OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in the
fight against HIV, today announced its plans for World AIDS Day.
Commemorated annually on December 1, the U.S. Government's theme
for this year’s World AIDS Day is “Ending the HIV Epidemic:
Equitable Access, Everyone's Voice.” This year also marks 40 years
since the first five cases of what later became known as AIDS were
officially reported.
“When we look back at the past 40 years, we see
a disease that was unfortunately often politicized and placed in a
cultural context, as opposed to being recognized as a critical
public health risk, frequently to the great detriment of the many
affected marginalized communities,” said OraSure President and CEO,
Stephen S. Tang, Ph.D. “However, through multi-stakeholder
collaboration between public and private organizations, great
progress has been made during the past 40 years with regard to
prevention, diagnosis, linkage to care and treatment. OraSure is
proud to be an innovator in the field of HIV, and a global leader
in driving simple point-of-care testing and awareness.”
OraSure was the first company to receive FDA
approval for a professional-use rapid HIV-1/2 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 in many countries internationally, including
sub-Saharan Africa. More than 70 million OraQuick® HIV tests have
been used worldwide in more than 130 countries, helping link those
who test positive to the necessary follow-up resources and care.
The Company also develops diagnostic tests that measure and improve
adherence to PrEP, a medication used by HIV-negative individuals to
prevent HIV seroconversion.
In honor of World AIDS Day, OraSure will ring
the closing bell for the Nasdaq Stock Market on November 30th. The
bell ringing ceremony will be preceded by an expert panel
discussion entitled "The 40-year Story of HIV: Then and Now,” at
Nasdaq Marketsite on Times Square in New York City and will cover
the history of the HIV epidemic, including considerations for
treatment in the time of the COVID-19 pandemic.
The panel discussion will open with remarks from
Harold Phillips, who leads the Office of National AIDS Policy
(ONAP) as part of the U.S. President’s Domestic Policy Council.
Following his remarks, a moderated discussion will be held with
Stephen Lee, M.D., Executive Director of the National Alliance of
State and Territorial AIDS Directors (NASTAD); Vincent
Guilamo-Ramos, Ph.D., member of the U.S. Presidential Advisory
Council on HIV/AIDS and Dean of the School of Nursing and Vice
Chancellor of Nursing Affairs at Duke University; Ingrid Floyd,
Executive Director at Iris House and WORLD; and Marc Meachem, Head
of External Affairs at ViiV Healthcare. The panel will be moderated
by Debra Fraser-Howze, founder of the National Black Leadership
Commission on AIDS and founder of Choose Healthy Life.
In addition to these events in New York, OraSure
employees and customers will take part in HIV testing efforts
around the globe on World AIDS Day. As part of its corporate
philanthropy, the Company also provides sponsorship funds
year-round to more than a dozen non-profit organizations that focus
on ending the HIV epidemic and has provided thousands of free tests
used both domestically and internationally, particularly in
sub-Saharan Africa, to help people know their HIV status.
“The world has been fighting the AIDS epidemic
for 40 years, and we have made progress, but there is still work to
do,” Tang said. “OraSure has a long tradition of tackling our
greatest public health challenges and we believe it’s time to end
the story of HIV and as a Company we stand ready to help make this
vision a reality.”
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.
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.
Important Information
This document 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 of the Company
to manufacture sufficient quantities of the InteliSwab™ COVID-19
rapid test; 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 collection
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 Securities and Exchange Commission (“SEC”) filings, including
our registration statements, Annual Report on Form 10-K for the
year ended December 31, 2020, 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 we undertake no duty to
update these statements.
Investor Contact: |
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Media Contact: |
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Scott
Gleason |
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Amy Koch |
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SVP Investor
Relations & Corporate Communications |
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Sr. Mgr.
Corporate Communications |
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484-425-0588 |
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484-523-1815 |
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sgleason@orasure.com |
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media@orasure.com |
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