OraSure Technologies Provides Update on Its Emergency Use Authorization Application for Its Lab-based Oral Fluid SARS-CoV-2 ...
December 21 2020 - 4:01PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests and specimen collection devices,
today disclosed that the U.S. Food and Drug Administration (FDA)
has requested additional information as part of its review of the
Company’s application for Emergency Use Authorization (EUA) for its
laboratory-based oral fluid SARS-CoV-2 antibody test. The OraSure
SARS-CoV-2 Antibody ELISA is intended for qualitative detection of
total antibodies to SARS-CoV-2 in human oral fluid specimens
collected with the OraSure Oral Antibody Collection Device.
At the FDA’s request, the Company intends to resubmit two
separate EUAs for the ELISA and the oral specimen collection
device. In addition, the FDA has requested that additional
analytical studies be conducted on sample collection and
stability.
“To date, there are no oral fluid antibody tests
for COVID-19 authorized for sale in the U.S. As such, FDA’s
guidance on EUA submissions for COVID-19 antibody tests focuses on
blood samples for tests; the Agency did not outline specific
requirements for an oral fluid test. Consequently, we were unable
to completely anticipate all of the data that would be required for
a first-of-its-kind oral fluid antibody test,” said OraSure
President and CEO Stephen S. Tang, Ph.D. “This request is within
the normal course of an FDA review and we are confident that we’ll
be able to provide the requested data, and resubmit our EUA
application for this pioneering product promptly.”
Antibody tests are well suited for community
surveillance and seroprevalence studies to identify people who have
antibodies against COVID-19. Oral sample collection is quick,
painless, non-invasive and requires less human contact than a blood
draw, minimizing the need for personal protective equipment and
reducing exposure to potentially infected patients.
About OraSure Technologies
OraSure Technologies empowers the global community to improve
health and wellness by providing access to accurate, essential
information. Together with its wholly-owned subsidiaries, DNA
Genotek, Diversigen, CoreBiome (now operating under the Diversigen
brand), UrSure and Novosanis, OraSure 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 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 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 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, 2019, Quarterly Report on Form 10-Q for the quarter ended
September 30, 2020, 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: |
Sam Martin |
Jeanne Mell |
Argot Partners |
VP Corporate Communications |
212-600-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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