A Diagnostics & Imaging Week

Most people who become infected with the hepatitis C virus (HCV) not only suffer immediate effects of the disease, but they are predisposed to contract cancer. A quick test is needed to quash the growing spread of this infectious disease.

Answering the call, OraSure Technologies (Bethlehem, Pennsylvania) has just submitted a pre-market approval (PMA) application to the FDA for what will be the first rapid test for antibodies to the HCV.

If approved, the OraQuick HCV test is expected to be the first rapid HCV test approved for use in the U.S.

OraSure is seeking approval for use of its OraQuick HCV test on five specimen types, including oral fluid, fingerstick whole blood, venous whole blood, plasma and serum. The submission reflects the successful completion of clinical studies which include data from over 3,000 subjects.

"The completion of our FDA submission for the OraQuick HCV test is the result of a tremendous effort by our regulatory, research and development and operations groups, and we are very grateful for all of their efforts," said President/CEO Douglas Michels. "We believe the market opportunity for a rapid HCV test, both here in the U.S. and around the world, is very significant and this submission represents the achievement of an important milestone towards commercialization."

He added, "We look forward to launching this product in the U.S. in collaboration with Schering-Plough ... once FDA approval is obtained."

Schering-Plough (Kenilworth, New Jersey) and OraSure previously agreed to collaborate on the development and promotion of an HCV test using OraSure's OraQuick technology platform outside the U.S. The agreement expands an existing collaboration to develop and promote a rapid oral HCV test in the U.S. physicians' office markets.

Schering-Plough will reimburse OraSure for certain development costs and provide payments to OraSure based on the achievement of certain regulatory and commercial milestones in international markets. Schering-Plough also will provide promotional support for the product in international markets.

OraSure will make all sales of the HCV test, and OraSure will retain the rights to sell the test in all markets throughout the world. During the collaboration period, the test may, at Schering-Plough's option, be labeled and promoted under both Schering-Plough and OraSure trademarks.

There are an estimated 180 million people who are chronically infected with HCV, with an estimated three to four million individuals newly infected each year. The prevalence of hepatitis C infection is estimated to be four times that of HIV around the world.

The World Health Organization (Geneva, Switzerland) estimates that up to 50% of people infected with HCV are undiagnosed and up to 80% who have HCV show no signs or symptoms.

HCV is curable. With current treatment therapies, the rates of sustained viral clearance are as high as 50% in cases of infection by Genotype 1, the most common form of HCV.

The HCV test is based on technology from the company's FDA-approved OraQuick rapid test platform for HIV-1. When whole blood, serum or plasma is to be tested, a loop collection device is used to collect the sample and insert it into the developer solution, after which the collection pad is inserted into the solution. The specimen and solution then flow through the testing device where results are observable in about 20 minutes.

According to the National Cancer Institute (Bethesda, Maryland), more than 21,000 new cases of liver cancer will be diagnosed in the U.S. in 2008, with 18,000 patients dying of liver cancer in the same year.