Cepheid Receives CE-IVD Clearance for Xpert® HBV Viral Load
SUNNYVALE, Calif., Dec. 20, 2018
SUNNYVALE, Calif., Dec. 20, 2018 /PRNewswire/ -- 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 infection1. 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 estimates1.
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 on-demand 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.
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.
- WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; 2017. License: CC BY-NC-SA 3.0 IGO. Accessed November 2018. http://apps.who.int/iris/bitstream/handle/10665/254621/9789241549981-eng.pdf;jsessionid=EA06739644E7C99EBAE38683510DCE6A?sequence=1
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