OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that its InteliSwab® COVID-19 rapid
tests detect the Omicron variant as effectively as they detect the
original SARS-CoV-2 strain and other previous variants of concern,
including Delta, Alpha, Beta and Gamma. The Omicron variant studies
were conducted using live SARS-CoV-2 virus at an independent,
third-party laboratory and showed InteliSwab® detected the Omicron
variant at the same viral load levels, or limit of detection, as
previous variants that were tested.
“The global COVID-19 pandemic continues to
evolve, and we will continue to monitor the situation and test
InteliSwab® with all new variants of concern as they emerge,” said
Lisa Nibauer, President of Diagnostics for OraSure. “As the Omicron
variant erupts across the nation, this news should give consumers
even more confidence when using the InteliSwab® test.”
Testing with InteliSwab® is simple: users swab
their lower nostrils with the test stick, swirl it in a
pre-measured solution, and see their result on the test stick in 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.”
About InteliSwab®OraSure has
received Emergency Use Authorizations (EUA) from the 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. The FDA has also authorized the InteliSwab®
COVID-19 Rapid Test Pro for professional use in point of care (POC)
CLIA-waived settings, and the 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 end of the test stick.
This product has not been FDA cleared or
approved, but it has been authorized by the FDA under an EUA. The
emergency use of this product has been authorized only for the
detection of proteins from SARS-CoV-2, not for any other viruses or
pathogens. 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.
Multiple government agencies, including the U.S.
Department of Defense (DoD) and Department of Health and Human
Services (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 HHS; the
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.
OraSure’s Response to
COVID-19OraSure is leveraging its expertise in infectious
disease testing and molecular sample collection with EUAs for rapid
COVID-19 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 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: risk that the
Company's exploration of strategic alternatives may not result in
any definitive transaction or enhance stockholder value and may
create a distraction or uncertainty that may adversely affect
operating results, business or investor perceptions; the diversion
of management’s attention from the Company's ongoing business and
regular business responsibilities due to the Company's exploration
of strategic alternatives; ability to resolve the Company's ongoing
manufacturing challenges and satisfy customer demand; 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 the Company's business and 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; 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: Scott Gleason SVP Investor Relations &
Corporate Communications 484-425-0588 sgleason@orasure.com |
Media Contact: Amy Koch Sr. Mgr. Corporate Communications
484-523-1815 media@orasure.com |
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/836d2a58-cc8a-4e60-aad3-1764a2631dc5
OraSure Technologies (NASDAQ:OSUR)
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