OraSure Technologies Submits COVID-19 Rapid Antigen Prescription Home Self-Test and Professional Test to FDA for Emergency Us...
March 30 2021 - 7:00AM
OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it
has submitted an application to the U.S. Food and Drug
Administration (FDA) for Emergency Use Authorization (EUA) of its
COVID-19 rapid antigen test for both Prescription Home Use, and
Professional Use in point of care (POC) settings.
These lateral flow, rapid diagnostic tests are
designed to detect active COVID-19 infection with a simple,
easy-to-use workflow, using samples self-collected from the lower
nostrils. After users swab their lower nostrils, the test stick is
swirled in a pre-measured buffer solution. No instrumentation,
batteries, smart phone or laboratory analysis is needed to read the
result, which appears on the test stick a short time later.
“We believe our rapid antigen tests will be well
received in the market thanks to their simplicity and ease of use.
We also have the proven experience and capabilities to manufacture
at scale to meet demand. With the race between vaccines and
variants ongoing, testing will continue to play a crucial role in
reopening workplaces, schools and other places where people
gather,” said Stephen Tang, Ph.D., President and CEO of OraSure
Technologies. “I’m delighted that we were able to accelerate the
submission of the Prescription Home Self-Test. At-home testing will
make it easier for individuals to safely and quickly know if they
are infectious, and self-isolate to minimize transmission.”
Subject to receipt of Emergency Use
Authorization, the Company intends to market a COVID-19
Prescription Home Self-Test and a Professional Test for use in POC
settings. With a simple design and straightforward workflow,
OraSure’s tests are well suited for use by individuals at home, as
well as by health care providers, employers, pharmacies,
universities, and deployment into underserved communities when
prescribed by a healthcare provider.
ManufacturingOraSure has
started manufacturing the COVID-19 rapid antigen test in parallel
with EUA submission. The Company has well-established manufacturing
capabilities, having produced over 80 million rapid HIV, HCV and
Ebola tests. OraSure is in the midst of a manufacturing capacity
expansion that will bring annual capacity for its rapid tests from
55 million tests at the end of the first quarter to 70 million
tests beginning in the third quarter of 2021, and further to 120
million units per year by the second quarter of 2022. Included in
these numbers are approximately 17 million of the Company’s
existing tests for HIV, HCV and Ebola.
OraSure’s Response to the COVID-19
Pandemic OraSure is leveraging its expertise in infectious
disease testing and molecular sample collection to advance COVID-19
testing and sample collection solutions across three modalities:
Molecular/PCR, Antibody and Antigen. The Company’s portfolio of
COVID-19 tests and collection kits all feature convenient,
pain-free self-collection, and help increase access to testing,
alleviate the burden on the healthcare system, minimize exposure
risks and conserve personal protective equipment (PPE).
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:Sam MartinArgot
Partners212-600-1902 orasure@argotpartners.com
Media contact: Jeanne Mell OraSure Technologies
484-353-1575media@orasure.com
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