Calypte Biomedical Corporation, 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 the Government of Kenya has stated that Calypte's urine testing is approved for importation, allowing Calypte the rights to distribute their urine based HIV-1 antibody tests and Western blot supplemental test into that Republic. The approval letter received by Calypte Biomedical was signed by Dr. Jack Nyamongo, Director of the Kenyan National Laboratory.
The National Aids Control Programme (NASCOP) of the Kenyan Ministry of Health formally met yesterday and announced that urine based HIV/AIDS testing, developed by Calypte Biomedical, is approved for distribution in Kenya. After extensive testing, NASCOP concluded that urine testing is a viable and safe method of testing for HIV. Dr. Achala Ndinya, Senior HIV Co-Investigator in Kenya stated that "Calypte's urine test's sensitivity and specificity was very impressive in all 4 testing centers around the country, equaling the results of their preferred blood test." Dr. Ndinya also stated that he was "extremely pleased with the results and is looking forward to working with Calypte in the fight against HIV infection."
Calypte previously announced that they received a Letter of Intent from World Vision outlining a purchase of urine HIV tests. Subsequent to that announcement Calypte has learned that the procurement for AIDS related testing and treatment are required to be routed through government agencies not through humanitarian organizations. As a result the Letter of Intent announced on September 16th has been cancelled. The success of the October 15th meeting with Kenyan's Ministry of Health now allows Calypte to transact the sale of its HIV/AIDS tests directly with the appropriate government agencies of the African Republics.
Jay Oyakawa, President of Calypte Biomedical stated, "After a rigorous and thorough testing process in Kenya, we are very pleased by the results and the official approval. This builds upon recent successes in Uganda and China where Calypte's urine testing maintains its high efficacy. A recent article in the East African pointed out that possibly 30% of HIV infected Africans received the virus through needles (International Association of Safe Needle Technology in Geneva, Switzerland). These results prove that urine testing is the viable alternative to needles."