Ortho Clinical Diagnostics today announced the U.S. Food and Drug Administration (FDA) approval of the VITROS® Anti-HCV assay for use on the VITROS 5600® Integrated and 3600® Immunodiagnostic Systems.
This approval marks a major milestone in the successful launches of Ortho Clinical Diagnostics’ clinical laboratory testing platforms, and enables the consolidation of hepatitis C testing with routine assays on the VITROS® 5600 Integrated System.
“This approval builds upon Ortho Clinical Diagnostics’ history as the innovator of automated hepatitis C testing for clinical laboratories,” said Michael Samoszuk, M.D., Chief Medical Officer, Ortho Clinical Diagnostics. “Clinicians can now test for hepatitis C as a part of their routine assay testing on the VITROS® Systems, which will help make labs more efficient in delivering quality results.”
According to the Centers for Disease Control and Prevention (CDC), a person can only be diagnosed with hepatitis C after a positive result for an anti-HCV screening test has been verified
Hepatitis C is often referred to as the “silent disease” because up to 70 percent of people with the disease do not typically experience any symptoms.
The VITROS® Anti-HCV assay is an in vitro diagnostic immunoassay for the qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. It can be run with excellent precision, sensitivity, low sample volume requirements and quick, random access results on the VITROS® Systems, with results readily available in 55 minutes.
The approval of the VITROS® Anti-HCV assay will now expand the availability of hepatitis C testing across all of Ortho Clinical Diagnostics’ VITROS® immunoassay platforms, including the VITROS® ECi/ECiQ and VITROS® 3600 Immunodiagnostic Systems and the VITROS® 5600 Integrated System. Standardized VITROS® reagents and results will enable laboratories to better manage reagent inventories and costs in addition to producing consistent test results from platform-to-platform. This is particularly beneficial for laboratories with multiple VITROS® platforms in their facilities.
Since the introduction of the VITROS® 5600 Integrated and the VITROS® 3600 Immunodiagnostic Systems within the last year, Ortho Clinical Diagnostics has released more than 100 assays on these new platforms in the United States. In certain international markets, Ortho Clinical Diagnostics has launched 118 assays, including hepatitis B, hepatitis C and HIV assays. Ortho Clinical Diagnostics’ broad, world-class menu of immunoassays covers major disease states including cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions and anemia. The company’s VITROS® assay menu covers up to 90 percent of the top 100 assays and 99 percent of laboratory test volume, with numerous other assays in development.
The FDA has also approved the VITROS® Anti-HBc IgM assay for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems for hepatitis B testing. Additional hepatitis B and HIV assays, already available for use on the VITROS® ECi/ECiQ Immunodiagnostic Systems, are currently under review or pending submission to the FDA for approval for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems.
Upon full menu approval, only Ortho Clinical Diagnostics’ VITROS® 5600 Integrated System will offer a complete infectious disease testing menu in the US, including HIV, in addition to a comprehensive menu of routine assays that can be run on a single platform.
