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Abbott Receives CE Marking For PCR Test For Monitoring Hepatitis B Viral Load In Patients
  6/21/2007 7:09:40 AM Abbott (ABT) on Thursday revealed the receipt of CE marking for a real-time PCR test for monitoring hepatitis B viral load in patients. The company noted that the approval would permit the test, which is being marketed under strategic alliance with Celera, to be marketed in the European Union. According to the company, the test, which is developed for use on the Abbott m2000 automated instrument system is designed for the quantitation of HBV in human plasma or serum from patients known to be infected with the virus. The test is expected to help in assessing a patient's response to antiviral treatment, and also as an of disease prognosis.
Abbott currently markets the m2000 system and a menu of tests in countries throughout the world as part of a strategic alliance with Celera. In Europe, the instrument's menu includes assays for HIV-1 viral load, HCV viral load, chlamydia, and a combination test for chlamydia and gonorrhea.
According to the World Health Organization, around two billion people have been affected by hepatitis B, with over 350 million of them suffering from chronic infections.
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