Calypte's Aware(TM) Rapid HIV-1/2 Tests Receive Approval in the Republic of Kenya
LAKE OSWEGO, Ore., March 28 /PRNewswire-FirstCall/ -- 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."
About UltraLab and Allied Services:
UltraLab and Allied Services is a medical diagnostics company based in Nairobi, Kenya that distributes a portfolio of quality products for the detection of disease states.
About Kenya:
Kenya, located in sub-Saharan Africa, has a population of over 30 million according to the International Programs Center of the US Census Bureau. According to the UNAIDS 2004 report on the global AIDS epidemic, as of the end of 2003, Kenya has approximately 1.2 million HIV infected adults and children and 650,000 AIDS Orphans.
Under the direction of the U.S. Global AIDS Coordinator's Office, the HHS/CDC Global AIDS Program (GAP) is a partner in the unified U.S. Government effort to implement the President's Emergency Plan for AIDS Relief (PEPFAR). Kenya is one of 15 focus countries of PEPFAR, which collectively represent approximately 50% of the HIV infections worldwide. In 2006, the U.S. plans to provide over $200 million to support Kenya's fight against HIV/AIDS. Kenya now has over 350 registered VCT sites where Kenyans can receive counseling and testing; many of these supported by PEPFAR.
About Calypte Biomedical:
Calypte Biomedical Corporation is a U.S.-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.
Company Contact: Theodore R. Gwin, Chief Financial Officer Phone: (971) 204-0282 email: tgwin@calypte.com
Investor Relations Contact: Tim Clemensen, Rubenstein Investor Relations Phone: (212) 843-9337 email: tclemensen@rubensteinir.com SOURCE Calypte Biomedical Corporation -0- 03/28/2006 /CONTACT: Theodore R. Gwin, Chief Financial Officer of Calypte Biomedical Corporation, +1-971-204-0282, tgwin@calypte.com; or Investor Relations - Tim Clemensen, Rubenstein Investor Relations, +1-212-843-9337, tclemensen@rubensteinir.com / /Web site: http://www.calypte.com / (HIV)
CO: Calypte Biomedical Corporation; UltraLab and Allied Services; Kenyan National Public Health Laboratory Services; NPHLS; Kenyan Ministry of Health ST: Oregon, Kenya, Republic of Kenya IN: HEA MTC BIO SU:
WR -- NYTU075 -- 9633 03/28/200608:30 ESThttp://www.prnewswire.com |