Calypte Biomedical Announces Successful Conclusion of Internal Trials
GlobeNewswire “Press Releases”
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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