Calypte Only Company with Full Menu of Tests.

dringend benötigten Bekanntheitsgrad verhelfen. Die HIV-Tests des
Unternehmens sind Studien zufolge anderen, bereits vermarkteten, Tests
zwar überlegen, doch an der Nachfrage scheiterte bisher der Erfolg des
kleinen Unternehmens. Weshalb dies Calypte bisher nicht gelang lässt sich
nicht erklären, vielleicht aber ist es ja der schlechte Ruf des ehemaligen
CEOs, der Calypte einfach nicht auf die Beine kommen lässt.
Ein Studienprogramm, dass die von Calypte zum
Schnellnachweis von HIV-1/2 entwickelte Plattform Aware™
evaluieren soll, wird nun schon demnächst in Afrika starten. Die ersten
Versuche werden gemäß der Meldung im HIV-Referenzlabor des Virus
Research Institutes in Entebbe in der Republik Uganda beginnen. Die
Studie soll die Sensitivität, also die Empfindlichkeit, wie auch die
Genauigkeit, die als Spezifität bezeichnet wird, ermitteln. Als Testmaterial
werden Blut, Urin und Speichelproben von mit HIV-1 und HIV-2 infizierten
Patienten zum Einsatz kommen. Uganda zählt zu den Ländern Afrikas, die
am schlimmsten vom HI-Virus getroffen wurden. Gemäß der UNAIDS
waren 2003 rund 530.000 Menschen mit dem Virus infiziert. Im Jahr 2004
wurden etwa 100 Millionen Dollar für AIDS-Test und die Therapie von
AIDS von ausländischen Hilfsorganisationen nach Uganda transferiert.
Calypte will nun sein Testverfahren als Standardverfahren etablieren, was
mit dem erfolgreichen Verlauf der Studien sogar Realität werden könnte.
Die Studien, die unter Leitung des Direktors des Uganda Virus Research
Institutes, Dr. Benon Biryahwaho, durchgeführt werden, sollen rund 350
Infizierte einschließen. Das Studienprogramm repräsentiert das erste
staatlich überwachte Programm für das neue Schnelltestverfahren
Aware™ in Uganda. Bereits im zweiten Quartal dieses Jahres erwartet
Calypte die Ergebnisse der Studie, sollten diese den Wünschen
entsprechend ausfallen, dann will Calypte noch im ersten Halbjahr 2005
einen Zulassungsantrag für Aware™ in Uganda einreichen. Ein positiver
Entscheid würde Calypte die Marktführerschaft zumindest in Uganda
sichern. Für Calypte ist die Chance auf eine baldige Zulassung seines
Tests in Uganda ein wichtiger Meilenstein.
Wenn es nach Dr. Benon Biryahwaho geht, dann wird Aware™ auf alle
Fälle zum Standardtest für den Nachweis des AIDS-Erregers,
vorausgesetzt die Regierung Ugandas erteilt ihr okay. Der Mediziner
arbeitet schon seit längerem mit Calypte zusammen und ist begeistert
vom einfachen Handling der AIDS-Tests, die zudem einen schnellen
Nachweis des Erregers ermöglichen. Doch Uganda soll, wenn es nach
Calypte geht, erst der Anfang sein. 2005 sind weitere Studien mit
Aware™ in anderen afrikanischen Ländern, wie auch im Fernen
Osten, geplant. Auch die erste kommerzielle Applikation der
Technologie, die Calypte im Oktober 2004 von Ani Biotech erworben hat,
soll demnächst in klinischen Studien getestet werden. Den Anfang wird
ebenfalls der Mediziner aus Uganda machen, weitere Schlüsselmärkte
sollen noch in diesem Jahr folgen. Der Transfer der Ani Biotech
Technologie Plattform auf Calyptes HIV-Tests gelang schneller als
gedacht, so der neue Calypte-Boss Dr. George. Die Ani Technologie
erlaubt nicht nur die Herstellung von HIV-Tests für medizinisches
Personal, sondern ermöglicht auch die Herstellung von Tests, die sich für
den Hausgebrauch eignen. Die Letzteren sollen rezeptfrei erhältlich und
von Jedermann leicht zu handhaben sein.
Exakt hier schlummert ein nicht unerhebliches Potenzial, denn ein
rezeptfrei erhältlicher Test würde mit Sicherheit weit mehr Menschen zur
Testung animieren, als bisher. Oftmals ist es nämlich die Scheu vor einem
Arztbesuch, die Menschen von einem HIV-Test Abstand nehmen lässt. Die
Möglichkeit, Schnelltests für alle nur erdenklichen Virusinfektionen für den
Hausgebrauch zu entwickeln, sollte Investoren aufhorchen lassen. Wenn
Calypte dies gelingt, was mit der Ani Biotech Technologie möglich ist,
dann könnten die Penny Stock Zeiten für Calypte schon früher als gedacht
ein Ende haben. Noch etwas Geduld müssen die gebeutelten Anleger aber
haben, denn die Feuertaufe für den ersten HIV-Schnelltest steht noch
bevor.

www.BioTech-Experte.de


Die letzten Informationen zeigen uns das Sie kurz vor dem Ausbruch stehen..

Bitte ernsthafte überlegungen machen...

Gruß

C.O

Nigeria has a lot to learn from the execution sentence placed on Zheng. This country still has a long way to go in its professed disdain for corruption. Contempt for the rule of law in enforcing anti-graft laws has not abated. This development has injured public safety and also proved to be one of the reasons the country remains perpetually undeveloping. No country ingrained in corrupt practices ever develops. Nigeria will not be an exception.

The hurt Tafa Balogun, convicted former Inspector General of Police, did to the police force by stealing billions of Naira from its coffers cannot be less than what Zheng did in China. For all he did to undermine the police that is responsible for the nation's security, he spent less than six months in jail and he is now out enjoying his negotiated loot.

Offenders who committed lesser crimes are languishing in jail. This was a monumental example of how not to treat graft. All facets of national life must be rid of the graft menace and this could be done provided a non-status sparing approach akin to China's example is emulated by the government. There is more to learn from China by the government.

Our laws do not punish corruption with death, but the application of the existing laws is a huge joke. There are obvious indices of corruption. Where people are living above their means, without a reasonable explanation, where their tax payments are below the affluence they parade and in the cases where their spouses and children - usually without visible means of livelihood - are awash in opulence, corruption practices could account for these.

The political willingness to tackle corruption must include official practices that inhibit corruption. Are the wages paid in Nigeria able to sustain anyone? Who is supposed to cater for the millions who have been sidelined from existence through excruciating economic policies?

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

 

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 http://www.globenewswire.com/newsroom/prs/?pkgid=8290