Company Overview

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration for the Company's OraQuick® In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market – making it the first and only rapid OTC HIV test approved in the U.S.

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, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.  

DNA Genotek
Based in Ottawa, Canada, DNA Genotek focuses on providing high-quality biological sample collection, stabilization and preparation products. The company's lead product, the Oragene®•DNA Self-Collection Kit, is the easiest way to collect and preserve large amounts of DNA from saliva.

Executive Team

• Douglas A. Michels, President and Chief Executive Officer
• Ronald H. Spair, Chief Operating Officer and Chief Financial Officer
• Stephen R. Lee, Executive Vice President and Chief Science Officer
• P. Michael Formica, Executive Vice President and General Manager, Cryosurgery
• Anthony Zezzo, Executive Vice President Sales and Marketing
• Jack E. Jerrett, Senior Vice President, General Counsel and Secretary
• Mark L. Kuna, Senior Vice President, Finance, Controller and Assistant Secretary
• Henry B. Cohen, Senior Vice President, Human Resources
• Ian Curry, President, DNA Genotek, Inc.
• Debra Y. Fraser-Howze, Senior Vice President, Government and External Affairs
• Nancy McLane, Senior Vice President, Operations
• Jill Thompson, Senior Vice President, Business Development
• Ron Ticho, Senior Vice President, Corporate Communications
• Kathleen Weber, Senior Vice President and General Manager, Consumer Products

Clients

OraSure Technologies' client base includes hospitals, public health agencies, physicians' offices, clinical laboratories, workplace sites, insurance companies and criminal justice facilities in the United States and abroad.

Employees

330

OraSure Technologies develops, manufactures and markets point-of-care, oral fluid specimen collection devices that leverage proprietary oral fluid technologies, diagnostic products, including immunoassays and other in vitro diagnostic tests, and other medical devices.

These products include tests for the detection of antibodies for the HIV virus, including the OraQuick® In-Home HIV Test, OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test and the OraSure® HIV-1 Oral Specimen Collection Device, a test for the HCV virus, the OraQuick® HCV Rapid Antibody Test, and oral fluid testing solutions for drugs of abuse testing, including Intercept® Oral Fluid Drug Testing System and Q.E.D.® Saliva Alcohol Test. The Company also manufactures and sells several leading products for the cryosurgical removal of common and plantar warts and several other benign skin lesions.

Infectious Disease

• OraQuick® In-Home HIV Test – the first and only oral fluid rapid OTC HIV test approved in the U.S. The OraQuick® In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. It is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale over the counter.
• OraQuick® HCV Rapid Antibody Test – the first and only FDA-approved rapid HCV test in the U.S. OraQuick HCV is approved for the detection of HCV antibodies in venous whole blood specimens for individuals at risk. The test received the CE Mark for use with oral fluid, whole blood, serum and plasma for HCV.
• OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test – the first and only FDA approved, CLIA-waived, rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 with greater than 99% accuracy in as little as 20 minutes, using an oral fluid, fingerstick or venipuncture whole blood, or plasma sample.
• OraSure® HIV-1 Oral Specimen Collection Device – the only FDA approved, laboratory-based collection device that collects oral fluid to test for antibodies to the HIV-1 virus.

Substance Abuse

• Intercept® Oral Fluid Drug Testing System – an FDA-cleared oral fluid drugs of abuse test that provides a smart alternative to costly, inconvenient and often embarrassing urine drug testing. This testing service detects the "NIDA-5" drug panel (marijuana, cocaine, opiates, PCP and amphetamines) plus barbiturates, methadone and benzodiazepines without the need to collect urine.
• Q.E.D.® Saliva Alcohol Test – an FDA-cleared on-site, low-cost alternative to breath or blood testing for alcohol. The test is easy to administer and provides quantitative results as accurate as a blood test.

Cryosurgical Treatment

• Histofreezer® Portable Cryosurgical System - an FDA-cleared, low-cost, highly effective portable cryosurgical system for medical professional use for the treatment of common warts and benign skin lesions.
• Freeze 'n Clear Skin Clinic™ Advanced Wart Remover – an FDA-cleared, cryosurgical wart treatment product sold over-the-counter in the United States for the treatment of common and plantar warts.
• Scholl Freeze Verruca & Wart Remover – cryosurgical wart treatment product sold over-the-counter in Europe for the treatment of common and plantar warts; manufactured by OraSure and distributed by SSL International plc under the Scholl and Dr. Scholl trademarks.
• Pointts® Wart Remover – cryosurgical wart treatment product sold over-the-counter in Central and Latin America for the treatment of common and plantar warts; manufactured by OraSure and distributed by Genomma Lab® Internacional.

Selected Financial Information