OraSure Technologies to Drive Accelerated Adoption of OraQuick® HIV Self-Test

OraSure Technologies enters agreement with Bill & Melinda Gates Foundation to reduce price of rapid, point-of-care HIV self-test in 50 developing countries

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| Source: OraSure Technologies

BETHLEHEM, Pa., June 27, 2017 (GLOBE NEWSWIRE) -- 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