Roche improves cutting-edge portfolio for early hepatitis C diagnosis and targeted treatment

Rotkreuz, 06. März 2012

Elecsys® anti-HCV II immunoassay from Roche receives CE mark

Roche now offers a fully updated state-of-the-art portfolio for the early detection of hepatitis C virus (HCV) infection and personalized disease management. The improved diagnostics and patient monitoring solution provides an one-stop shop for HCV testing with unprecedented performance in early infection and ease of use, allowing clinicians to work efficiently and to suit individual patient treatment.1

Early detection of HCV infection is vital in order to provide consolidated care of acute and chronic infection, and adequate treatment of drug response monitoring are crucial to overall therapy success. Patients undergoing a peginterferon alfa-2a and ribavirin therapy can be monitored precisely by real-time PCR measurement.

With the novel Elecsys anti-HCV II immunoassay on cobas® e modules Health Care Professionals get a cutting-edge tool for the early qualitative detection of antibodies against HCV. The updated assay with CE mark approval delivers enhanced convenience, specificity, increased reliability and consistency for improved efficiency in screening patients and blood donors.1

Following the identification of HCV antibodies, testing for HCV RNA, which is a crucial marker in the management of hepatitis C, confirms the infection and aids clinicians in predicting treatment response. In December 2011, Roche also received the CE mark for its HCV RNA qualitative and quantitative tests, which offer sensitive detection of HCV RNA and viral load measurement for predicting drug response on the COBAS® AmpliPrep/COBAS® TaqMan® fully automated platform.

As Personalized Healthcare has already begun to add true medical value for health professionals and patients, Roche’s novel portfolio underlines the clear shift from an ‘equal shares for all’ principle toward a target oriented and response-guided therapy approach. Out now, the updated portfolio of HCV testing and monitoring from Roche delivers a convenient set of tools to laboratories and clinicians to improve patient care.

About hepatitis C

World Health Organization figures show that around 200 million people globally are infected with HCV, which is particularly concentrated in the blood. Around 170 million people are chronic carriers of the virus, which can lead to cirrhosis, liver failure, and hepatocellular carcinoma.2 Identifying HCV infection is difficult because there are often no symptoms. Most cases go undetected and there is currently no vaccine to prevent infection. Many countries are currently unable to screen blood donations for infections such as hepatitis C.3

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

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1)Esteban Juan et al (2012). Elecsys anti-HCV II: a sensitive and specific assay for diagnosing hepatitis C virus (HCV) infection. In: Hepatology, Vol. 6, N° 1; Zitzer Heike et al (2011). Clinically Relevant HCV RNA Viral Load Results Using a Sensitive, Quantitative Assay. 7th European Meeting on Molecular Diagnostics, October 12-14, 2011, Scheveningen, the Netherlands
2)World Health Organization. Hepatitis C. Fact sheet N°164. Retrieved from on February 19, 2012.
3)World Health Organization. Blood Safety and Availability. Fact sheet N°279. Retrieved from on February 19, 2012.