Cepheid Receives CE-IVD Clearance for Xpert® HBV Viral Load 

Simplify Hepatitis B Treatment Management 

SUNNYVALE, CALIF. – December 20, 2018— Cepheid today announced the CE-IVD marking of Xpert HBV Viral Load, a new rapid test for the quantitation of Hepatitis B Virus (HBV) that delivers results in less than an hour. Xpert HBV Viral Load is intended for use as an indicator of disease prognosis and as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. 

With the addition of Xpert HBV Viral Load to the GeneXpert® test portfolio, Cepheid now offers an extensive virology test menu suitable for implementation in any laboratory setting, making high-quality testing and disease monitoring accessible to an even broader demographic. 

Despite the effectiveness of vaccines that prevent HBV infection, an estimated 257 million people across the globe are living with a chronic HBV infection. HBV infection can lead to acute and chronic liver failure, and development of cirrhosis and hepatocellular carcinoma. In 2015, nearly 890,000 people worldwide died from complications of HBV infection, according to WHO estimates.

Medical providers are increasingly interested in test-and-treat strategies for HBV due to the development of more options for antiviral therapies that can mitigate risks associated with persistent infection. 

Run on the fully integrated GeneXpert platform, the Xpert HBV Viral Load provides reliable and ondemand testing that empowers clinicians with rapid and accurate results wherever and whenever they need. 

"Decentralized serologic testing for HBV has been available for several years, but administration of antiviral therapies requires confirmation of HBV DNA in plasma prior to treatment,” said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Our Xpert HBV Viral Load test provides sensitive and accurate quantitation of a wide range of HBV genotypes on a widely available random access platform that is suitable for implementation both in central labs and at the point of impact”.  

The new test is now available in the European Union and all countries recognizing the CE-mark. Xpert HBV Viral Load is not available in the United States. 

Ref: http://www.cepheid.com/us/about-us/news-events/press-releases/331-cepheid-receives-ce-ivd-clearance-for-xpert-hbv-viral-load