Abbott test gets mark of certification

Abbott Laboratories has announced that its real time hepatitis B viral load (HBV) test has been granted the CE mark, making it eligible for marketing in the EU.

The hepatitis test is the first and only molecular version capable of measuring all hepatitis B genotypes, according to Abbott, enabling it to monitor the viral load in patients.

Abbott’s latest test is designed for use on the m2000, which is also capable of carrying out polymerase chain reaction tests for HIV-1, hepatitis C, chlamydia, as well as a combination test for chlamydia and gonorrhea.

“The Abbott RealTime HBV assay is the only test currently available that targets an essential, highly conserved segment of the HBV genome, which makes it a very reliable test for detecting and measuring all known HBV genotypes,” said John Robinson, PhD, senior director of research and development at Abbott Molecular.

“It gives physicians one of the most precise tests available to guide treatment decisions and builds upon Abbott’s 30-year legacy in hepatitis testing.”

The m2000 is currently marketed in Europe in association with Celera and Abbott has said that it will be marketing the new HBV test in the same manner.

Hepatitis B can lead to liver disease and liver cancer, according to the Department of Health, with early symptoms of the disease appearing flu-like.