U.S. FDA Authorizes InteliSwab™ COVID-19 Rapid Tests for OTC Single-Use, At-Home Testing for Symptomatic People and Accepts Data for Delta Variant Detection
02 Novembre 2021 - 12:05PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that the EUA for its InteliSwab™
COVID-19 rapid tests has been amended by the U.S. Food and Drug
Administration (FDA) to only require one test for individuals with
symptoms of COVID-19. Previously, the at-home test was authorized
for over-the-counter use in people with or without symptoms when
tested twice with at least 24 hours but not more than 36 hours
between tests, which is called serial testing. Now, people with
symptoms only need to test once; people without symptoms should
still perform serial testing if they get a negative result on their
first test.
In addition, OraSure conducted studies using
live SARS-CoV-2 virus at independent laboratories which showed
detection of all variants of concern, including the Delta variant.
The FDA reviewed the data submitted by OraSure regarding the
detection of the SARS-CoV-2 Delta variant and indicated that the
data was adequate, and that no further data is required.
“These studies in independent labs clearly show
the InteliSwab™ tests detect variants, including the Delta variant
that roared through the country late this summer, and this should
give people extra confidence in the accuracy of InteliSwab™,” said
OraSure President and CEO Stephen Tang, Ph.D. “Beyond that, the
authorization of the InteliSwab™ COVID-19 Rapid Test to be used as
a one-time, over-the-counter test for people with COVID-19 symptoms
will help increase our nationwide availability of tests, ensuring
people who want rapid tests have access to them.”
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. 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 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. 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.
Multiple government agencies, including the U.S.
Department of Defense (DoD) and the U.S. 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 Biomedical Advanced
Research and Development Authority’s Division of Research,
Innovation and Ventures within HHS’ the Office of the Assistant
Secretary for Preparedness and Response 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
document 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 of the Company to manufacture sufficient
quantities of the InteliSwab™ COVID-19 rapid test; 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 collection 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 Securities and Exchange Commission (“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 we undertake 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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