Profile: OraSure Technologies Inc (OSUR.O)

OraSure Technologies, Inc., incorporated on May 5, 2000, is engaged in development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using the Company's oral fluid technologies, as well as other diagnostic products, including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company also manufactures and sells medical devices used for the removal of benign skin lesions by cryosurgery or freezing. The Company's diagnostic products include tests that are performed on a rapid basis at the point of care and tests that are processed in a laboratory. On August 17, 2011, the Company completed the acquisition of DNA Genotek Inc. (DNAG).

The Company operates in two segments: OraSure business and DNAG. The OraSure business consists of the development, manufacture and sale of oral fluid diagnostic products and specimen collection devices and the manufacture and sale of medical devices used for the removal of benign skin lesions by cryosurgery. The DNAG segment is based in Ottawa, Canada and manufactures and sells oral fluid collection devices that are used to collect samples of genetic material for molecular testing. OraSure revenues consist primarily of product sold into the United States and internationally to various clinical laboratories, hospital, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. DNAG revenues consist of product sold into the Unites States and internationally in the academic research, clinical genetic testing, pharmacogenomics, personalized medicine, animal and livestock genetics markets.

The Company’s principal products include OraQuick ADVANCE HIV-1/2, OraQuick HIV-1/2 OTC, OraQuick HCV, OraSure QuickFlu Rapid Flu A&B Test, OraSure,, Intercept, MICRO-PLATE DOA Assays, Homogeneous DOA Assays, Cryosurgical Systems- Professional, Cryosurgical Systems-OTC, Oragene DX, Oragene DNA, Oragene DISCOVER, Oragene RNA, ORAcollect, OMNIgene DISCOVER, Performagenen LIVESTOCK and Oragene ANIMAL. In addition to the Company also sells certain immunoassay tests and reagents for insurance risk assessment, substance abuse testing and forensic toxicology applications; an oral fluid Western blot HIV-1 confirmatory test for confirming positive human immunodeficiency virus (HIV)-1 test results obtained from the use of its OraSure collection device, and the Food and Drug Administration (FDA) 510(k) cleared Q.E.D. rapid point-of-care saliva alcohol test.

Diagnostic 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. One of the Company's products is sold in the over-the-counter (OTC) or consumer retail markets in North America, Europe, Central and South America, and Australia. During the year ended December 31, 2011, its research and development activities focused primarily on clinical and regulatory activities related to obtaining a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its OraQuick HCV test, completing the final phase of clinical testing and preparing and filing a PMA application for FDA approval of an OraQuick HIV OTC test, development of next generation versions of its OraQuick HIV and Intercept products and assessing initial feasibility of certain other products.

OraQuick Rapid HIV Test

The Company’s OraQuick is a rapid point-of-care test platform designed to test oral fluid, whole blood, plasma and serum samples for the presence of various antibodies or analytes. The OraQuick device is a screening test and generally requires a confirmation test where an initial positive result is obtained. 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. The test has received PMA approval from the FDA for the detection of antibodies to both HIV-1 and HIV-2 in oral fluid, finger-stick whole blood, venous whole blood and plasma. This test is available for use by laboratories located in the United States certified under the CLIA, to perform moderately complex tests.

OraQuick HCV Rapid Antibody Test

Another test available on the OraQuick platform is the OraQuick HCV rapid antibody test. Like the OraQuick HIV test, this product can detect antibodies to the Hepatitis C virus (HCV), in a variety of sample types. The Company has received FDA approval for use of the test in detecting HCV antibodies in venous whole blood and finger-stick whole blood specimens. The OraQuick HCV test has received a Conformite Europeenne (CE) mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe and other foreign countries.

OraSure QuickFlu Rapid Flu A&B Test

The Company’s OraSure QuickFlu rapid flu A&B test is an FDA 510(k) cleared rapid 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. This product is manufactured under an agreement with Princeton BioMeditech Corporation. The OraSure QuickFlu test is y available for sale in certain United States markets.

OraSure Collection Device

The Company’s OraSure oral fluid collection device is used in conjunction with screening and confirmatory tests for HIV-1 antibodies and other analytes. This device consists of a small, treated cotton-fiber pad on a handle that is placed in a person’s mouth for two to five minutes. The OraSure collection device is FDA approved for use in the detection of HIV-1 antibodies and 510(k) cleared for the detection of cocaine and cotinine in oral fluid specimens.

Intercept Drug Testing System

A collection device that is substantially similar to the OraSure device is sold under the name Intercept, and is used to collect oral mucosal transudate (OMT) for oral fluid drug testing. The Company received FDA 510(k) clearance to use the Intercept collection device with laboratory-based EIAs to test for drugs of abuse commonly identified by the National Institute for Drug Abuse (NIDA) as the NIDA-5 l (THC or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (PCP)), and for barbiturates, methadone and benzodiazepines.

Cryosurgical Systems (Skin Lesion Removal Products)

The Company’s 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. The Company has 510(k) clearance for use of the Histofreezer product to remove common warts and eight other types of benign skin lesions. Internationally, it sells an OTC cryosurgical product through its distributor Genomma Labs, under the POINTTS trade name, in Mexico and a number of South and Central American countries. It also sells a CE marked cryosurgical wart removal product into the OTC footcare market in Europe, Australia and New Zealand through its distributor, Reckitt Benckiser (Reckitt), under the Scholl and Dr. Scholl trademarks. In 2011, it began selling OTC cryosurgical products for the treatment of both warts and skin tags to retailers in Canada on a private label basis.

Molecular Collection Systems

The Company’s wholly owned subsidiary, DNAG, sells a number of products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA and/or RNA from human and animal biologic samples. DNAG’s lead product is sold under the Oragene name and is used to collect DNA from human saliva. DNAG products are available in several different configurations and contain chemical solutions that are optimized for the specific application each product is designed for.

Immunoassay Tests and Reagents

The Company develops and sells immunoassay tests in two formats: MICRO-PLATE and AUTO-LYTE, to meet the specific needs of its customers. MICRO-PLATE tests can be performed on commonly used instruments and can detect drugs in urine, serum and sweat specimens. MICRO-PLATE tests are also 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.

Western blot HIV-1 Confirmatory Test

The Company sells an oral fluid Western blot HIV-1 confirmatory test that received premarket approval from the FDA. This test uses the original specimen collected with the OraSure oral fluid collection device to confirm positive results of initial oral fluid HIV-1 EIA screening tests.

Q.E.D. Saliva Alcohol Test

The Company’s Q.E.D. saliva alcohol test is a point-of-care test device that is an alternative to breath or blood alcohol testing. The United States Department of Transportation (DOT) has also approved the test. The product has a testing range of 0 to 0.145% blood alcohol and produces results in approximately two minutes.

The Company competes with Johnson & Johnson, Bio-Rad Laboratories, Abbott, Maxim Biomedical, Trinity Biotech, Alere, MedMira, Ansys Technologies, Dade Behring, Psychemedics, Immunalysis, Thermo Scientific, Roche Diagnostics, Wartner, Cryosurgery, Inc., Chematics, Intoximeters, Drager, Siemens, and CMI.