FDA Approves VITROS(R) Anti-HCV Assay For Use On VITROS 5600(R) Integrated And VITROS 3600(R) Immunodiagnostic Systems

Main Category: Liver Disease / Hepatitis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jul 2009 - 2:00 PDT

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Ortho Clinical Diagnostics announced the U.S. Food and Drug Administration (FDA) approval of the VITROS((R)) Anti-HCV assay for use on the VITROS 5600((R)) Integrated and 3600((R)) 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((R)) 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((R)) 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(1). 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(2).

The VITROS((R)) 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((R) )Systems, with results readily available in 55 minutes.

The approval of the VITROS((R)) Anti-HCV assay will now expand the availability of hepatitis C testing across all of Ortho Clinical Diagnostics' VITROS((R)) immunoassay platforms, including the VITROS((R)) ECi/ECiQ and VITROS((R)) 3600 Immunodiagnostic Systems and the VITROS((R)) 5600 Integrated System. Standardized VITROS((R)) 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((R)) platforms in their facilities.

Since the introduction of the VITROS((R)) 5600 Integrated and the VITROS((R)) 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((R)) 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((R)) Anti-HBc IgM assay for use on the VITROS((R)) 5600 Integrated and VITROS((R)) 3600 Immunodiagnostic Systems for hepatitis B testing. Additional hepatitis B and HIV assays, already available for use on the VITROS((R)) ECi/ECiQ Immunodiagnostic Systems, are currently under review or pending submission to the FDA for approval for use on the VITROS((R)) 5600 Integrated and VITROS((R)) 3600 Immunodiagnostic Systems. Upon full menu approval, only Ortho Clinical Diagnostics' VITROS((R)) 5600 Integrated System will offer a complete infectious disease testing menu in the U.S., including HIV, in addition to a comprehensive menu of routine assays that can be run on a single platform.

About Hepatitis C

Hepatitis C is a virus that causes inflammation of the liver. If left untreated, it can become chronic and progress to liver disease, which can be serious or even life-threatening. According to the CDC, hepatitis C is the most common blood-borne infection in America. It is estimated that 3.2 million people are chronically infected by hepatitis C virus, which is mostly transmitted through contact with blood or blood products. The most common modes of transmission are transfusion of blood from unscreened donors or sharing contaminated needles. While much less common, hepatitis C virus can also be transmitted from mother to infant at childbirth, through sexual intercourse with an infected person, tattooing or body piercing and accidental needle sticks in healthcare settings(2,3).

About the VITROS((R) )3600 Immunodiagnostic System

The VITROS((R)) 3600 Immunodiagnostic System is a high-capacity immunoassay system with Intelligent Sample Management for routine and specialty testing. The VITROS((R)) 3600 Immunodiagnostic System offers a broad menu of 47 immunoassays, covering disease states such as cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions and anemia.

About the VITROS((R) )5600 Integrated System

The VITROS((R)) 5600 Integrated System is a high-capacity system that integrates clinical chemistry and immunoassay testing on one platform using innovative Sample Centered Processing. The VITROS((R)) 5600 platform is smaller than many other systems and does not have any water or drainage requirements, making the most of limited lab space while allowing flexibility in instrument location.

About Ortho Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers the high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care.

(1) Centers for Disease Control and Prevention. Laboratory Testing.

(2) Centers for Disease Control and Prevention. Hepatitis C.

(3) FAQs for the Public. Centers for Disease Control and Prevention.

Source: Ortho Clinical Diagnostics