LAKE OSWEGO, Ore., July 11 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation , medical diagnostic tests manufacturer for the rapid detection of antibodies to the human immunodeficiency virus (HIV) announced today that it has received registration and marketing approval for its Aware(TM) HIV-1/2 OMT (oral fluid) rapid test in India from the Central Drugs Standard Control Organisation, commonly referred to as the Drug Control Authority of India (“DCAI”).
Roger Gale, Calypte’s Chairman and Chief Executive Officer, stated, “As has been highlighted in recent news reports, India is at the forefront in the fight against HIV/AIDS and we have seen strong interest in our oral fluid tests from both the Government and private sectors. A Calypte team has just returned from India where we have begun putting in place the infrastructure to access and build on this important business opportunity. We expect the market for HIV diagnostic testing in India to grow significantly in the next few years.”
Mr. Gale continued, “This DCAI approval is a significant milestone in the advancement of our business; a very exciting time for all of us at the Company. Once our non-invasive HIV diagnostic tests gain market acceptance, we anticipate significant growth in market share of such tests. In addition to creating a distribution network, we expect to establish both research and manufacturing operations in India. While we will initially enter the Indian market with our HIV-1/2 oral fluid rapid test, we are also considering introducing our Aware(TM) HIV-1/2 rapid tests using both blood and urine samples to complement the current oral fluid test. India is also a logical center for development of Calypte’s new products.”
About India:
India has a population of over 1.1 billion, second only to China. According to recently published 2006 estimates by the National AIDS Control Organization or NACO, supported by both UNAIDS and WHO, India has an estimated 2.5 million HIV infections, ranking third behind South Africa and Nigeria for the highest number of HIV/AIDS infected people. Mr. Naresh Dayal, Secretary Health and Chair of the National AIDS Control Board said, " ... we cannot be complacent. The steady and slow spread of the HIV infection is a worrying factor.”
The announcement of these new HIV estimates coincides with the launch of a 5-year, $2.8 billion AIDS campaign by the Government of India to prevent the spread of the virus among the country’s large under-25 population. Calypte believes that a simple and cost effective non-invasive rapid test is an ideal solution to safely and quickly identify HIV/AIDS patients for treatment and care in large-scale programs such at this.
About Calypte Biomedical:
Calypte Biomedical Corporation (http://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: Richard Brounstein, Executive Vice President (971) 204-0282 email: rbrounstein@calypte.com Investor Relations Contact: Tim Clemensen, Rubenstein Investor Relations (212) 843-9337 email: tclemensen@rubensteinir.com
Calypte Biomedical Corporation
CONTACT: Richard Brounstein, Executive Vice President, of CalypteBiomedical Corporation, +1-971-204-0282, or rbrounstein@calypte.com;Investor Relations, Tim Clemensen, +1-212-843-9337, ortclemensen@rubensteinir.com, for Calypte Biomedical Corporation
Web site: http://www.calypte.com/
