Medical Device Network

Daily Newsletter

27 November 2023

Daily Newsletter

Roche expands Elecsys portfolio and launches Hepatitis B immunoassay

The Elecsys HBeAg quant test provided both qualitative and quantitative measurements of Hepatitis B e antigen.

Roche has launched a qualitative and quantitative immunoassay, Elecsys HBeAg quant, to diagnose and monitor hepatitis B.

The test can detect the presence of hepatitis B e antigen (HBeAg) in human serum and plasma to diagnose hepatitis B. It can also quantify the viral load to determine the activity of the disease for treatment and monitoring purposes.

Hepatitis B in vitro diagnostic market is forecasted to grow from $991.2m in 2023 to over $1.1bn in 2030, as per a GlobalData market model. The market is expected to grow at a compound annual growth rate (CAGR) of 2.16%.

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). It can spread through contact with infected body fluids like blood, saliva, vaginal fluids, and semen. It can also be passed from a mother to her baby, through the placenta.

The World Health Organization (WHO) has identified hepatitis B as a major global health problem, with the highest infection rates in the western Pacific and African regions. Hepatitis B is a preventable disease with the neonatal hepatitis B vaccine. Hepatitis B can only be diagnosed through in vitro testing as it is clinically indistinguishable from other hepatitis.

As the Elecsys HBeAg quant test provides both qualitative and quantitative analysis, it is expected to improve workflow and reduce complexity for lab personnel. The quantitative analysis provided by the test can also be used to design a personalised treatment for hepatitis B patients.

The quant test can also be used for perinatal screening, in cases where no access to HBV DNA testing is available. Additionally, test can be used on the cobas e analysers in CE mark accepting countries.

Roche also has hepatitis E immunoassay as part of its portfolio. Recently, the Swiss company launched an automated version of the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections. Roche Elecsys’s portfolio also includes a neurofilament light chain (NfL) test for diagnosing multiple sclerosis test, interleukin 6 (IL-6) immunoassay for diagnosing neonatal sepsis, and beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (

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