OraSure Technologies and its subsidiaries, pioneer new paths to empower the global community to improve the health and wellness through biological sampling, services, and diagnostics. By providing access to accurate, essential personal health information, our products help people understand, in broad terms, what is in us, what is on us and what is around us.
Diagnostic solutions: We are committed to solving the world’s most complex testing challenges. Our legacy of innovation includes first-to-market rapid diagnostics for HIV, Hepatitis C and Ebola that link people to life-saving care.
Sampling solutions: We develop easy-to-use and reliable biological sample collection and stabilization devices. Our products maximize sample quality to ensure the highest integrity, from initial collection through downstream analysis for molecular applications. Our sampling subsidiaries include DNA Genotek and Novosanis.
Services & Analysis solutions: We accelerate the molecular industry toward breakthrough discoveries through our innovative and accurate lab services, augmented by state-of-the-art data analytics and reporting. Our services subsidiaries include CoreBiome and Diversigen.
OraSure Technologies was founded in 1987 from Ben Franklin Technology Partners of Northeastern PA Business Incubator at Lehigh University. Through acquisitions, innovation and organic growth we have become the organization we are today. With headquarters in Bethlehem, PA, we have subsidiaries in Europe, Canada and throughout the United States.
OraSure provides its customers with value-added, end-to-end solutions that encompass sampling tools, services and diagnostics. Our portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research institutions, government agencies, physicians’ offices, commercial and industrial entities, as well as direct-to-consumers.
OraSure has a legacy of innovation in solving complex diagnostic challenges. The Diagnostics solutions area of our business has been focused on the development of rapid, point-of-care testing devices for critical diseases such as HIV, HCV and Ebola.
In 2004 the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test became the first FDA-approved, CLIA-waived, rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 with oral samples and is designed for use in professional settings.
In 2010 we introduced our OraQuick® HCV Rapid Antibody Test, the first FDA-approved, CLIA-waived rapid HCV test. In Europe, it is the only CE-marked approved, point-of-care device that works on oral fluid, whole blood, serum and plasma for HCV. OraQuick HCV is approved for the detection of HCV antibodies for individuals with signs and symptoms or at risk of infection.
In 2012 we launched our OraQuick® In-Home HIV Test: the first and only oral fluid rapid over-the-counter HIV test approved in the U.S. For self-test use; available online and through retail outlets.
In 2017 the OraQuick® HIV Self-Test was the first and only oral fluid rapid test pre-qualified by the World Health Organization. For use in global settings to enable elimination programs and self-testing.
In 2019 we were granted approval for the OraQuick® Ebola Rapid Antigen Test as the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD).
The following diagram illustrates some of our major milestones.
Self Testing Products
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.
OraQuick® HIV Self-Test platform was the first to receive World Health Organization Prequalification in July 2017. They are designed for accuracy and ease-of-use which makes them ideal for use in low-resource settings or outreach testing programs. 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 healthcare professionals 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. The OraQuick HIV -1/2 Antibody Test has been evaluated in hundreds of peer reviewed journal publications. 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.
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. A total of 4.8 million HIV self-test kits will be distributed across Malawi, Zambia, Zimbabwe, South Africa, Lesotho, and Swaziland by 2020, representing the world’s largest evaluation of HIV self-testing to date.
OraSure is also participating with global health partners, as part of the Rome Action Plan for Paediatric HIV, to enhance pediatric diagnostic testing. Recently, OraSure received WHO change notifications for the WHO Pre Qualified OraQuick HIV 1 / 2 Rapid Test and the OraQuick HIV Self Test. These changes will allow doctors in professional settings to test children two years of age and older, and for parents and guardians to test their children. This will allow for broader use of these tests in hard to reach pediatric populations. Data to support the validation of the age reduction was provided through collaboration with the Biomedical Research and Training Institute B-GAP study in Zimbabwe and the University of Washington STEP-UP study in Kenya.
