CBMC.OB

[kslifka]

CBMC....my kind of chart....up on positive test results on AIDS drug.

LAKE OSWEGO, Ore., July 16 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTCBB: CBMC - News), medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV) announced today the results and positive social implications of a field evaluation of its Aware(TM) HIV-1/2 OMT (oral fluid) rapid test in the Republic of South Africa . These results were recently presented in a poster at the 3rd South African AIDS Conference in Durban last month. Posters are scientific research papers (in poster presentation form) accepted by a conference for the education of its attendees, typically displayed in a Poster Section on the conference floor.

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The field evaluation was conducted on 600 clients of unknown HIV status at two busy Voluntary Counseling and Testing ("VCT") clinics in South Africa. The expected HIV prevalence rate was 30-40%; overall, 44% of the clients tested positive. The poster reported that "the results obtained on OMT were comparable with results on serum, and were statistically significant."

Study nurses responsible for the collection of samples described OMT (oral fluid test) collection as "easy to do", and preferred the non-invasive oral fluid collection method to the blood collection currently in use. Laboratory personnel found the test procedure simple to perform and results easy to interpret. "This assay may be a suitable alternative for VCT practices," was the poster's conclusion.

Roger Gale, Calypte's Chairman and Chief Executive Officer, stated, "We have long known the accuracy of the Aware(TM) HIV-1/2 oral fluid rapid test. The usage studies that are now being reported are focusing on the social aspects of such a test and we are pleased that there is strong sentiment for adopting oral fluid testing. While changing long-established blood collection practice to the OMT method is a process, we believe we are gaining momentum in making oral fluid an acceptable alternative to blood testing. The recent approval of our oral fluid test in India and the subsequent interest we are seeing from the government, military and private sectors is very encouraging in this regard."

Johannes Viljoen, MBChB, FC Path (SA) Viro, at the College of Health Sciences of the University of KwaZulu-Natal, Durban, South Africa and principal investigator presenting this poster noted, "We specialize with individuals living in rural settings of South Africa. In South Africa there are ongoing public health and media campaigns to increase public awareness and uptake of HIV testing in an attempt to curb the spread of the epidemic. We anticipate that offering a non-invasive rapid test may quite possibly result in an enhanced uptake of testing, mostly as a result of it being more acceptable and painless, even more so for children. In our study, the technique was clearly preferred over finger-sticks by the health care providers."

Dr. Pravi Moodley, Acting Head of the Department of Virology at the University of KwaZulu-Natal and National Health Laboratory Service, Durban, South Africa and a co-author of the poster commented, "The sampling of oral fluid for HIV antibody rapid testing in resource constrained settings has advantages over the conventional finger-prick blood which is currently used for HIV antibody rapid testing. The obtaining of an oral fluid sample is much simpler since a community health worker requiring minimal training will be able to obtain the sample. It is also much safer since no sharps and sharps containers are necessary, obviating the need for intensive health and safety training which may unnecessarily consume financial and human resources in already resource constrained settings."

Further, our field evaluation of Calypte's Aware(TM) HIV-1/2 OMT Rapid Test showed excellent correlation with blood samples," concluded Dr. Moodley.

[setravis]

Calypte CEO Discusses Chinese SFDA
Approval of Aware(TM) HIV-1/2 Oral Rapid Test
Shares of Calypte Biomedical Corporation (CBMC.OB) surged on heavy
volume Thursday after its Chinese subsidiary, Beijing Marr Bio-Pharmaceutical
Co. Ltd., received registration and marketing approval for
Calypte's Aware(TM) HIV-1/2 OMT (oral fluid) rapid test from the State
Food and Drug Administration ("SFDA") of China. This approval makes
the Aware(TM) HIV-1/2 OMT test the first and only SFDA approved
rapid oral fluid HIV test in China. Roger Gale, Calypte's Chairman and
CEO, stated in a conference call today, "This is the most significant
development for this company in the last five years. This approval bestows
credibility and prestige to the company and our product. It will
have an immediate positive effect on all of our marketing efforts and
ultimately add sales of products worldwide." "This approval also gives
us, for the first time, a very valuable approval in the country of manufacture.
Absence of this approval in the past has hampered our ability
to register and market the test in a number of countries, a hurdle we
can now overcome by producing the domestically approved Aware(TM)
product in our Chinese factory." "We have already begun the ramp-up
of our manufacturing, and we are in late-stage discussions with distributors
throughout China. We have also signed distribution agreements in
Russia and the Middle East." The Aware(TM) HIV-1/2 OMT test provides
diagnostic results in less than 20 minutes and, in previous studies,
has averaged 99.7% accuracy. AwareTM OMT testing is painless,
safe, and non-invasive. Samples can also be easily collected anywhere,
including public settings, giving the test a unique advantage over tests
using other sample media. Although more expensive than blood tests,
the all-in costs (including costs of handling and disposal of blood) are
less. Further, the Company expects the AwareTM OMT to have a cost
advantage over its primary current oral fluid competitor. Additionally, it
has a significantly longer shelf life than that of its primary competitor.
Mr. Gale explained, "We intend to narrow our focus in countries where
we have approval or expect to soon gain approval. Pursuits into new
countries will be halted or pushed back, with possible exceptions under
certain circumstances. We will seek the largest and least complicated
markets. We will also seek to enter the U.S. market as soon as possible.
We will continue to explore partnerships and commercial arrangements.
We are going to maintain an operating strategy that is flexible, dynamic
and ready for change." He added, "We are working hard to manage
our expenses, and our major warrant holders may agree to a monthly
or quarterly exercise program during 2008 if we can demonstrate a reduction
in monthly cash burn and overall improvement in financial performance.
The current fusion capital agreement may still be required
to supplement the warrant exercise program. We will also continue to
explore additional potential funding sources in April and May. Today's
news certainly will be helpful in these discussions."