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FDA to review Roche's COBAS HIV test:

This article was originally published in Clinica

Executive Summary

Roche Molecular Systems says that the US FDA has agreed to review the company's PMA supplement for its Cobas Amplicor HIV-1 Monitor test (version 1.5). The automated, PCR-based test can measure levels of HIV-1 RNA down to as few as 50 copies/mL of plasma. The test was designed to address the growing need to identify variations in the group M subtypes of HIV-1 RNA. The Pleasanton, California company CE-marked the device for sale in Europe in 1999.

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