OraSure’s DNA Genotek Subsidiary Receives FDA Emergency Use Authorization for its ORAcollect®·RNA Saliva Collection Devic...
November 03 2020 - 7:00AM
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 the ORAcollect®·RNA (OR/ORE-100) saliva collection device for
the collection, stabilization and transport of saliva specimens
suspected of containing SARS-CoV-2 RNA. This is the second FDA EUA
that DNA Genotek has received for its saliva collection devices.
Like the EUA DNA Genotek recently obtained for
OMNIgene®·ORAL (OM/OME-505), this EUA allows for the unsupervised
use of the device at-home or in a healthcare setting when used as a
component of an authorized or cleared self-collection kit. This
means it can be part of a kit that is authorized under its own EUA
for use by an individual to collect saliva specimens at home.
“Accessible and accurate testing programs that
include a non-invasive, saliva-based collection option will be
essential throughout the duration of the COVID-19 pandemic,” said
Kathleen Weber, Executive Vice President, Business Unit Leader,
Molecular Solutions at DNA Genotek. “This second EUA gives our
customers additional non-invasive options for SARS CoV-2 sample
collection. Saliva sample collection is quick, painless,
non-invasive and requires less human contact both minimizing the
need for PPE and reducing exposure to potentially infected
patients.”
The ORAcollect·RNA collection device is an
important component of molecular/PCR tests as laboratories are able
to use it as the saliva sample collection method for their COVID-19
tests.
In addition to molecular sample collection
devices for lab-based molecular/PCR COVID-19 testing from its DNA
Genotek subsidiary, OraSure is also developing a lab-based oral
fluid SARS-CoV-2 antibody test, and a rapid antigen self-test for
COVID-19.
The ORAcollect·RNA and OMNIgene·ORAL sample
collection devices have not been FDA cleared or approved; the
devices have been authorized by FDA under an EUA. The
ORAcollect·RNA and OMNIgene·ORAL sample collection devices have
been authorized only to collect, stabilize, and maintain during
transport, saliva specimens suspected of containing SARS-CoV-2
ribonucleic acid (RNA), not for any other viruses or pathogens; and
the ORAcollect·RNA and OMNIgene·ORAL sample collection devices are
only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of in medical devices during the COVID-19 outbreak under
Section564(b)(1) of the Federal Food, Drug, and Cosmetic
Act,21U.S.C. §360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
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 GenotekDNA 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 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 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: |
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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