboratory and analytical services, today announced it
has been awarded a $710,310 contract from the Biomedical Advanced
Research and Development Authority (BARDA), part of the Department
of Health and Human Services (HHS), to develop a
pan-SARS-coronavirus antigen rapid in-home self-test that uses oral
fluid samples. This support from BARDA will enable OraSure to
file for FDA Emergency Use Authorization (EUA) allowing for an
in-home self-test to debut into the U.S. market.
Built on OraSure’s OraQuick® platform, the rapid
test would allow for in-home self-testing by lay users as well as
by medical professionals. OraSure’s portable rapid test platform
uses an oral fluid sample and provides results in 20 minutes.
No instrumentation or trained personnel would be needed to
administer the test or to read the results. OraSure has a
well-documented history of success with in-home infectious disease
testing; the Company’s oral fluid self-test for HIV has been used
to diagnose millions of people around the world and connect them to
life-saving care.
Once developed and the necessary approvals are
obtained, an in-home self-test for SARS-coronavirus would help
alleviate the pressure on over-burdened healthcare systems.
Healthcare providers, retailers, and online vendors could ship
tests directly to an individual’s home, eliminating unnecessary
trips to hospitals, doctors’ offices, and testing facilities. This
would help maintain social distancing and curb the spread of
coronavirus through symptomatic and asymptomatic transmission.
Rapid in-home testing could also ease the burden on lab-based
testing.
Most current coronavirus tests require a
nasopharyngeal or oropharyngeal sample, which can be painful to
collect and difficult to attain through self-sampling. An effective
test based on an oral sample that can be used in home would enable
an easier and pain-free sample collection, as well as much wider
access to testing.
A rapid antigen test would also aid in screening
initiatives to identify individuals with acute COVID-19 infection
with or without symptoms, allowing immediate follow-up access to
the patient for further testing and/or quarantine and treatment if
necessary.
OraSure envisions a rapid development cycle of
approximately 4-6 months prior to seeking Emergency Use
Authorization (EUA).
“Lives and global economies are at stake. It’s
crucial that we understand just how many people are infected with
SARS-coronavirus,” said OraSure President and Chief Executive
Officer Stephen S. Tang, Ph.D. “In-home self-testing will
dramatically increase the capacity for SARS-coronavirus testing and
give our healthcare systems and labs some much-needed breathing
room. We believe that the development of an easy-to-use device that
delivers accurate results to individuals in their homes can play a
significant role in impacting infection rates. We are proud to
bring our expertise with quality, rapid, oral fluid self-tests to
the battle against the COVID-19 pandemic.”
“We need to put tests into people’s hands to
know their infection status and protect their loved ones. At
BARDA, we are continually looking for transformative technologies
to combat public health threats, and rapid at-home coronavirus
testing would be a game-changer,” said BARDA Director Rick Bright,
Ph.D. “We know that people can spread COVID-19 without showing any
symptoms, and with rapid at-home testing people could take
immediate action to prevent the spread of the virus.”
The pan-SARS-coronavirus antigen rapid in-home
self-test project has been funded in whole or in part with Federal
funds from the Department of Health and Human
Services, Office of the Assistant Secretary for Preparedness
and Response; Biomedical Advanced Research and Development
Authority, under Contract No. 75A50120C00061.
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.
Important Information
This 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; 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 Securities and Exchange Commission (“SEC”)
filings, including our registration statements, Annual Report on
Form 10-K for the year ended December 31, 2019, Quarterly
Reports on Form 10-Q, 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 we undertake no duty to update these statements.
Company
contacts: |
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Roberto Cuca |
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Jeanne Mell |
Chief Financial Officer |
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VP Corporate
Communications |
610-882-1820 |
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484-353-1575 |
Investorinfo@orasure.com |
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media@orasure.com |
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