Calypte's Aware(TM) Rapid HIV-1/2 Tests Receive Approval in the Republic of Kenya
PR Newswire - March 28, 2006 08:30
LAKE OSWEGO, Ore., March 28, 2006 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (Amex: HIV) announced today the Kenyan National Public Health Laboratory Services (NPHLS) has issued notification of registration and approval for the Calypte Aware(TM) HIV-1/2 BSP (blood) and Aware(TM) HIV-1/2 OMT (oral fluid) rapid tests in the Republic of Kenya.
The registration and approval follows a formal evaluation of the products by The National AIDS Control Programme (NASCOP) of the Kenyan Ministry of Health. NASCOP recently completed a formal evaluation of the tests and found them to "meet the requirements for sensitivity and specificity for HIV test kits in Kenya." The kits are "certified for testing [sale] in Kenya."
E. M. Kiragu, Director of UltraLab and Allied Services, our distributor for Kenya said, "We are delighted that the Aware(TM) HIV-1/2 assays for blood and for oral fluid have now been registered here in Kenya and are available for sale. The oral fluid assay particularly has generated tremendous interest."
Roger Gale, Chairman and Chief Executive Officer stated, "With this announcement Calypte continues to expand the breadth of countries where we can market our rapid HIV-1/2 diagnostic tests. Kenya is an important milestone as a key country in the fight against AIDS in sub-Saharan Africa. Further, the positive clinical result from Kenya adds an important base to our worldwide clinical results, building to our planned upcoming application to the USAID Waiver list. In addition to enabling these products to compete for Kenyan government tenders expected to exceed over 4 million tests when announced later this year, our distributor has already contacted several NGOs who can buy these products directly now that they are registered. I look forward to updating investors on all of our progress in the past months in the coming days. We expect to file our 10KSB around the end of the month and will announce a conference call to discuss those results at the same time."