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OraSure Technologies Corporate Fact Sheet

Company Overview

OraSure Technologies is empowering the global community to improve health and wellness by providing access to accurate essential information. OraSure is a leader in the development, manufacture and distribution of point-of-care diagnostic tests, molecular 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 Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse. Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome and Novosanis), OraSure provides its customers with value-added, end-to-end solutions that encompass tools, diagnostics and services.

OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research institutions, distributors, government agencies, physicians' offices, commercial and industrial entities, as well as direct to consumers.

Executive Team

  • Stephen S. Tang, Ph.D., President and Chief Executive Officer
  • Roberto Cuca, Chief Financial Officer
  • Kathleen G. Weber, Executive Vice President, Business Unit Leader, Molecular Solutions
  • Anthony Zezzo, Executive Vice President, Business Unit Leader, Infectious Disease
  • Jack E. Jerrett, Senior Vice President, General Counsel and Secretary
  • Mike Reed, Senior Vice President, Research and Development and Chief Science Officer
  • Michele Miller, Vice President,Finance, Controller and Assistant Secretary

Employees

398 (as of 12/31/18)

Molecular Tools & Services

The molecular businesses focus on delivering high-quality products and services in the realms of human genomics, animal genomics and microbiome discovery. The self-collection products are designed to maximize reach and access to samples, enabling academic research, genetic testing and direct-to-consumer applications.

  • The Oragene® family of products is designed for non-invasive DNA self-collection kits to stabilize DNA from saliva. Oragene®•Dx is the first and only FDA 510k-cleared device to collect and stabilize saliva DNA samples with the GenMark Warfarin Assay. It is also cleared for direct-to-consumer testing with the 23andMe product.
  • The OraCollect® family of products is designed for non-invasive DNA self-collection and stabilization kits using a swab oral sample. OraCollect®•Dx is the first and only FDA 510k-cleared sponge-based device to collect and stabilize oral DNA samples with the GenMark Warfarin Assay
  • The OMNIgene® family of products is an all-in-one system for the collection and stabilization of gut, oral, or vaginal microbiome samples.
  • PERFORMAgene and PERFORMAbiome are designed to collect and stabilize genomic and microbial samples from animals.
  • The Colli-Pee™ device, designed by Novosanis, efficiently and hygienically captures a volumetric first-void urine sample.
  • CoreBiome offers microbial profiling of all sample types, including the complete line of DNA Genotek's OMNIgene collection devices, as well as a broad range of high, medium and low microbial biomass sample types. CoreBiome is focused on accelerating discovery for customers in medical, pharmaceutical, agricultural and academic research through advanced sample processing, sequencing and bioinformatics analysis.

Diagnostics & Testing

Infectious Disease

OraSure offers several infectious disease tests based on lateral-flow technology. The ease-of-use and reliability of the products make them ideal for use in clinic and in outreach settings, enabling greater access to high-risk individuals. Rapid testing also enables the patient to receive a result in one interaction, thereby allowing them to be linked to care.

  • OraQuick® HIV family of products includes rapid testing for HIV that provides an answer in as little as 20 minutes. Its ease of use has led to its adoption across the globe as it enables access to patients that may not go to a clinic for testing, and use in low-resource settings. The family of products includes:
    • OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test - the first FDA-approved, CLIA-waived, rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2. For use in professional settings.
    • 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.
    • OraQuick® HIV Self-Test - 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.
  • 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.
  • OraSure QuickFlu® Rapid Flu A+B Test - an FDA-cleared and CLIA-waived in vitro rapid qualitative test for the detection of influenza (flu) type A and type B, including H1N1 viral infections.

Substance Abuse & Insurance Risk Assessment

OraSure offers a range of products that use oral samples for substance abuse testing. The ease-of-use of these products makes them ideal for workplace, criminal justice, drug treatment centers, pain management and clinical setting screening programs.

  • Intercept® Oral Fluid Drug Test - an FDA-cleared laboratory-based oral fluid testing system (Intercept Oral Fluid Collection Device and Intercept Micro-Plate Assays) that enables accurate testing for drugs of abuse, including marijuana, cocaine, PCP, Amphetamines and opiates.
  • Intercept® i2™ Oral Fluid Collection Device - a next generation collection device for drugs of abuse with an adequacy volume indicator.
  • Q.E.D.® Saliva Alcohol Test - a CLIA-waived and U.S. DOT-approved, rapid, low-cost alternative to alcohol breath or blood testing.

Headquarters

220 East First Street
Bethlehem, PA 18015
In the U.S.: 1-800-ORASURE
(1-800-672-7873)

Outside U.S.: (001) 610-882-1820
Fax: (001) 610-882-1825

Stock Symbol

NASDAQ: OSUR

Investor Relations


Phone: 610-882-1820 ext. 3279
E-mail: investorinfo@orasure.com

Web Site

www.OraSure.com

Media Contact

Jeanne Mell
Corporate Communications
Phone: 484-353-1575
E-mail: media@orasure.com

Selected Financial Information

Years Ended
December 31, 2018

 (in thousands, except per share amounts)
(Audited)
2018 2017
Revenues $181,743 $167,064
Net Income $20,396 $30,948
Earnings per share –   Basic
Diluted
$ 0.33
$ 0.33
$ 0.52
$ 0.51
Number of shares – 

Basic
Diluted
61,112
62,532
59,050
61,024