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Roche Gets European OK to Sell HBV Test for Clinical Use

NEW YORK (GenomeWeb News) – Roche Molecular Diagnostics has received the CE-IVD Mark from European regulatory authorities allowing the firm to sell its Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0 for clinical use in the European Union.
 
The test uses Roche’s real-time PCR technology for quantitative detection of hepatitis B virus DNA in patient plasma and serum. The test detects genotypes A-H and pre-core mutants, Roche noted in a statement. The firm also said that the test offers broader dynamic range than previous generation tests — from as low as 20 IU/mL and as high as 1.7E+08 IU/mL — which enables improved viral load monitoring.
 
The test runs on Roche’s automated platform, which consists of the Cobas AmpliPrep Instrument for automated sample preparation and the Cobas TaqMan Analyzer or smaller Cobas TaqMan 48 Analyzer for automated real-time PCR amplification and detection.
 
“It is critical to monitor the levels of circulating hepatitis B virus as an indicator as to when hepatitis B therapies should be started, and to determine response to treatment,” Teresa Wright, chief medical officer at Roche Molecular Diagnostics, said in a statement. “This test enables doctors to optimize patient treatment with standardized viral load measurements and enables laboratories to test efficiently with improved automation.”
 
In September, Roche gained US Food and Drug Administration clearance to market its Cobas TaqMan HBV test, which it said was the first hepatitis B viral load test approved for marketing by the FDA.
 

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