Point-of-care diagnostics provider OraSure Technologies has entered into a Master Program Services and Co-Promotion Agreement with AbbVie under which AbbVie and OraSure will co-promote the company's OraQuick HCV Rapid Test in the United States. The product will be used to test individuals at-risk for hepatitis C (HCV). OraSure will be responsible for manufacturing and selling the product directly into all markets.
According to the Centers for Disease Control and Prevention (CDC), HCV is the most common chronic blood-borne infection in the United States, with approximately five million people infected. It is estimated that one in 30 Baby Boomers (adults born between 1945 and 1965) have chronic hepatitis C, and up to 75% of people infected with HCV are unaware of their infection. The CDC, the U.S. Preventative Services Task Force, and the American Association for the Study of Liver Diseases all have issued guidance that recommends HCV testing for at-risk individuals including all Baby Boomers.
“We believe it is critical that at-risk individuals be tested for hepatitis C to prevent serious consequences from untreated infection,” says Douglas A. Michels, President and CEO of OraSure Technologies. “This new collaboration allows us to educate healthcare professionals and the patients they treat about hepatitis C and provide them with a very important rapid diagnostic tool.”
The OraQuick HCV test is an FDA-approved and CLIA-waived POC test for detection of HCV infection in at-risk individuals. Its platform enables healthcare providers to deliver a diagnosis based on test results in 20 minutes, using fingerstick or venipuncture blood. Read the FDA’s summary of safety and effectiveness and labeling for the product.Read more