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Abbott's RealTime Hepatitis B Viral Load Test Receives CE Marking in Europe

Represents first and only molecular test capable of detecting and measuring all known forms of hepatitis B genotypes, providing a valuable tool for physicians in managing patient therapy.

Abbott and Celera, an Applera Corporation business, announced today that Abbott has received CE marking for a real-time PCR (polymerase chain reaction) test for monitoring hepatitis B (HBV) viral load in patients, allowing the test to be marketed in the European Union. Abbott is marketing the test under its strategic alliance with Celera.

The Abbott RealTime HBV test, developed for use on the Abbott m2000(TM) automated instrument system, is designed for the quantitation (precise measurement) of HBV in human plasma or serum from patients known to be infected with the virus. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and as an aid in assessing a patient's response to antiviral treatment. With the addition of the HBV test, the m2000 offers the broadest menu of molecular tests available on a single instrument platform. The m2000 menu includes real-time PCR tests for HIV-1, hepatitis C, chlamydia, and a combination test for chlamydia and gonorrhea.

Quantitative measurements of HBV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of patients with HBV. An initial measurement of HBV viral load can guide a decision to begin antiviral therapy, while monitoring HBV DNA levels during therapy can influence its duration and also signal the development of drug resistance.

In addition, the higher the baseline viral level the more likely a patient is to develop hepatocellular carcinoma, a primary cancer of the liver.

"The Abbott RealTime HBV assay is the only test currently available that targets an essential, highly conserved segment of the HBV genome, which
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