Healthcare Industry News:  Roche Diagnostics 

Diagnostics Regulatory

 News Release - April 8, 2008

Roche Diagnostics Expands Availability of HCV Immunoassay

ROTKREUZ, Switzerland, April 8 (HSMN NewsFeed) -- Roche Diagnostics announced today that the Elecsys Anti-HCV (Hepatitis C Virus) assay has received regulatory approval in Europe for the E 170 analyzer for MODULAR ANALYTICS and the e 601 module for the cobas 6000 platform. The Elecsys Anti-HCV assay is already available on the Elecsys 2010 and the cobas e 411 instruments.

Hepatitis C virus (HCV) infection represents a major cause of death through the development of severe fibrosis, cirrhosis and liver cancer. The principal mode of transmission is parenteral exposure to infected blood or blood products i.e. insufficient blood screening procedures mainly in developing countries, and contaminated needles or other invasive medical tools. Most people with hepatitis C became infected through blood transfusions received before 1992, the year when improved blood screening tests became available.

Acute Hepatitis C infection is often asymptomatic and many people are unaware that they are infected until they present with the complications of liver disease. Therefore elevated liver enzymes are often the first signs of chronic HCV infection. HCV antibody tests are used for the primary diagnosis of hepatitis C virus infection in patients with suspected liver disease.

"The addition of anti-HCV assay to the E 170 analyzer for MODULAR ANALYTICS and the e601 module for the cobas 6000 platform complements Roche's already comprehensive menu of hepatitis immunodiagnostic and liver function assays, all of which can be accurately and simultaneously measured on a single blood sample to identify the underlying liver disorder." said Dirk Ehlers, Head of Roche Professional Diagnostics. "The addition of the E 170 / cobas e 601 application for Anti-HCV is another important step in demonstrating Roche's commitment to addressing our customers needs in terms of laboratory efficiency and convenience."

The Elecsys Anti-HCV test will be available internationally upon approval of the local regulatory agencies.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at

Source: Roche Diagnostics

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