Technology
OraSure Technologies has been a leader in oral fluid diagnostics since the launch of its first oral fluid HIV test in 1988. Since that time, the Company has become the global leader in oral fluid diagnostic technology, bringing to market products that significantly improve the way diagnostic testing is conducted.
OraSure's two platform technologies – OraQuick® and OraSure® – provide the foundation for its expanding infectious disease and substance abuse product lines.
The OraQuick® rapid test platform for oral fluid, fingerstick, whole blood and plasma, has been approved by the FDA for testing for HIV-1 and HIV-2 antibodies. The FDA has also approved a rapid test for antibodies to the Hepatitis C virus utilizing the OraQuick® technology platform for fingerstick and whole blood. Additionally, the OraQuick® HCV test is CE-marked approved for use with oral fluid, whole blood, serum and plasma in the EU.
The OraSure® Oral Specimen Collection Device is a generic device which was developed and FDA approved for the purpose of collecting, preserving, and transporting oral fluid specimens. It completely eliminates the risk associated with handling needles and blood. This platform is currently utilized by OraSure for HIV-1 and drugs of abuse testing.
OraSure also develops and markets a proprietary cryogenic technology for the treatment of warts and other benign skin lesions. This technology is sold as the Histofreezer® Portable Cryosurgical System to professional markets in the United States and many foreign countries. The technology is also sold as an over-the-counter product in several countries around the world.
In addition, through its wholly-owned subsidiary, DNA Genotek Inc., the Company also is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. 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.
