Business Wire - Wednesday October 21, 1998
The coordinator of the urine test study/evaluation is Dr. Yunzhen Cao, Director of the Department of Clinical Virology, National Center for AIDS Prevention and Control. Dr. Cao returned to China last summer after serving initially as a staff scientist and a research associate professor at NYU, then research associate professor at Rockefeller University, and most recently as a senior research associate in the laboratory of Dr. David Ho, who heads The Aaron Diamond AIDS Research Center in New York City.
"The purpose of the study is to validate the accuracy of the Calypte HIV assay using Chinese patient samples," said Dr. Cao. "The urine test could be a critically important tool in helping to stop the spread of HIV/AIDS in China. We hope to potentially use the urine test to help China get a better handle on the epidemic. I had personal experience with the Calypte urine test while working in the United States and am extremely impressed with its performance."
If the urine testing program is successful, Dr. Cao said she'll recommend to the Chinese government that a national testing program be employed, utilizing the urine test system.
"Because the urine test is particularly useful for field-testing programs, it should expand the reach of HIV testing from our health centers in cities to remote rural settings," Dr. Cao continued. "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 using blood, whereas a urine test could be an essential and much more easily administered tool in helping to control the epidemic."
"In addition, because there are no accidental needle sticks and other exposure-related dangers involved with urine, health care workers and patients are protected from accidental exposure," Dr. Cao continued.
According to the World Health Organization (WHO), the fastest growth of the AIDS epidemic is in Asia -- especially in China, India and Southeast Asia -- which have among the fastest-growing populations of HIV-infected people in the world. Dr. Cao added, "From a public health management perspective, these nations don't yet have enough information on how and where AIDS is impacting their peoples. The urine test system will provide them with a highly-accurate, cost-effective and non-invasive way to get that vital data."
In June, the U.S. Food and Drug Administration approved the urine HIV-1 Western blot test. The screening test had been approved previously by the FDA. The urine test system consists of the HIV-1 enzyme immunoassay (EIA) antibody screening test and the HIV-1 urine Western blot confirmatory test, which detect the presence of antibodies to HIV-1 in urine samples. Clinical studies have shown the urine diagnostic test system to be a highly accurate alternative to blood testing.
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding market adoption of the HIV-1 urine testing system. 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. Factors which may impact the company's success are more fully discussed in the company's most recent quarterly report on forms 10-Q and 10-K.
For more information on how to purchase or evaluate the product, call Dick Van Maanen of Calypte at 510-749-5100.
Visit Calypte on the World Wide Web at: www Calypte.com
Contact: Healy Communications Jason Sherman/David Schulte, 312/440-3900 or Calypte Biomedical Bill Boeger, CEO/John DiPietro, COO, 510/749-5100
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