Business Wire - Thursday March 11, 1999
According to the recent letter of agreement signed by all involved parties, the NCAIDS and the CAPM intend to use Calypte's urine HIV test in various HIV screening applications, including: STD clinics, pre-screening of blood bank donors, military personnel, pregnant women, children, marriage license applications and insurance applications. The NCAIDS and the CAPM will assist Calypte in contacting, and working with, the World Health Organization, United Nations AIDS and other national health agencies in neighboring Asian countries to introduce Calypte's urine HIV test to these areas.
"This recently signed letter of agreement is a critical step towards the distribution of our urine HIV test in China, a country with the world's largest population -- more than 1.3 billion," stated William Boeger, chairman and CEO of Calypte. "It paves the way for our establishing a significant market presence in China and is also a significant validation of our test for use by the developing world."
"Calypte's urine HIV test will be a great benefit to the Chinese health system and people," said Dr. Kean Wang, director of the NCAIDS and president of the CAPM. "The availability of this very accurate, non-invasive test for HIV will be significant in helping to control the spread of HIV and AIDS in China. To further ensure the extensive use of the urine HIV test throughout the country at relatively low cost, we have also agreed to establish a joint venture to manufacture the Calypte urine HIV test in China."
HIV and AIDS have become major public health issues in China. The Chinese government announced in June of 1998 that it had found citizens infected with HIV-1 in 30 of its 31 provinces.
"Because the urine test is particularly useful for field-testing programs, it will expand the reach of HIV testing from our health centers in cities to remote rural settings," said Dr. Yunzhen Cao, director of the Department of Clinical Virology at the NCAIDS, and coordinator of the initial urine HIV test evaluation. "Most people do not want to have their blood drawn, but virtually everyone will provide a urine specimen."
Dr. Cao added, "In most developing countries such as China, especially in rural areas, we have difficulty getting highly-trained personnel and the sterile blood drawing equipment needed to test blood, whereas a urine test could be an essential and much more easily administered tool in helping to control the epidemic."
Calypte's new distributor in China, Hua Ai Co., Ltd., will provide Calypte extensive assistance with obtaining the necessary product import license and conducting marketing activities, including training medical staffs from provincial hospitals throughout China. According to the distributor and the NCAIDS, these activities are anticipated to be completed before the end of this year.
In June 1998, the U.S. Food and Drug Administration approved the Calypte Biomedical urine HIV-1 Western blot test. The screening test had been approved previously by the FDA. The urine test detects the presence of antibodies to HIV-1 in urine samples. Clinical studies have shown the urine diagnostic test system to be a very accurate alternative to blood testing. Urine testing is also non-invasive, less costly, does not require sample storage or a trained health care worker for sample collection, and is safer because there are no risks of accidental needle sticks. Also, while urine contains antibodies to HIV, it does not contain the actual virus.
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding the scope and use of the Company's tests in China. Actual results may differ materially from the above forward-looking statements due to a number of important factors, and will be independent upon the Company's ability, directly or through third parties, to successfully manufacture and market the HIV-1 urine testing system and obtain import licensure and appropriate regulatory approvals in China. Factors which may impact the Company's success are discussed in the Company's most recent Form 10-Q and 10-K. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events that occur after the date hereof or to reflect the occurrence of unanticipated events.
Contact: Healy Communications Jason Sherman/David Schulte, 312/440-3900 or Calypte Biomedical John DiPietro, 510/749-5100
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