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FDA clears Roche Hepatitis B viral load test

Roche Molecular Diagnostics has received the US Food and Drug Administration (FDA) approval for the COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0 (Hepatitis B viral load test), for use in the US.

Roche claims that its new test provides a fully automated solution for the quantitative detection of hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy.

Roche Molecular Diagnostics president and CEO Paul Brown said that this new test enables clinicians to follow best practices in patient care with standardised viral load measurements, a broad range of detection, and high sensitivity and the system is also carefully designed to protect the integrity of each patient result, so clinicians can make key medical decisions about therapy with confidence.

Roche Molecular Diagnostics chief medical officer Teresa Wright said that viral load testing remains the gold-standard for the management of HBV antiviral therapy and Roche’s new HBV test provides accurate and reproducible results at the key medical decision points, allowing the clinician to optimise patient outcomes.