OraSure’s OMNIgene®·ORAL Collection Device Receives FDA Emergency Use Authorization for SARS CoV-2
October 19 2020 - 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
DNA Genotek subsidiary has received Emergency Use Authorization
(EUA) from the U.S. Food and Drug Administration (FDA) for the use
of DNA Genotek’s OMNIgene®·ORAL (OM-505, OME-505) saliva collection
and stabilization device in COVID-19 testing. This is the first FDA
EUA that allows for the unsupervised use of the device at-home or
in a healthcare setting when used as part of an approved or
validated at-home test kit, meaning patients can safely collect
their own sample, without the presence of a healthcare
professional.
With this FDA authorization, OMNIgene®·ORAL devices can be used
for the self-collection, transport and laboratory testing of saliva
specimens suspected of containing SARS-CoV-2 ribonucleic acid
(RNA). This EUA follows the CE marking of OMNIgene®·ORAL (OME-505)
for in vitro diagnostic use, including for COVID-19 testing, in the
European Union.
“Since the beginning of the pandemic, DNA Genotek has been
committed to addressing this global health emergency, and we are
pleased to be able to provide a robust solution for easy, safe
sample collection that supports detection of this highly contagious
virus,” said Kathleen Weber, Executive Vice President, Business
Unit Leader, Molecular Solutions at DNA Genotek. “Laboratories and
test providers in both the U.S. and European Union can benefit from
having a device that collects RNA for SARS-CoV-2, as evidenced by
it being both CE marked and FDA authorized.”
“Easy-to-use and reliable methods to detect SARS-CoV-2 are
crucial to meet the massive need for testing which the Rockefeller
Foundation estimates at 2.4 billion tests annually in the U.S.
alone,” said Stephen S. Tang, Ph.D., OraSure President and Chief
Executive Officer. “The DNA Genotek team quickly leveraged its
innovative spirit and expertise with molecular sample collection to
address this need with OMNIgene®·ORAL and the unsupervised, in-home
sample collection that it supports when used as part of a validated
at-home test kit.”
In addition to its device EUA, OraSure announced several other
milestones related to the use of DNA Genotek’s collection devices
for COVID-19 testing:
- Use of DNA Genotek collection kits continue to grow in
back-to-work settings, back-to-school programs, and laboratory
testing, including:
- 30,000 students tested at the University of Kansas before
returning to campus, via Clinical Reference Laboratory;
- 64 State University of New York campuses testing students and
employees, via Quadrant Biosciences;
- Test kits available at Albertsons Companies pharmacies
throughout the U.S. via Phosphorus Diagnostics;
- Back-to-work programs integrating COVID-19
testing, monitoring, assessment and access to telemedicine
visits for companies, through Azova, Inc.
- DNA Genotek has scaled up manufacturing of saliva collection
devices to meet customer demand for COVID-19 testing, and plans to
significantly increase capacity in the first quarter of 2021.
- The DNA Genotek kits for detection of the SARS-CoV-2 virus have
been included in six customer EUAs. The OMNIgene®·ORAL device has
been included in EUAs granted to Clinical Reference Laboratory
(CRL) and P23. The OraCollect®·RNA device has been included in EUAs
granted to Biocerna LLC, MiraDx and Quadrant Biosciences. The
Oragene®·Dx device has been included in an EUA granted to
Phosphorus Diagnostics.
- DNA Genotek’s devices support both PCR and sequencing-based
COVID-19 tests, and its collection kits can be used for collection
at home by consumers or by laboratory staff and healthcare
providers.
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.
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 June 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 |
212-602-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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