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
LAKE OSWEGO, Ore., July 23, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC), 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.
About Calypte Biomedical:
Calypte Biomedical Corporation (www.calypte.com) is a U.S.-based healthcare company focused on the development and commercialization of rapid testing products for sexually transmitted diseases such as the Aware(TM) HIV-1/2 OMT test that are suitable for use at the point of care and at home. Calypte believes there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December 31, 2006 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact:
Richard Brounstein Tim Clemensen
Executive Vice President Rubenstein Investor Relations
(971) 204-0282 (212) 843-9337
rbrounstein@calypte.com tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
Richard Brounstein, Executive Vice President of Calypte Biomedical Corporation,
+1-971-204-0282, rbrounstein@calypte.com; or Investor Relations, Tim Clemensen,
Rubenstein Investor Relations, +1-212-843-9337, tclemensen@rubensteinir.com, for
Calypte Biomedical Corporation
www.calypte.com
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Calypte Biomedical Announces Successful Conclusion of Internal Trials
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 www.globenewswire.com/newsroom/prs/?pkgid=8290
LAKE OSWEGO, Ore., July 23, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC), 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.
About Calypte Biomedical:
Calypte Biomedical Corporation (www.calypte.com) is a U.S.-based healthcare company focused on the development and commercialization of rapid testing products for sexually transmitted diseases such as the Aware(TM) HIV-1/2 OMT test that are suitable for use at the point of care and at home. Calypte believes there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December 31, 2006 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact:
Richard Brounstein Tim Clemensen
Executive Vice President Rubenstein Investor Relations
(971) 204-0282 (212) 843-9337
rbrounstein@calypte.com tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
Richard Brounstein, Executive Vice President of Calypte Biomedical Corporation,
+1-971-204-0282, rbrounstein@calypte.com; or Investor Relations, Tim Clemensen,
Rubenstein Investor Relations, +1-212-843-9337, tclemensen@rubensteinir.com, for
Calypte Biomedical Corporation
www.calypte.com
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melden Olly D: Biomedi 17.09.07 15:00 #3584
ups..der threat war ja lange nicht...genutzt..
warum geht es morgen aufwärts?..gibt es neue Infos? bewerteninteressant
witzig
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melden willmehr: weisst du mehr? 17.09.07 15:04 #3585
sagen uns auch mal wieso.
würde mich intressieren. bewerteninteressant
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melden Biomedi: KLAR, guckt in den anderen Calythread! 17.09.07 15:14 #3586
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melden OttomanRosen.: überzeugende NEWS zu Calypte 17:53 #3588
Calypte Biomedical Announces Successful Conclusion of Internal Trials
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 www.globenewswire.com/newsroom/prs/?pkgid=8290
