posted
This is going to be hugh in the next few weeks after approval is got for first product.........
HIV.ob
Calypte Biomedical Receives Final Report From China Clinical Trials Tuesday September 6, 9:25 am ET
LAKE OSWEGO, Ore., Sept. 6 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV - News) today announced that it has received the final clinical trial report from the Chinese Centers for Disease Control (Chinese CDC) confirming the performance of the five Calypte HIV tests that were evaluated earlier this year. Three rapid HIV tests, Aware HIV-1/2 BSP, Aware HIV-1/2 OMT, and Aware HIV-1/2 U were evaluated in these studies. These tests employ, respectively, blood, oral fluid, and urine samples. In addition, the Calypte HIV-1 Serum Western blot and the HIV-1 Urine Western blot tests were evaluated for their performance in various Chinese provinces and populations. The clinical trial was performed by the Chinese CDC. The clinical trial of the three rapid tests included 1506 subjects; 247 of whom were infected and 1259 of whom were uninfected. The table below summarizes the performance of the rapid tests.
Sensitivity is a measure of the number of infected subjects correctly identified as positive. Specificity is a measure of the number of uninfected subjects correctly identified as negative. Accuracy is a composite measure of how many of the test subjects were correctly classified as infected or uninfected.
The serum and the urine HIV-1 Western blots also performed well, with sensitivities of 100% and 98.4%, respectively. The specificity of the urine Western blot was 100% and the specificity of the serum Western blot was 99.4%. The specificity of the serum Western blot was less than 100% as a result of two HIV-negative subjects whose sera displayed bands for p24, resulting in a so-called "indeterminate" interpretation. The presence of p24 antibodies is a common occurrence in uninfected individuals, and indeterminate results should not be confused with false positive results.
Dr. Richard George, President and CEO of Calypte said, "We are extremely encouraged by the excellent outcome of the China clinical trial. The Chinese CDC did an admirable job of conducting these studies and preparing the report. We now believe that all three rapid assays are approvable and that the OMT and urine tests are eligible for accelerated review. As I stated in our most recent conference call on August 15, the first application we file will be for approval of the Aware HIV-1/2 OMT test. We expect to make the submission in the coming weeks. The OMT application will be followed shortly by a submission for the Aware HIV-1/2 Urine test."
Dr. George continued; "Work in China continues at a vigorous pace to prepare for the impending launch of our sales effort after receipt of SFDA approval. Dr. Ron Mink, Calypte's Chief Science Officer, and members of his scientific staff are currently at our manufacturing facility near Beijing training our staff to make the rapid assays. We are also expecting delivery and installation of automated manufacturing equipment in early September. It is very gratifying to see all of our hard work resulting in a successful conclusion."
About China:
China has a population of approximately 1.4 billion. According to a joint China, World Health Organization and UNAIDS epidemiological survey there were 840,000 adults and children in China living with HIV/AIDS in 2003. In July of 2004, the Chinese premier, Wen Jiaboa went so far as to acknowledge HIV/AIDS as one of the "serious problems" facing China. Some experts have predicted that the number of infections by that date might exceed 15 million. Most experts agree that testing and education are the most important things that can be done to stem the spread of HIV/AIDS. To that end, the Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. In countries where HIV infection has been contained, according to UNAIDS estimates, annual testing rates of the population aged 15-64 that is tested in a non-blood bank setting is between 15% and 25%. To effectively combat the spread of infection and meet the goals they have set for themselves, we believe that China must bring testing rates up to these levels and that this can only be done by the use of simple, inexpensive, and safe tests that can be performed on non-blood samples such as oral fluid and urine. Such tests can be performed in large numbers by non-medical personnel in all types of non-traditional settings.
About Calypte Biomedical:
Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed 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/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.
posted
I don't know who you are stranger but you called this one right. I got in at .20. This could be a nice ride. I'd been watching it earlier. We'll see where it goes.
posted
Hey, bad news is....they just joined the amex 8-16-2005. Most stocks that come out of pinks get raped. I would sit back and look for a dip before I bought any. I think the news is good.....but its not like the tests are going to be available anytime soon. They always have to get approvals for public sale. So on that token....it might be a while before we see this one take off....long term....Your make lots of money. Short term....not likely.
