Calypte seeks to expand HIV-1 urine test sales in China:
This article was originally published in Clinica
Executive Summary
Calypte Biomedical is making progress with efforts to broaden the market for its HIV-1 urine test in China. The firm has submitted data from trials of the EIA-based test to the Chinese State Drug Administration (SDA) for approval by its biologics branch. The test is already approved in China via the medical devices branch of the SDA, but approval by the biologics branch makes it "more marketable to certain government testing institutions", says the Alameda, California firm. The latest trials generated urine HIV data on over 10,000 Chinese subjects. They estimated the sensitivity of the test at 100% and its specificity at 99.95%.