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Monday, 07/23/2007 8:02:45 AM

Monday, July 23, 2007 8:02:45 AM

Post# of 14825
NEWS OUT - Calypte Reports Continued Positive Results of Aware(TM) HIV-1/2 Oral Fluid Rapid Test Evaluations at the 4th Annual AIDS Conference in Sydney, Australia
Monday July 23, 8:00 am ET

LAKE OSWEGO, Ore., July 23 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC - News), medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV) announced today the results, including positive cost and social implications, of a field evaluation of its Aware(TM) HIV-1/2 OMT (oral fluid) rapid test in Tanzania. The results of the evaluation are being presented this week in a poster at the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia. Posters are scientific research publications presented in a display form for broad audience viewing, and have the advantage of providing an opportunity for extensive interaction between conference attendees and the poster authors.

The field evaluation was conducted on 1,055 clients at the African Medical & Research Foundation ("AMREF") ANGAZA Voluntary Counseling and Testing ("VCT") centers in Tanzania, a Non-Government Organization ("NGO"). ANGAZA is one of AMREF's primary projects in Tanzania; its objectives are to increase access to quality counseling for VCT centers as an entry to a continuum of HIV/AIDS care and prevention and to establish community care support for HIV positive clients. Of the clients tested at the ANGAZA center, 12%, or 123 clients, tested positive for HIV. The poster reported that the accuracy of the Aware(TM) HIV-1/2 OMT test was 100%, better than that of a comparable rapid blood test. (Calypte's rapid blood test was not evaluated in this study.). The poster also concluded that the evaluation "yielded a significant reduction in the cost of testing."

Roger Gale, Calypte's Chairman and Chief Executive Officer, stated, "We believe that oral fluid testing using our Aware(TM) HIV-1/2 OMT test will become the standard of care in many settings based on its continued strong clinical results coupled with the social and cost advantages of oral fluid testing. Our internal research has determined that the overall cost of oral fluid testing is less than that of blood testing. Oral fluid testing permits a healthcare worker to educate a group of clients simultaneously rather than requiring the individual attention demanded by all blood tests due to the administration, and blood handling and disposal requirements of blood-based tests. This is a significant advantage in resource-constrained settings requiring high client throughput. There are no other costs required to perform an oral fluid test and oral fluid has the obvious advantages of safety for both the client and healthcare worker and no hazardous disposal issues."

"We look forward to continuing to work with important NGOs like AMREF in Tanzania and elsewhere. We plan to support AMREF in their efforts to validate other aspects of HIV oral fluid rapid testing," Mr. Gale continued.

Mr. David Ocheng, a Medical Laboratory Technologist and project manager of AMREF who coordinated the field evaluation at ANGAZA elaborated, "We questioned the over 1,000 clients in this study on whether they would prefer a blood test or an oral fluid test, and, although they had consented to both for this to be a valid study, over 76.7% responded that they would prefer the oral procedure. We expect to now follow this question with a formal study on acceptance and welcome Calypte's support for this project. We believe acceptance of oral fluid testing has important implications, as our ability to increase the testing rate will have a direct correlation with our ability to then treat and care for HIV positive individuals. Ultimately, this is the best alternative screening method to support efforts to control the epidemic -- a very important goal of all of us involved in Tanzania."

Professor Willy Urassa of Muhimbili University College of Health Sciences in Tanzania ("MUCHS"), the lead investigator of this field study, commented, "Our study concluded that the test is indeed more cost effective than a blood test. This is one of the elements that would influence policy and decision makers in considering alternative rapid testing methods in the country. The results of sensitivity and specificity cannot be overemphasized, but when one considers overall cost, safety and acceptance, what will be left is to educate the public on the existence of alternative rapid testing methods through proper Government channels."

"We see that in many settings oral fluid testing can and should become the test of choice," Professor Urassa concluded.

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