OraSure Subsidiary DNA Genotek’s OMNIgene®·ORAL Saliva Collection Device Receives Health Canada Authorization for use in ...
January 28 2021 - 6:00AM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices, and
microbiome laboratory and analytical services, today announced its
OMNIgene®·ORAL (OME-505) saliva collection device, a product of
Ottawa-based subsidiary DNA Genotek, has received authorization
from Health Canada for use as a component in molecular diagnostic
tests for the detection of SARS-CoV-2. Diagnostic labs, provincial
and territory health authorities and COVID-19 test kit providers in
Canada now have access to a non-invasive and painless saliva
collection device to facilitate expansion of their COVID-19 testing
programs.
Health Canada’s Interim Order authorization of
OMNIgene®·ORAL (OME-505) will permit diagnostic
labs, provincial and territory health authorities and COVID-19 test
kit providers to offer testing more broadly, including for both
at-home self-collection and via healthcare professionals. Those
adding saliva to their workflow must validate the use of the
OMNIgene®•ORAL with their assay prior to
SARS-CoV-2 testing in accordance with applicable regulations.
“Widespread testing for COVID-19 is likely to
occur for the foreseeable future, with periods of intense testing
required to respond to the local outbreaks that will inevitably
arise,” said Kathleen Weber, Executive Vice-President, Business
Unit Leader, Molecular Solutions at DNA Genotek. “Providing labs,
health units and test kit providers with technology like saliva
collection for use at home or supervised by healthcare providers is
critical in the fight against COVID-19. This authorization could be
transformative for public health efforts in Canada and is an
important tool to increase access to testing. As an Ottawa-based
company, we are proud that this is now available to help combat the
pandemic in Canada and we look forward to working with testing
facilities to add our collection kit to their test offerings.”
Self-collected saliva is painless, non-invasive,
and can be accessible to everyone unlike nasopharyngeal swabs which
require supervision by a healthcare provider. Saliva-based
collection is a cornerstone of containing the COVID-19 pandemic, to
help identify cases and prevent new outbreaks from emerging.
In addition to this authorization from Health
Canada, OMNIgene®·ORAL (OME-505) also has
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration and has CE marking for in vitro diagnostic use,
including for use in COVID-19 testing, in the European Union.
About OraSure Technologies
OraSure 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.
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure
Technologies, Inc., focuses on providing high-quality biological
sample collection products and end-to-end services for human
genomics and microbiome applications. The Company's Oragene®•Dx and
ORAcollect®•Dx product lines are the first and only FDA 510(k)
cleared saliva-based DNA collection devices for in vitro diagnostic
use. DNA Genotek also offers Research Use Only products to collect
and preserve large amounts of DNA or RNA from multiple sample
types. DNA Genotek markets its products worldwide and has a global
customer base with thousands of customers in over 100 countries.
For more information about DNA Genotek, visit
www.dnagenotek.com.
Important Information
This 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 |
OraSure Technologies |
212-600-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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