Calypte Biomedical
This article was originally published in The Gray Sheet
Executive Summary
Alliance with SA Scientific, Inc., will focus on development of a urine-based rapid HIV-1/2 antibody test. Offering results within 15 minutes, the test will be developed and manufactured at SA Scientific's San Antonio facilities; Calypte will manage clinical trials. International distribution is planned for 2002, and the companies are currently focusing efforts to meet FDA's minimum requirements of 98% sensitivity and specificity for a CBER PMA. Once approved, a negative test will eliminate a patient from suspicion, while a positive test will require confirmatory testing with Calypte's FDA-approved HIV-1 urine tests, with results in under three hours...