CALYPTE/CAMBRIDGE BIOTECH URINE-BASED HIV-1 CONFIRMATORY TEST NEEDS MORE DATA FOR STAND-ALONE USE, BPAC SAYS; CALYPTE AWAITS APPROVAL FOR SCREENING ASSAY
This article was originally published in The Gray Sheet
Executive Summary
Calypte Biomedical expects to be required to submit additional data in support of Cambridge Biotech's pending product licensing application supplement for use of its Western blot HIV-1 confirmatory assay with urine samples.