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Hepatitis and Viral Load Testing

Platforms for qualitative and quantitative viral testing, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), were another key area of development. Roche launched its AMPLICOR® quantitative MONITOR assays for HIV and HCV outside of the United States in 1995. The HIV-1 assay was FDA approved in 1996; the HCV assay was not cleared until 2001. The HCV and HIV assays were cleared for use on the COBAS® AMPLICOR instrumentation in 2001 and 2005, respectively.

In 2005, Roche launched its next generation platform, the AmpliPrep/COBAS® TaqMan®, outside the United States. This platform was designed for automated sample preparation, amplification, and quantitation of HIV, HBV, and HCV. FDA approval was obtained for HIV in 2007; HCV and HBV followed in 2008.

Bayer Versant utilized branched chain DNA (bDNA) technologies for its assays. Their HIV viral load assay obtained FDA approval in 2002; both HBV and HCV received approval by 2003.

Although by 2005, molecular diagnostics had begun to find its way into the routines of clinical diagnostic laboratories, for the most part, areas of testing were confined to specific applications that had been well developed and were available in FDA approved formats: sexually transmitted diseases, hepatitis testing, HIV monitoring, and in some labs, Mycobacterium detection and/or identification.

Until this point, for other more easily maintained, cultivated, and identified pathogens, molecular methods, if available, had not found broad based acceptance and utilization.