OraSure Technologies (OSUR) has recently filed with the U.S. Food and Drug Administration (“FDA”) an application for a waiver under the Clinical Laboratory Improvement Amendments (“CLIA”) for its OraQuick hepatitis C (“HCV”) Rapid Antibody Test for use with venous and finger-stick whole blood samples. CLIA is the U.S. regulatory standard for all human clinical laboratory testing.

The OraQuick HCV, which was launched in the U.S. in July 2010, is the first and only rapid HCV test approved by the FDA for the identification of antibodies to the HCV virus. OraSure received CE Mark approval for the test in December 2009 and it was launched in Europe in 2010 for use with oral fluid, whole blood, serum and plasma samples.

Roughly 180 million individuals are estimated to be infected with HCV globally, with about 3 to 4 million new cases annually. The disease affects about 4 million people in the U.S. According to the World Health Organization (“WHO”), a majority of the cases go undiagnosed and as many as 80% of HCV-positive cases do not exhibit any symptom.

The OraQuick HCV test is used for identifying HCV antibodies in venous whole blood and finger-stick whole blood specimens. It leverages the OraQuick technology platform and provides readings in about 20 minutes.

OraQuick HCV, which is currently categorized as a moderately complex test, can be used by roughly 40,000 CLIA-certified laboratories. According to the Centers for Medicaid and Medicare Services (“CMS”), the CLIA waiver application, if eventually approved, will broaden the access of the test to more than 180,000 sites across the U.S. including physician offices, outreach clinics and community-based organizations.

OraSure has collaborated with Merck & Co. (MRK) on the development and marketing of the OraQuick HCV test. Under the deal terms, OraSure has been and may continue to be reimbursed by Merck for a portion of the expenses incurred to develop and obtain regulatory approval for the test. Merck will also provide promotional assistance, including explanation of the test in the physicians’ office setup, across the U.S. and internationally.

OraSure markets oral fluid specimen collection devices based on its proprietary oral fluid technologies, diagnostic products including immunoassays and in vitro diagnostic tests, and certain other medical devices.

It is also a leading supplier of oral-fluid solutions for testing drugs of abuse as well as identification of antibodies to human immunodeficiency virus (“HIV”). The company’s major competitors include Abbott Labs (ABT) and Bio-Rad Laboratories (BIO).

 
ABBOTT LABS (ABT): Free Stock Analysis Report
 
BIO-RAD LABS -A (BIO): Free Stock Analysis Report
 
MERCK & CO INC (MRK): Free Stock Analysis Report
 
ORASURE TECH (OSUR): Free Stock Analysis Report
 
Zacks Investment Research