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Calypte's oral HIV test:

This article was originally published in Clinica

Executive Summary

The Chinese state Food and Drug Administration (SFDA) has approved Calypte Biomedical's Aware HIV-1/2-OMT rapid oral HIV test. It is the first and only rapid oral fluid HIV diagnostic in the country, the Portland, Oregon-based company claimed. The product will be manufactured and sold by the firm's Chinese subsidiary, Beijing Marr Bio-Pharmaceutical. Calypte said it was "thrilled" with the long-awaited approval - it had originally hoped for a response from the Chinese FDA in mid-2005. HIV incidence in China is rising rapidly, and is expected to reach 15 million by 2010, the firm said. Aware was also approved in India in July 2007 (see Clinica No 1265, p 16).

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