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Calypte Biomedical Corporation
15875 SW 72nd Ave
Portland, OR 97224
Tel: 503-726-2227
503-726-2227
Fax: 503-601-6299
Toll Free: 877-CALYPTE877-CALYPTE
BY ENHANCING KNOWLEDGE TODAY
In the fight against disease, knowledge is power – for individuals, communities and nations. To help in the battle, Calypte Biomedical Corporation develops innovative in vitro diagnostic testing solutions for HIV and other infectious diseases.
Our reliable, non-invasive HIV diagnostic tests and specialty research tools are helping doctors and scientists improve health and health care around the world.
CALYPTE BIOMEDICAL CORPORATION
Calypte Biomedical Corporation develops in vitro testing products to improve the diagnosis of Human Immunodeficiency Virus (HIV) infection, sexually transmitted diseases and other chronic diseases.Aware™ HIV-1/2 OMT is such type of product.Our innovative product line includes both point-of-care rapid tests and traditional EIA diagnostic tests.
Founded in 1988, Calypte is a pioneer in non-blood-based HIV antibody testing. We’re the first and only company to earn approval from the U.S. Food and Drug Administration for a urine-based HIV-1 antibody-screening test and supplemental Western blot.Today, our Aware™ family of rapid oral fluid HIV tests offers unrivalled HIV 1/2 testing flexibility in a non-laboratory setting.
Calypte is also the licensed manufacturer of a quantitative enzyme immunoassay developed by the U.S. Centers for Disease Control and Prevention (CDC) that can discriminate between recent and established HIV-1 infections. Designed for use in epidemiology, the Aware™ BED™ EIA is a practical way to determine HIV-1 incidence (the rate of new infections). Because it uses cross-sectional rather than longitudinal sampling and is based on direct biomarker evaluation, the BED EIA can provide incidence information much more rapidly than traditional methods such as cohort studies. Since its introduction in 2004 (formerly under the name BED HIV-1 Incidence EIA), the Aware™ BED™ EIA has gained widespread favor with government institutions and HIV intervention programs worldwide as a tool for better allocating resources, measuring program success and targeting HIV hot spots.
Working through a network of national and regional distributors Calypte continues to broaden the reach of its products. We plan to launch a new line of rapid HIV antibody tests in the United States and other developed nations using a novel lateral flow platform technology and we remain committed to bringing new products to developing regions where the need is acute for accurate, innovative HIV testing methods.
To meet this demand with maximum quality and efficiency, we’ve added manufacturing capacity through a contract with an ISO-certified manufacturer in Thailand and a cGMP certified manufacturer in the USA.
Publicly held, Calypte trades on the OTCBB under the symbol “CBMC.”
Calypte Life Sciences offers innovative and unique products for improving the performance of immunoassays. Whether for rapid test or ELISA platforms, Calypte Life Sciences products improve immunoassays by strengthening signal, reducing background, and optimizing antigen-antibody binding. Calypte Life Sciences also offers highly purified recombinant proteins and antigens for a wide range of applications including HIV, Influenza, Dengue Fever, Hepatitis C and others.
Sampling Device
In the first quarter of 2008, we introduced our Aware TM Messenger TM oral fluid sample collection device. This collection device is based on the same principle as employed in our Aware TM HIV-1/2 OMT test. This product can be used to collect oral fluid analytes for not only HIV antibodies, but also for hepatitis antibodies, drugs of abuse and certain genetic screening applications, among others. Our initial target for this product is the life insurance risk assessment market.
Aids 2008 MEXICO
Key players in world HIV/AIDS testing market with significant presence include Abbott Laboratories Inc., Adaltis Inc., Siemens Healthcare Diagnostics Inc., Biomérieux SA, Bio-Rad Laboratories Inc., Calypte Biomedical Corporation, Celera Group, Gen-Probe Inc., Innogenetics NV, MedMira Laboratories, Inc., Medical Services International Inc., OraSure Technologies Inc., Ortho-Clinical Diagnostics Inc., and Roche Diagnostics. In the rapid testing market, key participants comprise Orasure, Trinity Biotech, Calypte Biomedical Corporation, Medical Services International Inc., and MedMira. OraSure Technologies, Inc. leads the market for oral fluid diagnostics worldwide.
www.understanding-hiv-aids.com/a390073-hiv-aids-testing-market-to-exceed-3-9.cfm
Effective in January 2006, Calypte became the 51% owner of Beijing Marr Bio-Pharmaceutical Co., Ltd. ("Beijing Marr"). We purchased our equity interest from Marr Technologies Asia Limited ("Marr Asia"), an affiliate of Marr. Marr Asia continues to own the remaining 49% interest in Beijing Marr. Through our acquisition of Beijing Marr, we have acquired rights to manufacturing facilities and other assets necessary to manufacture our AwareTM line of HIV-1/2 rapid test products in China. Beijing Marr is currently renovating the manufacturing facilities, completing the transfer of assets it purchased from Beijing Yaohua Bio-Technology Ltd. (the "Yaohua Assets") and obtaining the necessary governmental approvals to begin production of our AwareTM HIV-1/2 rapid oral fluid (OMT) diagnostic test, which is currently under evaluation by the Chinese State Food and Drug Administration ("SFDA"). (10KSB)
ccn.mofcom.gov.cn/356515
Huairou district is located in northeast of Beijing with a distance of 50 kilometers from the city area. It is 32 kilometers from the Beijing International Airport, and 170 kilometers from Tianjin Harbor. To its north is Yanshan Mountains and to the south is North China Plain covering an area of 2128.74 square kilometers with a population of 270,000. Beijing Yaohua Bio-Technology Ltd is located in Huairou district with annual sales more than 100 million Yan ($12 Million Dollar). In May 2005, Beijing Marr Bio-Pharmaceutical Co., Ltd. was incorporated in Huairou district. In December 2005, Beijing Marr Bio-Pharmaceutical Co bought Beijing Yaohua Bio-Technology Ltd. In January 2006, Calypte became the 51% owner of Beijing Marr Bio-Pharmaceutical Co., Ltd.
