Calypte Completes China Clinical Trials
PR Newswire - October 08, 2003 09:52
HIV-1 Urine EIA Trial Results Submitted to State Drug Administration For Approval By Biologics Branch
ALAMEDA, Calif., Oct. 8 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CYPT), the developer and marketer of the only two FDA approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA approved serum HIV-1 antibody Western blot supplemental test, announced that it has submitted to the Chinese State Drug Administration (SDA) the results of its clinical trials.
The trials were performed in support of the Company's application for approval by the Biologics Branch of the SDA.
The trials were performed at four sites and generated urine HIV data on over 10,000 Chinese subjects at various levels of risk for HIV infection. The data, which are to be reviewed by the SDA, estimated the sensitivity of the urine test at 100%, and its specificity at 99.95%.
"These data support our application for SDA Biologics approval admirably, and we will be eagerly awaiting the SDA's response to the submission," said Dr. Richard George, Vice-President of Government Affairs at Calypte.
The urine HIV-1 EIA is already legally marketable in China due to its approval from the Medical Devices Branch of the SDA, but additional approval by the Biologics Branch makes the test more marketable to certain government testing institutions.
Tony Cataldo, Calypte's Executive Chairman commented, "We continue to demonstrate strong results on sensitivity and specificity in relationship to urine testing. The strength of our data is stimulating interest and requests from the international community in Calypte's products as the only HIV-1 urine test in the world."
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