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Medical Devices / Submissions and Approvals

Cepheid’s Hepatitis B Viral Load Test Gains CE Mark

Dec. 28, 2018

Cepheid has received the CE Mark for a rapid molecular assay, the Xpert HBV Viral Load Test, which measures viral loads of Hepatitis B in patients.

Using Cepheid’s GeneXpert system, the test measures a patient’s HBV DNA levels via plasma or serum samples and produces quantitative results in less than an hour.

The test can be used for predicting the likely development of a disease and to measure a patient’s response to antiviral treatment.

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