In June of 2017, OraSure Technologies entered into an agreement with Bill & Melinda Gates Foundation to reduce the price of the OraQuick® rapid, point-of-care HIV self-test in 50 low- and middle-income countries. The agreement is designed to enable OraSure to offer its OraQuick® HIV Self-Test at an affordable price in 50 priority countries with funding from the Gates Foundation. 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. This initiative supports the rapid scale-up and adoption of the OraQuick® HIV Self-Test in the fight against HIV/AIDS. 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 substantially accelerate the adoption of the OraQuick® HIV Self-Test in many more developing countries.
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. OraSure also works with government and non-government organizations and advocacy groups globally to support innovative programs to add self-testing to their HIV initiatives to find and diagnose the previously untested to link them to critical care and save lives. Our products are available through community testing, at pharmacies, in retail and online.
Our mission to do good and help solve the world’s greatest health challenges is what drives us. We are committed to making a difference in the world of individual and public health by enabling access to discovery and diagnostics such as HIV Self Tests. As the first WHO-prequalified HIV self-test, we are leading the way in self-testing. We believe that it is imperative that the global arena has access to effective, reliable and easy-to-use HIV testing products. Our rapid testing platforms bring testing out into the communities and rural settings that need care but have a challenge accessing centralized testing methods offered through clinics and hospitals.
Phase I of the STAR Project 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 future testing. Phase II of the Project, which is nearing completion, aims to demonstrate population-level health impact of HIVST over a two-year period.
The findings from the STAR Project demonstrate the significant impact that self-testing provides in diagnosing and treating individuals infected with HIV in even the most remote geographies. It is estimated that 81% of people with HIV in sub-Saharan Africa are now aware of their status. That’s up from 45% in 2014 before the initiative began. We believe that easy-to-use and reliable self-testing options are critical to meet the UNAIDS’s 90/90/90 treatment targets set for 2030 and are vital to improving the health and wellness of those living with HIV on a global scale.
With the support of the Gates Foundation subsidy and the growing number of countries who are adopting their own programs, we are proud to be used on a growing scale across the globe. Our sales and marketing teams also frequently support our customers by volunteering at testing events across the globe. We hope to continue to play a significant role in global testing programs. We are seeing more countries adopt HIV Self Testing and start programs to scale testing. We are working with Ministries of Health, implementers and funders to develop materials to support training of testers and end-users while working with program sponsors to provide the toolkits needed to get these programs off the ground. We believe that HIV Self-Testing will continue to play a critical role in reaching those people who are not connected to health services and linking them to diagnosis and treatment.
OraSure is continuously seeking ways to increase the ease-of-use and impact of our products by either adding new claims or by improving the user instructions and support materials used by testers, pharmacists and others who are implementing testing programs.
We are excited to make the OraQuick® HIV Self-Test available in Nigeria. OraSure was pleased to announce the approval of the OraQuick HIV Self Test with the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria on 4 September 2019. The OraQuick® HIV Self Test registration number is: 03-7073.
With this approval, we are aligning ourselves with the mission of NAFDAC, which is to safeguard public health by ensuring that only the right quality medical devices are manufactured, imported, distributed, advertised, sold and used in Nigeria.
We believe the easy-to-use and reliable OraQuick® HIV Self-Test is vital to improving the health and wellness of those living with HIV in Nigeria. The approval reaffirms that the OraQuick HIV Self-Test meets the stringent technical and quality standards that we place on all of our products.
The NAFDAC approval follows soon after completion of an evaluation of the OraQuick® HIV Self- Test by the Ministry of Health in which the product proved to be very accurate and found to be Easy, Safe, Acceptable and Empowering.
The OraQuick® HIV Self Test remains the only oral-based HIV Self-Test that is approved by NAFDAC and has achieved pre-qualification by the World Health Organization (WHO).
The above-mentioned regulatory approvals, together with a Charitable Support Agreement between OraSure Technologies Inc. and the Bill & Melinda Gates Foundation enables OraSure Technologies to offer the OraQuick® HIV Self-Test at an affordable price in Nigeria.
We will be working closely with the Ministry of Health and test program implementers to facilitate scale up and awareness building surrounding HIV prevention and HIV testing.