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FDA Clears Roche's Second-Generation Hepatitis B MDx Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Roche Molecular Diagnostics' second-generation Cobas AmpliPrep/Cobas TaqMan HBV Test.

The molecular test provides quantitative detection of hepatitis B virus DNA in human plasma or serum for patients on hepatitis B virus antiviral therapy. The test is a run on a platform that combines automated sample preparation on the Cobas AmpliPrep with automated real-time PCR amplification and detection on the Cobas TaqMan Analyzer or smaller Cobas TaqMan 48 analyzer.

The newest version of the test uses a reduced sample input volume of 650 uL of either serum or plasma specimens and is standardized against the World Health Organization standard for hepatitis B, according to Roche.

"Viral load testing remains the gold-standard for the management of HBV antiviral therapy," Teresa Wright, chief medical officer of Roche Molecular Diagnostics, said in a statement. "Roche's new HBV test provides accurate and reproducible results at the key medical decision points, allowing the clinician to optimize patient outcomes."

Roche cited statistics from the US Centers for Disease Control and Prevention showing that 1.2 million people in the US have chronic hepatitis B, with around 43,000 people newly infected with the disease each year.

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