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Roche gains first hepatitis B viral load test approval

This article was originally published in The Gray Sheet

Executive Summary

Firm's Cobas TaqMan nucleic acid test for hepatitis B virus gains PMA approval Sept. 4. The first-of-its-kind quantitative test will enable doctors and laboratories to conduct the same viral load testing for HBV that they now do for HIV and hepatitis C, says Teresa Wright, chief medical officer at Roche Molecular Diagnostics. Used with other clinical findings, such as results from biochemical and serological testing, Cobas extracts and then amplifies sections of viral DNA from human plasma or serum, which are then measured to establish a baseline level before beginning treatment. The DNA sections are used again during treatment to assess an individual's response to therapy. Roche's Cobas TaqScreen MPX, which screens patients for HBV, HCV and HIV, has been available in Europe since 2006 ("1The Gray Sheet" Sept. 3, 2007, p. 8)
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