PORTLAND, Ore., March 2, 2011 (GLOBE NEWSWIRE) -- Calypte Biomedical Corporation (OTCBB:CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, today announced successful completion of internal studies of its new Aware HIV-1/2 oral fluid rapid test for the US and international markets.
"I am pleased that Calypte's new Aware HIV-1/2 rapid test has been successful in these studies. We strongly believe that our product has the potential to significantly improve HIV testing and early diagnosis," said Adel Karas, Chairman and CEO of Calypte.
The trials were performed at two sites – one in South Africa and one in the US – and generated data from 577 subjects at various levels of risk for HIV infection. In combined results, Calypte's new Aware HIV-1/2 oral fluid rapid test showed an accuracy of 100%.
"We believe that we have a test that performs as well as any other HIV-1/2 oral fluid test in the market," said Richard George, former CEO of Calypte, who is currently a scientific advisor to the company.
Based on these promising results, Calypte has contacted the FDA and started the process to conduct clinical trials in the second half of 2011.
About Calypte Biomedical Corporation:
Calypte Biomedical Corporation develops in vitro testing products to improve the diagnosis of Human Immunodeficiency Virus (HIV) infection and other sexually transmitted and chronic diseases. Calypte's product line includes both point-of-care rapid tests and an EIA based incidence test.
Founded in 1988, Calypte is a pioneer in non-blood-based HIV antibody testing. Calypte is the only company to have earned FDA approval for a urine-based HIV-1 antibody-screening test and supplemental Western blot. Today, Calypte's Aware™ family of rapid oral fluid and blood based HIV tests offers flexible testing of HIV 1 and HIV 2 in a non-laboratory setting.
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Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by managements. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 related to our ability to commercialize our products, our ability to obtain sufficient financing, and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
Development of new products is inherently uncertain, and there can be no guarantee that any particular product candidate will become a commercial product or will be successful in the marketplace. The length of time it takes for us to complete clinical trials and obtain regulatory approval for product marketing may vary significantly, and the success of our internal trials does not guarantee that we will ultimately obtain FDA approval to sell our product commercially. During recent periods we have experienced significant constraints on our cash resources and have funded our operations through periodic equity investments on the part of a limited number of existing stockholders; there is no assurance that these sources of financing will remain available to us in future periods, and if we lose access to such financing, we may be unable to complete our planned clinical trials or to commercialize and manufacture our product.