OraQuick® HIV Self-Test Selected for Next Phase of STAR Project for HIV Self-Testing in Africa
24 July 2017 - 9:51PM
OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care
diagnostic tests and specimen collection devices, today announced
that its OraQuick® HIV Self-Test (HIVST) has been selected by
UNITAID and Population Services International (PSI) for use in
Phase II of the HIV Self-Testing Africa (STAR) Project.
The STAR Project Phase II, beginning in Q4 of
2017, will deploy HIV Self-Testing in Malawi, Zambia, Zimbabwe,
South Africa and additional African countries to demonstrate the
population-level health impact of HIVST over a two-year period. The
vast majority of the 4 million tests used in Phase II are expected
to be the OraQuick® HIV Self-Test.
The OraQuick® HIV Self-Test has been used in
Phase I of the STAR Project, which represented the largest
evaluation of HIV self-testing to date. The study distributed
750,000 OraQuick® HIV Self-Tests throughout Malawi, Zambia and
Zimbabwe between 2015 and 2017. Phase I successfully demonstrated
how self-testing with OraQuick® HIVST can increase the number of
people who are tested and know their HIV status. The project also
provided best practices for implementation, uptake and self-test
delivery models to inform Phase II scale-up.
“It is estimated that less than 50% of adults
living with HIV know their status; this is particularly true for
high-burden countries,” said Dr. Karin Hatzold, Project Director of
the UNITAID/PSI STAR Project. “Through our joint project with
UNITAID, we can promote self-testing to better reach people with
limited access to current HIV testing services due to privacy
issues or lack of convenience. It can also encourage re-testing
among those at high risk.”
“The findings from Phase I of the study
demonstrate the significant impact that self-testing provides in
diagnosing and treating individuals infected with HIV in even the
most remote geographies. We are delighted to be selected for Phase
II of the initiative and believe that easy-to-use and reliable
self-testing options are critical to meet the UNAIDS’s 90/90/90
treatment targets set for 2020 and are vital to improving the
health and wellness of those living with HIV on a global scale”
said Douglas A. Michels, President and CEO of OraSure
Technologies.
For more information on the STAR Project please
reference the UNITAID press release
https://unitaid.eu/news-blog/worlds-largest-hiv-self-testing-initiative-expands-critical-new-phase.
About the OraQuick® HIV
Self-Test
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. The product is 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.
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 healthcare providers to deliver critical
information to patients, 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.
Ronald H. Spair
Chief Financial Officer
610-882-1820
investorinfo@orasure.com
Shauna White
Corporate Marketing Manager
484-353-1575
media@orasure.com
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