OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in the
fight against HIV, will ring the closing bell for the Nasdaq Stock
Market this afternoon in honor of World AIDS Day. World AIDS Day is
commemorated annually on December 1 to raise awareness of the AIDS
epidemic and to mourn the loss of those who have died of the
disease. The U.S. Government's theme for this year’s World AIDS Day
is “Putting Ourselves to the Test: Achieving Equity to End HIV,” to
emphasize the importance of uplifting marginalized and vulnerable
groups who bear the brunt of the burden of HIV in the
country.
“OraSure has played a critical role in the fight
against HIV globally since 2002. For more than two decades, we have
championed the importance of access to personal information about
health through easy-to-use diagnostics, particularly for vulnerable
communities around the world most burdened by HIV,” said OraSure
President and CEO Carrie Eglinton Manner. “Today we vow to continue
that fight, both globally through partnership with non-governmental
organizations that provide tests to low- and middle-income
countries to help combat the HIV crisis, and domestically through
innovative programs like the Centers for Disease Control and
Preventions (CDC) ‘Take Me Home,’ HIV self-test
program.”
Under the CDC program, OraSure may supply up to
one million OraQuick® In-Home HIV tests to engage individuals who
are disproportionately affected by HIV and less likely to have
access to key diagnostic, prevention, and treatment services across
the United States.
Almost 1.2 million people aged 13 and older have
HIV in the United States, including an estimate of nearly 160,000,
who currently do not know that they are infected. Identifying these
individuals and linking them to care is a crucial priority for
eradicating HIV. With pre-exposure prophylaxis (PrEP), a medication
used by HIV-negative individuals to prevent HIV seroconversion,
people can take control of their health and prevent infection
before it starts. For people living with HIV, effective treatment
allows them to enjoy long and healthy lives and, with an
undetectable viral load, means that they cannot transmit HIV
through sex. This is commonly known as U=U, or “undetectable equals
untransmittable.”
OraSure was the first company to receive FDA
approval for a professional-use rapid HIV-1 test in 2002 with its
OraQuick® Rapid HIV-1 Antibody Test. In 2012, the Company received
FDA approval for the first, and still only, over-the-counter oral
fluid HIV test, the OraQuick® In-Home HIV Test. In 2017, the
Company received World Health Organization (WHO) prequalification
for the OraQuick® HIV Self-Test, which is sold for use by
individuals internationally, including significant use in
sub-Saharan Africa which has the highest rates of HIV globally.
More than 90 million OraQuick® HIV tests have been used worldwide
in more than 130 countries, helping link those who test positive to
appropriate confirmation testing and care. The Company is also
developing new diagnostic tests to support clinicians in improving
adherence to PrEP, ensuring that the medication is used
consistently so that high-risk individuals without HIV remain free
of infection.
In addition to the Nasdaq closing bell ceremony,
OraSure employees will also meet with key opinion leaders and those
who help represent and serve marginalized communities most burdened
by HIV and will support awareness, testing and treatment
initiatives around the globe.
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:Scott GleasonSVP Investor Relations & Corporate
Communications Communications484-425-0588sgleason@orasure.com |
Media
Contact:Amy KochSr. Mgr. Corporate
Communications484-523-1815media@orasure.com |
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