Calypte has approvals in the following countries:
Uganda
May 16, 2005
Test(s) Approved: Aware® BSP, OMT
Population: 26 million
Infected: 530,000
Number tested in 2004: 1 million
Zimbabwe
September 15, 2005
Test(s) Approved: Aware® BSP
Population: 13 million
Infected: 1.8 million
Malaysia
October 11, 2005
Test(s) approved: Aware® BSP
Population: 24 million
Infected: 55,000
United Arab Emirates
January 19, 2006
Test(s) Approved: Aware® OMT OTC
First OTC Rapid HIV Test in the world
No. of Countries: 22 Middle East
Population: 465 Million
Infected: 230,000 to 1.5 million
Kenya
March 28, 2006
Test(s) Approved: Aware® BSP, OMT
Population: 30 million
Infected: 1.2 million
South Africa
April 24, 2006
Test(s) Approved: Aware® BSP, OMT
Population: 44,187,637
Infected: 6.29 million
USAID Waiver List
Test(s) Approved: Aware® BSP, OMT HIV-1/2
www.usaid.gov/our_work/global_health/aids/TechAreas/scms/scms.html
Company Information view SEC File
http://www.wopular.com/newsracks/calypte+biomedical+corp
hivaz.cn/aizibingshizhi/post/42.html
Google Search Calypte - AWARE OMT in China :
2011: MarrBio and Pharmaceutical Group Humanwell depth cooperation, Humanwell Pharmaceutical Group to become a strategic investor MarrBio organisms, biological and Shimano combination Humanwell Medical Group, will open a new Chinese HIV saliva test reagent market chapter.
MarrBio always adhering to the "quality of life, precisely from responsibility" concept, has passed the ISO13485, ISO9001 international quality system certification. MarrBio organisms with first-class team of scientists, chief scientist of the U.S. presence, the appointment of senior long-term production experts and American scientists regularly scheduled staff training; Marr biological carefully selected leading international business as a supplier of raw materials from the world's leading laboratory Preparation; Marr biological quality assurance throughout the entire production process, including audit suppliers, raw materials procurement, purchase of materials distributed storage, intermediates and all aspects of the preparation of semi-finished and finished products factory, etc., to achieve the whole process of production checks.
MarrBio is committed to the cause of China's AIDS Prevention, CDC-oriented VCT clinics, hospitals, NGO organizations and HIV risk groups, in order to quality products and personalized service, to provide users with non-invasive and painless, safer, more intimate, Faster, accurate HIV testing experience. Future medical conditions and for a limited blood difficult areas, specific populations difficult interventions, aware Ai Wei products will take further advantage of the implementation of corporate social responsibility, responsiveness and support the Chinese government "to expand the coverage of surveillance and testing to maximize discovery of HIV infection who "policy for China to make a positive contribution to the cause of AIDS!
Calypte Biomedical company founded in 1988, has become the market of non-invasive detection of HIV antibodies in the field of pioneers. In order to HIV1 / 2 antibody test non-laboratory environments provide a traditional blood test reagents do not have the flexibility, including the Portland-based company launched Pood urine, oral mucosal exudate, blood samples for HIV testing reagents its Western blotting detection reagent is the nation's first FDA-approved similar products. Aware™ HIV-1/2 has been carried out on a global scale clinical trials over 8600 cases, experiments show that the accuracy Aware™ HIV-1/2 reached 99.8%, the accuracy and rapid blood test reagent is quite excellent.
Humanwell Pharmaceutical Group was established in 1993, in 1997 and listed on the Shanghai Stock Exchange. After nearly 20 years of development, human welfare medicine has become integrated pharmaceutical group, under the jurisdiction of more than 10 pharmaceutical companies and a number of pharmaceutical commercial enterprises, has become China's pharmaceutical industry hundred enterprises, state-level enterprise technical centers, has been anesthetic in the country, the field of fertility regulation medicine, Uygur medicine has established a leadership position. As a "National Enterprise Technology Center", "National Key New Drug Creation of special commitment units", the company adhere to the research and development for the pilot, ongoing R & D investment, with the famous research institutions have established close ties and cooperation platform, and with the Chinese military Academy of Medical Sciences established the "Optics Valley of Military Sciences innovative drug research and development center."
http://www.marrbio.com/about/about.html
-NEWS-
http://www.marrbio.com/news//2013/1106/255.html
http://www.marrbio.com/news//2013/0626/181.html
http://www.marrbio.com/news//2013/0603/172.html
http://www.marrbio.com/news//2013/0506/161.html
http://www.marrbio.com/news//2013/0104/103.html
http://www.marrbio.com/news//2012/1213/92.html
http://www.marrbio.com/news//2014/0125/320.html
www.summer-creative.com/assets/summer_creds_winter_09.pdf
This message board is used by Calypte stockholders and anyone who would like to make comments, ask questions or provide information related to the stock. If you are new to this board we welcome you and look forward to civil discussions. Any message using profanity, racial slurs or personal attacks will be removed. Please do not give personal information on this board, if you wish to do so please use the "Private Reply" button located in the top of each message screen.
*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
for OTC sales