Posts: 2367 | From: Detroit | Registered: Mar 2005
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posted
actually, they joined the Amex 8-18-2004. the 05 headline was for continued listing.
Posts: 1045 | From: novato,ca,usa | Registered: Aug 2003
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quote:Originally posted by metal1: actually, they joined the Amex 8-18-2004. the 05 headline was for continued listing.
Ok....but does 2 days really matter. I was just looking at the news when I got the date.
Posts: 2367 | From: Detroit | Registered: Mar 2005
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posted
They will make a submission in the coming weeks.
Might not take to long to get approval in China...
The product is packed and ready to ship apparently.
Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population.
Posts: 115 | From: Ireland | Registered: Jan 2005
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Item 1.01 Entry into a Material Definitive Contract. Effective on September 1, 2005, Calypte Biomedical Corporation ("the Company") entered into an agreement (the "Agreement") with Marr Technologies Asia Limited ("Marr"), a Seychelles company, to define the respective rights, duties and obligations of the parties in connection with the ownership and operation of Beijing Calypte Biomedical Technology Ltd. ("Beijing Calypte"), a joint venture entity created in the Peoples' Republic of China ("China") to manufacture, market, distribute and sell certain of the Company's current and future products in China. Marr is an affiliate of Marr Technologies BV, a Netherlands company, which currently owns approximately 27% of the Company's outstanding common stock.
The Agreement authorizes a five-member Board of Directors which is responsible to manage the business, property and affairs of Beijing Calypte in accordance with the provisions of the Agreement, Beijing Calypte's Amended and Restated Articles of Association and all applicable laws. The Board is composed of three directors designated and appointed by Calypte, each for a four year term, and two directors designated and appointed by Marr, each for a four year term. Each Director shall cast one vote on each resolution to be voted upon. The Agreement further specifies certain major decisions, such as incurring indebtedness, merging Beijing Calypte with another entity, acquiring another entity or dissolving Beijing Calypte, among others, which require unanimous vote by the Board of Directors.
The Agreement provides, with only limited exceptions, that neither Marr nor the Company has the right to transfer its interest in Beijing Calypte to any other entity. The Agreement will remain effective until it is terminated upon the mutual agreement of Marr and the Company or upon a resolution of the Board of Directors of Beijing Calypte or an order by a court of competent jurisdiction for the winding down of Beijing Calypte's business affairs.
Posts: 115 | From: Ireland | Registered: Jan 2005
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posted
Topcat, This one looks primed for long term swing plays. Everyone should make alot of money. I'm in at .20 so I'm up 40% at close yesterday. And, It's at .29 after hours.
posted
HI GUYS. I'M A NEW INVESTOR AND JUMPED HEAD FIRST INTO CALYPTE,(HIV). I BOUGHT 364,672 SHARES. SOME AT .28 AND THE REST AS I COULD AQUIRE YESTERDAY, 9-12-05. THIS THING IS GOING TO MAKE A TON OF MONEY! I'VE RESEARCHED EVERY SEARCH ENGINE I COULD FIND AND THE WORD IS: 66% INCREASE BY YEARS END, DEC.2005, UP 200% YEAR END 2006. 60-90 DAYS FOR THE APPROVAL PROCESS SFDA(CHINA), WAITING FOR APPROVAL FROM OUR FDA, EST.120 DAYS. BASICALLY WE'LL HAVE A MONOPOLY IN THE CHINESE MARKET. THE CHINES GOVERNMENT HAS A SFDA APPROVED PLANT UP AND RUNNING MAKING THE TEST KITS,NOW! ORDERS FROM THE 3rd WORLD COUNTRIES ARE ARRIVING. ROCKADLE MARYLAND PLANT APPROVED AND UP AND RUNNING, PRODUCING KITS, NOW! THE PLANT ITSELF HAS BEEN SOLD TO ANOTHER COMPANY, REDUCING OVERHEAD AND COSTS BIG TIME! NEW MANAGMENT, RESTRUCTURED PLAN, REDUCED OVERHEAD, AND A VIRTUAL MONOPOLY IN CHINA. YOU'RE GOIN' TO MAKE A FORTUNE,IF YOU ARE PATIENT. TO ME, THIS IS A ONCE IN A LIFETIME OPPORTUNITY. I HAVE RESEARCHED THIS COMPANY UP AND DOWN. IT'S JUST GOING TO TAKE A LITTLE TIME. THIS STOCK HAS ALL THE POTENTIAL TO HIT $5.00 IN A YEAR, YEAR AND A HALF. IN MY HUMBLE OPINION.
