OraSure, Schering-Plough Working on Rapid Test for Hepatitis C

On Thursday, the maker of the oral HIV test, OraSure Technologies, joined Schering-Plough Corp. to announce a partnership to develop and market a rapid-result oral hepatitis C virus (HCV) test. Pennsylvania-based OraSure has previously announced it expects to begin clinical trials of a candidate HCV test this year. The firm did not predict when the test might receive Food and Drug Administration approval.

"As a long-term innovator and leader in the hepatitis therapy area, Schering-Plough is the ideal partner to help us introduce our rapid, point-of-care [hepatitis C] test to the US physicians' market," Douglas Michels, OraSure's CEO, said in a statement. "We believe a rapid oral fluid test has significant commercial and medical value in that it will help identify more individuals who are infected, thus enabling them to receive appropriate treatment."

HCV affects about 4 million US residents, and many of them are unaware they have the most common blood-borne infection. HCV can cause cirrhosis, liver cancer and liver failure. It is the leading reason for liver transplants.

For OraSure's OraQuick rapid HIV test, a health care worker swabs saliva from a patient's mouth, inserts the swab into a receptacle, and receives results in about 20 minutes indicating antibody-positive or -negative.

Under the two-year agreement, New Jersey-based Schering-Plough will help subsidize OraSure's development costs and also help market the product to U.S. physicians' offices. The test will incorporate the OraQuick name and Schering-Plough's "Be In Charge" program, which provides patients with information about chronic HCV. Sales will be made by OraSure, the joint statement read.

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