OraSure Technologies to Drive Accelerated Adoption of OraQuick® HIV Self-Test
2017年6月27日 - 7:00PM
OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care
diagnostic tests and specimen collection devices, today announced a
new agreement with the Bill & Melinda Gates Foundation that
will enable OraSure to offer its OraQuick® HIV Self-Test at an
affordable price in 50 developing countries with funding from the
Gates Foundation. The funding will consist of support
payments tied to the volume of product sold by OraSure and
reimbursement of certain related costs.
Under a four-year Charitable Support Agreement,
OraSure will make its OraQuick® HIV Self-Test available for
purchase in 50 developing countries located in Africa and Asia.
These countries include Malawi, Zambia and Zimbabwe, where the
Company has been providing tests for the “Self-Testing in Africa”
or “STAR” Project implemented by Population Services International
(“PSI”).
Through this agreement, funding from the Gates
Foundation will enable non-governmental organizations in eligible
countries that receive funding from government or public sector
agencies and donors such as the Children’s Investment Fund
Foundation (UK), the Global Fund, PEPFAR and UNITAID to access HIV
self-testing at reduced pricing. The funding from the Gates
Foundation will be in an aggregate amount not to exceed $20 million
over the four-year term or $6 million each year of the
agreement.
“We are pleased to work with the Bill &
Melinda Gates Foundation on this important initiative designed to
support the rapid scale-up and adoption of the OraQuick® HIV
Self-Test in the fight against HIV/AIDS,” said Douglas A. Michels,
President and CEO of OraSure Technologies. “We are witnessing
the benefits of HIV self testing through the use of our product by
PSI under the STAR Project. The support payments provided by
the Gates Foundation will help us expand our relationship with PSI
and substantially accelerate the adoption of the OraQuick® HIV
Self-Test in many more developing countries.”
“Diagnosing HIV quickly and accurately is
critical to both improving treatment access and preventing new
infections,” said Emilio Emini, Director of the HIV program at the
Bill & Melinda Gates Foundation. “This initiative will allow
for increased access to self-conducted HIV screening, resulting in
a substantially improved ability to recognize and treat individuals
living with HIV.”
The Gates Foundation is making this investment
as part of its program-related investments (PRI) strategy, which
aims to stimulate private sector-driven innovation, encourage
market-driven efficiencies and attract external capital to priority
global health and development initiatives that improve the lives of
the world’s most vulnerable people.
The OraQuick® HIV Self-Test is a rapid,
point-of-care test that allows an individual to detect antibodies
to both HIV-1 and HIV-2 with an oral swab, with results in as
little as 20 minutes. It is the same test used in the
Company’s OraQuick® In-Home HIV Test, the first and only
FDA-approved in-home HIV test for consumers, except that the
packaging and product instructions have been tailored for use by
individuals in developing countries.
About OraSure
Technologies
OraSure Technologies is a leader in the
development, manufacture and distribution of point-of-care
diagnostic and collection devices and other technologies designed
to detect or diagnose critical medical conditions. Its
first-to-market, innovative products include rapid tests for the
detection of antibodies to HIV and HCV on the OraQuick® platform,
oral fluid sample collection, stabilization and preparation
products for molecular diagnostic applications, and oral fluid
laboratory tests for detecting various drugs of abuse. OraSure's
portfolio of products is sold globally to various clinical
laboratories, hospitals, clinics, community-based organizations and
other public health organizations, research and academic
institutions, distributors, government agencies, physicians'
offices, commercial and industrial entities and consumers. The
Company's products enable individuals to obtain critical health
information at the point-of-care, thereby empowering them to make
decisions to improve and protect their health.
For more information on OraSure Technologies,
please visit www.orasure.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 market
and sell products, whether through our internal, direct sales force
or third parties; 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 FDA or other regulators; 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; impact of increased reliance on U.S. government
contracts; failure of distributors or other customers to meet
purchase forecasts, historic purchase levels or minimum purchase
requirements for our 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; impact of
negative economic conditions, high unemployment levels and poor
credit conditions; 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 testing or
other products; 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; history of
losses and ability to achieve 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 meet
financial covenants in credit agreements; 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 are discussed more fully
in the Company’s Securities and Exchange Commission (“SEC”)
filings, including our registration statements, Annual Report on
Form 10-K for the year ended December 31, 2016, 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. The forward-looking statements are
made as of the date of this press release and OraSure Technologies
undertakes no duty to update these statements.
Company contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
Shauna White
Corporate Marketing Manager
484-353-1575
media@orasure.com
www.orasure.com
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