Press Release

OraSure Receives Global Fund Classification to Enable HIV Self-Test Procurement

BETHLEHEM, Pa., March 01, 2017 (GLOBE NEWSWIRE) -- 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 has been designated as eligible for procurement by purchasing entities entitled to access Global Fund and/or UNITAID resources. 

The OraQuick® HIV Self-Test has been classified by the Global Fund’s Expert Review Panel for Diagnostics as CATEGORY-2. The classification facilitates product procurement for 12 months with Global Fund and/or UNITAID resources. During this period, OraSure is expected to pursue and obtain WHO (World Health Organization) pre-qualification of the product or approval from another stringent regulatory agency. 

“We are pleased to have received the endorsement of the Global Fund’s Expert Panel,” said Douglas A. Michels, President and CEO of OraSure Technologies. “The classification enables government organizations implementing HIV self-test pilots and programs to access funding for the OraQuick® HIV Self-Test.  We expect the OraQuick® HIV Self-Test to be a valuable tool in reducing HIV infection rates globally.  The Global Fund’s action allows for the procurement of our test while we pursue WHO prequalification.”  

About the Global Fund and UNITAID

The Global Fund is a partnership between governments, civil society, the private sector and people affected by diseases. The partnership organization is designed to finance programs aimed at accelerating the end of HIV/AIDS, tuberculosis and malaria as epidemics. For more information, please visit

UNITAID is engaged in finding new ways to prevent, treat and diagnose HIV/AIDS, tuberculosis and malaria. UNITAID identifies promising health solutions and invests in them to establish their viability in support of widespread adoption and impact. For more information, please visit

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

Company contact:

Ronald H. Spair
Chief Financial Officer

Media contact:

Shauna White
Corporate Marketing Manager

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OraSure Technologies

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