bioMérieux Completes its VIDAS® Hepatitis Panel with a New Test for the Diagnosis of Hepatitis C

Marcy l’Etoile, France, May 3, 2012 — bioMérieux, a world leader in the field of in vitro diagnostics, announces the launch of VIDAS® Anti-HCV for the detection of the hepatitis C virus (HCV). With this new CE marked test, VIDAS® now has a complete hepatitis menu with tests for A, B and C viral hepatitis.

This new test was developed by bioMérieux on the automated VIDAS system, which has the world’s largest installed base of any immunoassay system in clinical laboratories. It is intended for use as an aid in the diagnosis of HCV in conjunction with other clinical information in individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. It is also used in combination with HAV and HBV assays to form a panel for the differential diagnosis of
viral hepatitis.

“We are very pleased to enhance our infectious disease offering with a new test addressing a major public health issue,” said François Lacoste, Corporate Vice President, bioMérieux Immunoassays Unit. “With 26,000 VIDAS and mini VIDAS® systems installed in clinical labs, this complete hepatitis assay panel will be widely available to doctors.”

VIDAS Anti-HCV detects all 6 HCV genotypes with a specificity of 99,61% (as tested in a blood donor population) and sensitivity of 99,77% (as determined in a population including immunocompromised patients). The test provides rapid results in 40 minutes and combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection. Core, NS3 and NS4 antigens are used for the qualitative detection of anti-HCV antibodies in serum or plasma. The assay provides a cost-effective solution with single dose tests, an all-inclusive kit and a convenient 60 test packaging size.

The hepatitis C virus (HCV) infection causes a serious inflammation of the liver. A major public health issue, an estimated 3% of the world’s population is infected with HCV. Most of the acute infections are asymptomatic and 130 to 200 million people worldwide suffer from chronic hepatitis C. HCV accounts for 1 in every 40 deaths globally and an estimated 2.3 – 4.7 million new infections occur annually.

About VIDAS®
With 26,000 VIDAS® and mini VIDAS® systems in clinical laboratories, bioMérieux has the largest installed base worldwide of any immunoassay system. Around the world, three VIDAS tests are done every second. These systems offer multi-parameter instruments using ELFA (Enzyme Linked Fluorescent Assay) technology, based on a ready-to-use single-sample test concept. The analyses may be run in a series or individually. Launched in 1992, the VIDAS product range has earned a  reputation for quality and reliability. Today the VIDAS menu includes 98 parameters covering a wide range of human pathologies: identification and quantification of bacteria, viruses and parasites, antibodies measuring the immunological response to an infection and different proteins circulating in the blood, markers for selected cardio-vascular diseases and certain cancers, inflammatory response and hormonal dysfunction.