Calypte Receives South African Approval for Aware(TM) Oral Fluid HIV-1/2 Rapid Test
LAKE OSWEGO, Ore., April 24 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) (the "Company"), today announced the completion of clinical studies in South Africa which permit the Company to initiate sales of its Aware(TM) HIV-1/2 Oral Fluid (OMT) rapid test product in the country. This is a new approval for OMT in addition to the Company's already-approved blood test.
Studies conducted by the University of KwaZulu-Natal in Durban, South Africa on the Aware(TM) HIV-1/2 OMT rapid test for oral fluid specimens showed sensitivity of 99.62% and specificity of 100% for a total of 600 subjects attending voluntary counseling and testing ("VCT") services in two Durban municipality clinics. The National Institute for Communicable Diseases (NICD) has issued a statement noting "that the design and execution of the study is in keeping with the standard approach used by the NICD reference lab to assess HIV-1/2 rapid kits for evaluation as part of the National Department of Health tender procedures." Therefore, "the results of the study are in keeping with the defined limits of acceptability and as such [the test] can be considered for tender purposes."
Mr. Charl Louw, Science Sales Executive and Mike Thompson, Key Account and Product Manager, Sub-Saharan Africa, at Adcock Ingram's Scientific Group (AIS), the distributor for Calypte's Aware(TM) HIV-1/2 OMT test in South Africa stated, "We are delighted that the Aware(TM) HIV-1/2 OMT rapid test has been recognized and evaluated in South Africa. This is generating a lot of interest around the country, such as in the VCT clinics, and across our borders. We foresee market growth within this product portfolio shortly."
Mr. Roger Gale, Chairman and Chief Executive Officer of Calypte commented, "The conclusion of this clinical study allows the Company to market oral fluid rapid tests within the private markets in South Africa and to participate in government tenders as they are announced. AIS's 22 years of serving the South African clinical markets makes them an ideal partner to introduce Calypte's new non-invasive HIV-1/2 oral fluid test that we believe is ideally suited for the South African market."
About Adcock Ingram:
Adcock Ingram's Critical Care division owns 74% of AIS, a full service distributor with 150 employees focused on the clinical as well as the medical and hospital markets in South Africa. AIS has been involved with rapid tests, the HIV test in particular, over the past three years. AIS also has a track record of success in national tenders.
About South Africa:
According to the UNAIDS December 2005 epidemic update, "infection levels in Sub-Saharan Africa remain among the highest in the world." The latest data underline the astonishing speed "at which South Africa's epidemic has evolved." National prevalence grew from less than 1% in 1990 to almost 25% in 10 years. Deaths among people 15 years of age and older increased by 62% from 1997 - 2002. And, according to the Department of Health South Africa, 2005, almost 30% of pregnant women are HIV-positive. [Statistics SA, 2005] UNAIDS discusses these statistics as underscoring "the need to bolster prevention activities." Calypte believes that a non-invasive HIV-1/2 rapid test is ideal for the fight against AIDS in South Africa.
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 such as the HIV-1 BED Incidence EIA and 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 there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing 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 for the year ended December 31, 2005 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact:
Theodore R Gwin, Tim Clemensen,
Chief Financial Officer Rubenstein Investor Relations
971-204-0282 212-843-9337
email: tgwin@calypte.com email: tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
-0- 04/24/2006
/CONTACT: Theodore R Gwin, Chief Financial Officer of Calypte Biomedical
Corporation, +1-971-204-0282, tgwin@calypte.com; or Tim Clemensen of
Rubenstein Investor Relations, +1-212-843-9337, tclemensen@rubensteinir.com,
for Calypte Biomedical Corporation/
/Web site: http://www.calypte.com /
(HIV)
CO: Calypte Biomedical Corporation
ST: Oregon, South Africa
IN: BIO MTC HEA IDC
SU: TRI
MV-KC
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3053 04/24/2006 07:30 EDT http://www.prnewswire.com
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