OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that the Biomedical Advanced Research
Development Authority (BARDA), part of the office of the Assistant
Secretary for Preparedness and Response at the U.S. Department of
Health and Human Services (HHS), will provide up to $13.6 million
in funding for the Company to obtain 510(k) clearance and Clinical
Laboratory Improvement Amendments (CLIA) waiver for OraSure’s
InteliSwab™ COVID-19 rapid test from the Food and Drug
Administration (FDA).
InteliSwab™ is a simple “swab, swirl, and see”
test that uses an integrated swab to self-collect a sample from the
lower nostrils. The result appears right on the test stick within
30 minutes, with no instruments, batteries, smartphone or
laboratory analysis needed. It has three Emergency Use
Authorizations from the Food and Drug Administration for
professional point-of-care use, prescription (Rx) home use, and
over-the-counter (OTC) use.
“Rapid COVID-19 antigen tests can help to
facilitate containment and minimize outbreaks by detecting those
individuals infected with COVID-19. Testing with InteliSwab™ is
expected to be an important component of governments’, private
industries’ and communities’ response to the COVID-19 pandemic,
along with vaccination and protection,” said OraSure President and
CEO, Stephen Tang, Ph.D. “Once received, this full regulatory
clearance will help ensure continued availability of the
InteliSwab™ COVID-19 Rapid Test long-term.”
The InteliSwab™ COVID-19 Rapid Test is
authorized for emergency use for the duration of the public health
declaration. With FDA 510(k) clearance, InteliSwab™ can continue to
be marketed without a public health emergency declaration from the
Secretary of the Department of Health and Human Services (HHS). To
date, there are no COVID-19 rapid antigen tests with 510(k)
clearance and the requirements for 510(k) clearance are expected to
be more stringent than the requirements for EUA.
Following 510(k) clearance, the Company will
pursue Clinical Laboratory Improvement Amendments (CLIA) waiver for
InteliSwab™, ensuring the test can continue to be performed by an
untrained user outside of the laboratory setting.
This project has been funded in whole or in part
with federal funds from BARDA, part of the U.S. Department of
Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response under contract number 75A50120C00061.
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 the 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 InformationThis 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 |
OraSure Technologies (NASDAQ:OSUR)
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