Roche wins CE Mark for new hepatitis test

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Roche wins CE Mark for new hepatitis test

9th December 2008

By Staff Writer

Roche Molecular Diagnostics has received CE Mark certification for its new Cobas

AmpliPrep/Cobas TaqMan HBV Test v2.0, allowing it to be sold for clinical use in

the EU.

This highly sensitive test offers Roche's fully automated real-time polymerase

chain reaction (PCR) technology to achieve a broad range for the quantitative

detection of hepatitis B virus DNA in patient plasma and serum.

According to the company, the Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0 can

detect genotypes A-H and pre-core mutants. It offers a broader range than

previous generation tests, from as low as 20IU/ml and as high as 1.7E+08 IU/ml,

enabling physicians to improve viral load monitoring. The assay offers both

serum and plasma specimen type and only uses 650 microliters sample processing

volume.

This test is designed for use on Roche's automated platform that was CE Mark

certified in 2005. The platform combines the Cobas AmpliPrep instrument for

automated sample preparation and the Cobas TaqMan analyzer or the smaller Cobas

TaqMan 48 analyzer for automated real-time PCR amplification and detection.

, chief medical officer of Roche Molecular Diagnostics, said: " This

test enables doctors to optimize patient treatment with standardized viral load

measurements and enables laboratories to test efficiently with improved

automation. "