OraSure Wins Contract to Supply “Together Take Me Home,” HIV Self-Testing Initiative Sponsored by the Centers for Disease Control and Prevention
20 Settembre 2022 - 10:05PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that the Company has been selected to
provide its OraQuick® In-Home HIV tests in support of the Centers
for Disease Control and Preventions (CDC) “Together Take Me Home,”
HIV self-test program. Under the program, the CDC will provide
$41.5 million over a five-year period to support community testing.
Emory University will manage the program and closely collaborate
with a number of partner organizations, including OraSure, to
supply tests to communities not equitably reached by HIV testing
services across the United States.
Almost 1.2 million people aged 13 and older have
HIV in the United States, including an estimated 158,500 who don’t
know they have it. Identifying these individuals and linking them
to care is a crucial element of the Ending the HIV Epidemic
initiative and empowers these individuals and their communities to
take control of their healthcare. The “Together Take Me Home”
program helps address testing barriers, including stigma, privacy
concerns, cost, and lack of access to traditional HIV clinics by
offering HIV self-tests through mail delivery. This program follows
a successful collaborative pilot program by the same name, for
which OraSure also supplied tests.
As part of the program, OraSure will provide up
to one million OraQuick® In-Home HIV tests over a five- year
period. Emory University and partner organizations will manage the
program and provide logistical and distribution services for the
tests. A free HIV self-test will be mailed in discreet packages to
people who enroll through its website. The program will target
populations that are disproportionately affected by HIV and less
likely to have access to key prevention services.
“We are proud to work with the Centers for
Disease Control and Emory to help support broader HIV testing and
awareness in underserved communities across the United States,”
said Lisa Nibauer, President of Diagnostics for OraSure
Technologies. “Programs such as the Together Take Me Home
initiative show that the government can take an active role in
making a difference against the major public health crises that we
face as a country and to support marginalized populations. We
firmly believe that these programs reduce the spread of diseases
that disproportionately affect marginalized communities and lower
overall cost to the healthcare system by identifying patients
early, connecting them to care, and allowing for successful
interventions that lead to empowering lives informed by ones HIV
status.”
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.
About OraSure Technologies’ HIV
TestsThe OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is
the first FDA approved, CLIA-waived, rapid point-of care test that
can detect antibodies to both HIV-1 and HIV-2 with greater than 99
percent accuracy in as little as 20 minutes, using an oral fluid,
finger-stick or venipuncture whole blood, or plasma sample. The
OraQuick® In-Home HIV Test is the first and only oral fluid rapid
over-the-counter (OTC) HIV test approved in the U.S. The OraQuick®
In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with
an oral swab, providing a confidential in-home testing option with
results in as little as 20 minutes. It is the first rapid
diagnostic test for any infectious disease that has been approved
by the FDA for sale to the consumer market. The OraQuick® HIV
Self-Test (HIVST) is a rapid, point-of-care test that allows an
individual to detect antibodies to both HIV-1 and HIV-2 with a
simple oral swab and provides a result in as little as 20 minutes
in the privacy of an individual’s home, at outreach testing
settings, in the pharmacy or at community-based screening events.
Based on the same OraQuick® platform that is used for the
FDA-approved OraQuick® In-Home HIV Test and the WHO Prequalified
OraQuick® Rapid HIV-1/2 Antibody Test used by health care
professionals worldwide, the platform has been used to test
millions in international markets.
Important InformationThis press
release contains certain forward-looking statements, including with
respect to the Company’s 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: risk that the Company's exploration of strategic
alternatives may not result in any definitive transaction or
enhance stockholder value and may create a distraction or
uncertainty that may adversely affect operating results, business
or investor perceptions; the diversion of management’s attention
from the Company's ongoing business and regular business
responsibilities due to the Company's exploration of strategic
alternatives; ability to resolve the Company's ongoing
manufacturing challenges and satisfy customer demand; 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 the Company's business and 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; 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, 2021, 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: |
Scott Gleason |
Amy Koch |
SVP Investor Relations & Corporate Communications |
Sr. Mgr. Corporate Communications |
484-425-0588 |
484-523-1815 |
sgleason@orasure.com |
media@orasure.com |
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
Storico
Da Lug 2023 a Lug 2024