OraSure Technologies, a market leader in point of care diagnostics, announced that it 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.
Under the agreement, OraSure has granted exclusive promotion rights to AbbVie for the OraQuick® HCV test in certain markets and will provide certain additional services in support of HCV testing. In exchange for the exclusive rights granted to AbbVie, OraSure will receive up to $75 million in exclusivity payments over the term of the agreement, which runs through December 31, 2019. In addition, upon achievement of certain performance-based milestones, OraSure will be eligible to receive additional payments annually over the life of the agreement. Further information regarding the agreement will be available in the Company's 8-K Report filed later today with the SEC.
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 5 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 the people infected with HCV are unaware of their infection. The CDC, the U.S. Preventative Services Task Force (USPSTF), and the American Association for the Study of Liver Diseases (AASLD) have all 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," said Douglas A. Michels, President and Chief Executive Officer 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 the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using fingerstick or venipuncture blood.
Under the agreement, OraSure has granted exclusive promotion rights to AbbVie for the OraQuick® HCV test in certain markets and will provide certain additional services in support of HCV testing. In exchange for the exclusive rights granted to AbbVie, OraSure will receive up to $75 million in exclusivity payments over the term of the agreement, which runs through December 31, 2019. In addition, upon achievement of certain performance-based milestones, OraSure will be eligible to receive additional payments annually over the life of the agreement. Further information regarding the agreement will be available in the Company's 8-K Report filed later today with the SEC.
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 5 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 the people infected with HCV are unaware of their infection. The CDC, the U.S. Preventative Services Task Force (USPSTF), and the American Association for the Study of Liver Diseases (AASLD) have all 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," said Douglas A. Michels, President and Chief Executive Officer 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 the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using fingerstick or venipuncture blood.