Posts: 2 | From: illinois | Registered: Sep 2005
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posted
I NEED ALL THE FEEDBACK I CAN GET. THIS COMAPNY IS NOT THE OLD CALYPTE, IT IS COMPLETELY RESTRUCTED. AND HAS AND UNUSUALLY GOOD RELATIONSHIP WITH CHINA. THIS MAY BE THE BIG ONE.
Posts: 2 | From: illinois | Registered: Sep 2005
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posted
Topcat, it appears we have settled within a narrow range and established a new floor. The initial day traders have taken their profits. Let's wait on the next PR. Good luck
posted
Big news.... HIV-1/2 BSP Test Receives Zimbabwe Approval. Up 25+% in premarket
Posts: 11304 | From: Fort Worth, Texas | Registered: Mar 2005
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Aware(TM) HIV-1/2 BSP Test Receives Zimbabwe Approval Thursday September 15, 8:41 am ET Regulatory Trials Of Aware(TM) BSP Generate 100% Accuracy
LAKE OSWEGO, Ore., Sept. 15 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV - News) today announced that the Medical Laboratory & Clinical Scientists Council of Zimbabwe has issued notification that the Calypte Aware(TM) HIV-1/2 BSP rapid (blood) test has been successfully evaluated and cleared for commercial sale in Zimbabwe. The Calypte Aware HIV-1/2 BSP rapid test was evaluated under the direction of the Medical Laboratory & Clinical Scientists Council of Zimbabwe on over 1,000 samples. Roughly half of the samples were archived samples from the national reference panel and the other half were collected prospectively from clinical patients, blood donors, and attendees at VCT (Voluntary testing and Counseling) sites. The clinical trial of the Aware HIV-1/2 BSP rapid test included 1,005 subjects; 224 of whom were infected and 781 of whom were uninfected. The table below summarizes the performance of the rapid tests.
Sensitivity is a measure of the number of infected subjects correctly identified as positive. Specificity is a measure of the number of uninfected subjects correctly identified as negative. Accuracy is a composite measure of how many of the test subjects were correctly classified as infected or uninfected.
Calypte and its distributor, National Diagnostics, are now working with authorities on a process by which Aware HIV-1/2 OMT (oral fluid) and HIV-1/2 U (urine) rapid assays can be evaluated. Zimbabwe has not had the opportunity to field test non-blood HIV screening tests before, and its standard approach to evaluate HIV antibody tests is not appropriate for samples such as urine and oral fluid. The authorities are examining various proposals for such an evaluation.
Dr. Richard George, President and CEO of Calypte said, "We are delighted that the BSP test has passed yet another regulatory hurdle, and we now look forward to working with National Diagnostics, our distributor in Zimbabwe, to get the product commercially launched. In parallel we hope to complete the evaluation using the Company's technology in Urine and Oral fluid."
Tony Mariani, President of National Diagnostics, added, "We are extremely pleased with the exceptional results achieved by the Aware BSP HIV-1/2 kit in its evaluation phases. We look forward to our venture with Calypte in the marketing and distribution of this kit throughout Zimbabwe. Since our establishment in 1991, National Diagnostics has imported and distributed a wide range of diagnostic reagents, and this project promises to be one of the most important undertakings in our company's history".
Zimbabwe, with a population of just under 13 million, has an estimated 1.8 million HIV infections, according to the UNAIDS 2004 Report on the Global AIDS Epidemic, ranking as the 3rd largest prevalence in Africa today.
Aware(TM) BSP is a twenty-minute rapid test designed to detect HIV antibodies in whole blood, serum, or plasma. It is one test in a line of three such assays, the other two being designed to detect HIV antibodies in oral fluid and uri
Posts: 115 | From: Ireland | Registered: Jan 2005
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I don't know who you are stranger but you called this one right. I got in at .20. This could be a nice ride. I'd been watching it earlier. We'll see where it goes.![[Cool]](cool.gif)
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