Calypte's detour

Calypte Biomedical Corp. (CALY) last week reduced its work force by 40 percent four days after the FDA requested additional data on a component of CALY's urine screening assay for HIV-1. The agency said the data would be necessary before it would approve the use of Cambridge Biotech Corp.'s HIV-1 Western Blot Kit to confirm the results of the CALY assay.

"They requested data on additional population groups with certain disease states and certain demographic profiles, such as women in their second pregnancy," said President and CEO Jack Davis. The agency also asked CALY to modify the urine controls for use with CBCXQ's Western Blot Kit, which has been licensed and marketed for confirmation of reactive blood specimens for 10 years. ...