Calypte Biomedical Announces Successful Conclusion of Internal Trials
March 02 2011 - 6:57PM
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.
The Calypte Biomedical Corporation logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8290
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.
CONTACT: Media Contact: Angela Baker
Office: 503.726.2227
Email: abaker@calypte.com