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Profile: OraSure Technologies Inc (OSUR.OQ)

OSUR.OQ on NASDAQ Stock Exchange Global Select Market

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OraSure Technologies, Inc. (OraSure), incorporated on May 5, 2000, is involved in the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using its technologies, as well as other diagnostic products, including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company operates in two segments: OSUR and DNAG. OSUR consists of the development, manufacture and sale of diagnostic products, specimen collection devices, and medical devices. DNAG or molecular collection systems business consists primarily of the development, manufacture and sale of oral fluid collection devices that are used to collect, stabilize, and store samples of genetic material for molecular testing. OSUR revenues consist primarily of product sold into the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. OSUR also derives revenues from the sale of over-the-counter (OTC) products to retail pharmacies and mass merchandisers, and to consumers over the Internet and from licensing and product development activities. DNAG revenues consist of product sold into the academic research, consumer genetics, clinical genetic testing, pharmacogenomics, personalized medicine, microbiome and animal genetics markets.

The Company also manufactures and sells medical devices used for the removal of benign skin lesions by cryosurgery or freezing. Its diagnostic products include tests that are performed on a rapid basis at the point of care and tests that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. It sells OTC cryosurgical products to consumers in North America, Europe, Central and South America, and Australia. Its diagnostic product, the OraQuick HCV rapid antibody test, is a hepatitis C virus (HCV) test approved by the United States Food and Drug Administration (FDA) for sale in the United States. In addition, its OraQuick In-Home HIV test is a Human Immunodeficiency Virus (HIV) test approved by the United States Food and Drug Administration for sale in the OTC or consumer retail market in the United States.

OraQuick Rapid HIV Test

The OraQuick is a point-of-care test platform designed to test oral fluid, whole blood (both finger-stick and venous), plasma and serum samples for the presence of various antibodies or analytes. The device uses a porous flat pad to collect an oral fluid specimen. After collection, the pad is inserted into a vial containing a pre-measured amount of developer solution and allowed to develop. This product is sold under the OraQuick ADVANCE name in North America, Europe and certain other countries and under the OraQuick name in other developing countries.

OraQuick In-Home HIV Test

The OraQuick In-Home HIV test is an over-the-counter version of OraQuick ADVANCE HIV 1/2 Antibody Test. The In-Home Test is performed in the same manner as the OraQuick ADVANCE test, except that it has product labeling and instructions designed for consumers.

OraQuick HIV Self-Test

The OraQuick HIV self-test is for use in certain foreign countries. This product has similar diagnostic capabilities as OraQuick In-Home HIV test.

OraQuick HCV Rapid Antibody Test

The OraQuick HCV Rapid Antibody Test is a qualitative test that detects antibodies to the HCV in a range of sample types. The OraQuick HCV test operates in substantially the same manner as the OraQuick HIV tests.

OraQuick Ebola Rapid Antigen Test

The OraQuick Ebola Rapid Antigen Test utilizes the OraQuick technology platform for the detection of Ebola antigen. This test has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration for emergency use by laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection, (including treatment centers and public health clinics) on finger-stick and venous whole blood samples.

OraSure QuickFlu Rapid Flu A&B Test

The OraSure QuickFlu rapid flu A&B test is a qualitative test for the detection of influenza (flu) Types A and B, including H1N1 viral infections. The test utilizes specimen collected with a nasal swab, nasopharyngeal swab or nasal aspirate/wash.

OraSure Collection Device

The OraSure oral fluid collection device is used in conjunction with screening and confirmatory tests for human immunodeficiency 1 (HIV1) antibodies. This device consists of a small, treated cotton-fiber pad on a handle that is placed in a person's mouth for 2 to 5 minutes. The device collects oral mucosal transudate (OMT), a serum-derived fluid that contains higher concentrations of certain antibodies and analytes than saliva.

Tuberculosis Products

The Company's subsidiary, DNA Genotek Inc. (DNAG), offers two infectious disease products targeting tuberculosis (TB). OMNIgene SPUTUM is a non-toxic reagent that liquefies and decontaminates sputum samples at the point-of-collection or in the lab while preserving the viability of TB bacteria for at least eight days at ambient temperatures. This product is being offered to TB laboratories for evaluation. PrepIT MAX is a reagent for extraction of deoxyribonucleic acid (DNA) from TB bacteria. This product is being offered for early stage testing by TB researchers, clinical laboratories, and diagnostic developers who need to extract DNA from TB bacteria for molecular analysis.

Molecular Collection Systems

The Company's subsidiary, DNAG, sells a number of products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA and ribonucleic acid (RNA) from human and animal biologic samples. DNAG's product is sold under the Oragene brand and is used to collect DNA from human saliva. Its OMNIgene GUT product is an all-in-one system designed to enable an individual to self-collect high quality microbial DNA from feces or stool samples for gut microbiome profiling for use in clinical laboratory and research use settings. Its molecular business also offers customers its GenoFIND services, a suite of genomic and microbiome services that range from package customization and study design optimization to extraction, analysis and reporting services.

Intercept Drug Testing System

A collection device that is substantially similar to the OraSure device is sold by the Company under the name Intercept, and is used to collect OMT for oral fluid drug testing. Its Intercept device and oral fluid assays are sold in the United States primarily through laboratory distributors.

Cryosurgical Systems (Skin Lesion Removal Products)

The Histofreezer cryosurgical removal system is an alternative to liquid nitrogen and other methods for removal of warts and other benign skin lesions by physicians. The Histofreezer product mixes three cryogenic gases in a small aerosol canister. When released, these gases are delivered to a specially designed foam bud, cooling the bud to a maximum of -50-degree Celsius to -55-degree Celsius. The frozen bud is then applied to the wart or lesion for 15 to 40 seconds (depending on the type of lesion) creating localized destruction of the target area by freezing. Internationally, the Company sells an OTC cryosurgical product through its distributor Genomma Labs (Genomma), under the POINTTS name, in Mexico and a number of South and Central American countries.

Immunoassay Tests and Reagents

The Company develops and sells immunoassay tests in formats, known as MICRO-PLATE and AUTO-LYTE. In a MICRO-PLATE kit, the sample to be tested is placed into a small plastic receptacle, called a microwell, along with the reagents. The result of the test is determined by the color of the microwell upon completion of the reaction. MICRO-PLATE tests are performed on instruments and detect drugs in urine, serum and sweat specimens. MICRO-PLATE tests are used as part of the Intercept product line to detect drugs-of-abuse in oral fluid specimens. AUTO-LYTE tests are sold in the form of bottles of liquid reagents. These reagents run on available laboratory-based automated analytical instruments, which are manufactured by a range of third parties. AUTO-LYTE is used in high volume, automated, commercial reference insurance laboratories to detect certain drugs or chemicals in urine.

Western blot HIV-1 Confirmatory Test

The Company sells an oral fluid Western blot Human Immunodeficiency Virus Type 1 (HIV-1) confirmatory test. This test uses the original specimen collected with the OraSure oral fluid collection device to confirm positive results of initial oral fluid HIV-1 enzyme immunoassay (EIA) screening tests.

Q.E.D. Saliva Alcohol Test

The Q.E.D. saliva alcohol test is a point-of-care test device that is an alternative to breath or blood alcohol testing. The test is a quantitative, saliva-based method for the detection of ethanol. Each Q.E.D. test kit contains a collection stick that is used to collect a sample of saliva and a disposable detection device that displays results in a format similar to a thermometer.

Company Address

OraSure Technologies Inc

150 WEBSTER ST
BETHLEHEM   PA   18015
P: +1503.6416115
F: +1610.8821830

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