OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that it has been awarded a $109
million contract from the U.S. Department of Defense (DOD), in
coordination with the Department of Health and Human Services
(HHS), to build additional manufacturing capacity in the United
States for InteliSwab™ COVID-19 rapid tests as part of the nation’s
pandemic preparedness plan.
InteliSwab is a remarkably simple test that
rapidly detects active COVID-19 infection. It was granted three
Emergency Use Authorizations (EUAs) by the Food and Drug
Administration (FDA) in June for professional point-of-care use,
prescription (Rx) home use, and over-the-counter (OTC) use.
“The U.S. government’s selection of OraSure’s
InteliSwab™ rapid test for this national pandemic preparedness
effort is a great honor and ensures we can make the necessary
investments to scale manufacturing in order to support our nation’s
pandemic response,” said OraSure President and CEO Stephen Tang,
Ph.D. “This test will play a key role in ensuring our nation is
prepared to continue the fight against this, and possible future
pandemics and potential resurgences in disease activity.”
The federal funding will expand OraSure’s
production capacity by 100 million tests annually, by March 2024.
An existing OraSure location in Bethlehem, Pennsylvania, will be
retrofitted to accommodate increased manufacturing and an
additional new facility will be added in another U.S. location to
be determined. In addition to this contract, OraSure also has
internally funded expansion plans to achieve 120 million tests
annually by the second quarter of 2022.
A recent study by the National Institutes of
Health shows rapid antigen tests perform on par with lab PCR tests
when testing at least twice per week with the antigen test.1
“Home testing options prevent the risk of
further spread of the virus, and minimize the burden on the
individual, making them an ideal cornerstone of any national
pandemic preparedness strategy,” Tang said. “As a company we stand
ready to aid in the government’s efforts to allow individuals to
return to work and school safely. Beyond that, this funding will
allow OraSure to respond to future public health crises.”
Multiple government agencies, including the DOD
and HHS are working to address COVID-19 testing needs. Development
of the InteliSwab™ COVID-19 Rapid Test 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,
Division of Research, Innovation and Ventures under contract number
75A50120C00061, utilizing Health Care Enhancement Act (HCEA)
funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the
manufacturing expansion effort for the InteliSwab™ COVID-19 rapid
test in coordination with the Department of the Air Force’s
Acquisition COVID-19 Task Force (DAF ACT). This effort was funded
through the American Rescue Plan Act (ARPA) to enable and support
domestic industrial base expansion for critical medical resources.
1 Longitudinal assessment of diagnostic test performance over the
course of acute SARS-CoV-2 infection, The Journal of Infectious
Diseases, 2021; jiab337, https://doi.org/10.1093/infdis/jiab337
About
InteliSwab™OraSure has received Emergency
Use Authorizations (EUA) from the U.S. Food and Drug Administration
(FDA) for its InteliSwab™ COVID-19 rapid tests. The FDA has
authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter
(OTC) use without a prescription. FDA has also authorized the
InteliSwab™ COVID-19 Rapid Test Pro for professional use in point
of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid
Test Rx for Prescription Home Use. These remarkably simple COVID-19
lateral flow tests use samples self-collected from the lower
nostrils. InteliSwab™’s unique design incorporates a built-in swab
fully integrated into the test stick. After users swab their lower
nostrils, the test stick is swirled in a pre-measured buffer
solution, and the result appears right on the test stick within 30
minutes, with no instruments, batteries, smartphone or laboratory
analysis needed to see the result. With less than one minute of
“hands-on time,” it is as simple as Swab, Swirl, and See.
This product has not been FDA cleared or
approved; but authorized by the FDA under an EUA; This product has
been authorized only for the detection of proteins from SARS-CoV-2,
not for any other viruses or pathogens; and, This product is only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21
U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
OraSure’s Response to
COVID-19OraSure is leveraging its expertise in infectious
disease testing and molecular sample collection with EUAs for rapid
antigen self testing and molecular sample collection for PCR-based
tests. The Company’s portfolio of COVID-19 tests and collection
kits all feature easy, convenient, pain-free self-collection, and
help increase access to testing, while alleviating the burden on
the healthcare system and minimizing exposure risks.
About OraSure
TechnologiesOraSure Technologies empowers the global
community to improve health and wellness by providing access to
accurate, essential information. OraSure, together with its
wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis,
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, products, product development activities, regulatory
submissions and authorizations and other matters. 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, receive necessary regulatory approvals
and authorizations 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, 2020,
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 OraSure Technologies undertakes no duty
to update these statements.
Investor Contact: |
|
Media Contact: |
Scott Gleason |
|
Amy Koch |
SVP Investor Relations & Corporate Communications |
|
Sr. Mgr. Corporate Communications |
484-425-0588 |
|
484-523-1815 |
sgleason@orasure.com |
|
media@orasure.com |
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