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Sep 1, 2010

FDA Gives Abbott a Thumbs-Up for Automated HBV Monitoring Test

  • Abbott received approval from the FDA to market the Abbott RealTime HBV assay for quantitation of HBV in plasma or serum from chronically infected individuals. It is the first and only sanctioned test capable of automating HBV viral-load testing from sample extraction to final results, according to the company.

    The Abbott RealTime HBV assay, based on real-time PCR technology, is now available for laboratories that use the Abbott m2000 automated instrument system for molecular diagnostic testing. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.

    It detects and measures all known HBV genotypes by targeting an essential, highly conserved segment of the HBV genome. In addition, the Abbott RealTime HBV assay offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient's blood, the company notes.

    Use of the assay to determine the clinical stage of HBV infection has not been established. The assay is also not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.

    The Abbott RealTime HBV assay, initially introduced in Europe and other markets in 2007, was developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing. The m2000 is designed to detect viruses and bacteria in patient samples in less than six hours. It is available in most major markets throughout the world.

    Outside the U.S., an extensive menu for infectious disease testing is available that includes HIV-1 viral load, HBV viral load, chlamydia, chlamydia/gonorrhea combination, HCV viral load, HCV genotyping, cytomegalovirus, Epstein Barr virus, and HPV. In December 2009, Abbott Molecular introduced the first oncology assay on its m2000 system outside the U.S.—the Abbott RealTime mS9 Colorectal Cancer—which detects the methylated form of Septin 9, a gene linked to colorectal cancer, in blood specimens. In the U.S., the following tests are currently available on the m2000 platform: RealTime HIV-1, CT/NG, and now HBV.


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