OraSure Technologies Receives World Health Organization Prequalification of OraQuick® HIV Self-Test
July 21 2017 - 7:00AM
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 Prequalified by
the World Health Organization (WHO).
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 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, 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. Since the product was first launched,
over 40 million tests have been used by health care professionals
and individuals worldwide.
WHO Prequalification aims to ensure that diagnostic tests for
high burden diseases meet global standards of quality, safety and
efficacy, in order to optimize use of health resources and improve
health outcomes. The Prequalification process entails a rigorous
assessment of a product’s technical performance. Data supporting
the OraQuick HIVST Prequalification demonstrate that the test was
100% sensitive and greater than 99% specific when compared to a
fourth generation laboratory test.
WHO Prequalification is used by United Nations and other
procurement agencies such as PEPFAR, UNITAID and/or the Global Fund
to make purchasing decisions regarding diagnostics, medicines
and/or vaccines. OraSure Technologies also recently entered into an
agreement with the Bill & Melinda Gates Foundation to reduce
the price of the OraQuick HIV Self-Test in 50 developing countries
to accelerate the adoption and deployment of the test.
“We are pleased to offer the first rapid HIV Self-Test to have
received WHO Prequalification,” said Douglas A. Michels, President
and CEO of OraSure Technologies. “WHO Prequalification enables
government organizations implementing HIV Self-Test pilots and
programs to access funding for the OraQuick HIV Self-Test. We
believe this easy-to-use and reliable Self-Test product is a
critical tool for meeting the UNAIDS’s 90/90/90 diagnosis and
treatment targets set for 2020 and will be vital to improving the
health and wellness of those living with HIV on a global scale. The
Prequalification also reaffirms that our HIV Self-Test meets the
stringent technical and quality standards that we place on all of
our products.”
Based on its performance and ease of use, the OraQuick HIV
Self-Test was selected and is being used in the UNITAID/PSI HIV
Self-Testing Africa (STAR) Project. Phase I of the STAR project
aims to improve access to HIV testing through simple HIV self-tests
in three high-burden African countries – Malawi, Zambia and
Zimbabwe, and represents the world’s largest evaluation of HIV
self-testing to date.
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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