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Biotech Law Weekly

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Calypte Biomedical Corp.



Rapid HIV blood test passes Malaysian government evaluation



November 4th, 2005

Calypte Biomedical Corp. (HIV) has received notification that Aware BSP, its rapid blood test for HIV-1 and HIV-2 antibodies, has been successfully evaluated by government agencies in Malaysia.

In Malaysia, favorable government evaluation is generally requested although not strictly required to market HIV tests.

Aware BSP is a 20-minute rapid test designed to detect HIV antibodies in whole blood, serum, or plasma. It is one test in a line of three such assays, the other two being designed to detect HIV antibodies in oral fluid and urine. The health authorities in Malaysia have not evaluated non-blood HIV tests in the past, and are determining how...


Source: Biotech Law Weekly (2005-11-04)

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