Ortho-Clinical Diagnostics, Inc. Launches New Early Detection HCV Test First Direct Detection Test for Hepatitis C Virus Core Antigen Now Available Outside the United States RARITAN, N.J., Aug. 31 /PRNewswire-AsiaNet/ -- A new in vitro diagnostic assay, ORTHO(R) Antibody to HCV Core Antigen ELISA Test System, is now commercially available in countries outside of the United States. This is the first test to be commercialized for the direct detection of HCV core antigen, a marker of early infection in Hepatitis C infected individuals. Availability of this assay will reduce the worldwide transmission of HCV infection through infected blood. HCV Ag Test System: Closing The Window For Hepatitis C Virus International field studies with the ORTHO HCV core antigen assay demonstrate a significant performance improvement versus current immunoassay techniques in closing the HCV infectious window by 40-50 days. Performance data shared at the 1st Scientific Symposium on Technology for the Detection of Hepatitis C Virus Core Antigen held in Paris in March 2000 established the HCV Ag test as a viable option for the identification of HCV infectious blood donor units throughout the world. "Implementing the HCV core antigen test to screen blood donations would significantly improve transfusion safety," said Anne-Marie Courouce, PhD, Head of the Unit of Virology at the National Institute of Blood Transfusion in Paris. Dr. Courouce presented data which showed the HCV Ag test detecting HCV infection approximately 49 days earlier than existing HCV antibody assays. ORTHO HCV core antigen assay is also the only direct detection test system available today which provides results in under 3 hours, is compatible with existing equipment and is suitable for large-scale screening of individual blood donors. "We have worked diligently to bring ORTHO Antibody to HCV Core Antigen ELISA Test System to market because of its potential to improve the safety of the world's blood supply," states Gerard Vaillant, Ortho-Clinical Diagnostics, Company Group Chairman Diagnostics Worldwide. "This assay has helped us continue the tradition of delivering breakthrough assays in the field of hepatitis." Worldwide Commercialization Commercialization of the ORTHO HCV core antigen assay will include product registration worldwide. "We are actively involved in registration processes in key geographies around the globe and will continue to participate in studies to further our development of diagnostic applications and the next generation Ortho HCV core antigen blood screening test," said Bill Skillman, Vice President, Transfusion Medicine, Ortho-Clinical Diagnostics. The Ortho HCV core antigen assay is currently registered for use in France and Hungary and available for sale in Spain and Belgium. The Investigational New Drug (IND) application for the United States filing was submitted to the U.S. Food and Drug Administration on August 30, 2000. About Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health-care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the Company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world's blood supply. In addition, through its patented dry slide and enhanced chemiluminescence technologies, the Company has transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions that promote effective diagnoses and enhance patient care. (Note: ORTHO is a registered trademark of Ortho-Clinical Diagnostics, Inc.) SOURCE: Ortho-Clinical Diagnostics, Inc. CONTACT: Gayle S. Mestel of CCS/PR, Inc., 760-438-5250, or fax, 760-438-5230, [email protected], for Ortho-Clinical Diagnostics, Inc. -END-