Calypte's HIV-1 Urine Test Approved for Use in People's Republic of China
ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 24, 2000--
Safer, Easier Test Can Play Key Role in China's Efforts to Control Spread of HIV/AIDS
Calypte Biomedical Corporation (Nasdaq: CALY) announced today that its HIV-1 antibody urine test has been approved by the State Drug Administration (SDA) of the People's Republic of China (PRC), making it the only urine-based HIV-1 test approved for distribution within China. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), half a million Chinese citizens are currently infected with the HIV virus. Left unchecked, officials of the Chinese National Center for AIDS Prevention and Control (NCAIDS) estimate that the total number of HIV infections in China could reach 10 million before 2010. NCAIDS is a national research center run by the Chinese Academy of Preventive Medicine (CAPM), which is under the leadership of the Chinese Ministry of Health.
In June of this year, Calypte announced that it had partnered with NCAIDS through Beijing HuaAi Science and Technology Development Co. Ltd. to distribute Calypte's HIV-1 urine test within the PRC. Beijing HuaAi has contracted with Guizhou Zheng Xin Industry Company, Ltd. to handle sales and distribution logistics through Guizhou Zheng Xin's 180-person dedicated sales force and its 26 offices throughout the PRC. Guizhou Zheng Xin will begin training its sales and technical staff in September to support the distribution of the Calypte test. NCAIDS and CAPM have guaranteed the terms of the contract.
"The approval of the Calypte HIV urine test in China is an important milestone in expanding the reach of Calypte's urine-based product internationally," said Nancy E. Katz, President and CEO of Calypte. "With the number of HIV-infected people in China growing at a rate of 30 percent each year and the reported difficulty in obtaining blood samples from a substantial percentage of those in high risk groups, there is significant unmet need for an effective, easy-to-use alternative. Now that Calypte's urine-based test has been approved for distribution throughout China, we look forward to addressing that demand. We currently plan to begin shipping tests in the fourth quarter of this year."
A key to slowing the spread of HIV lies in a widespread screening program. However, according to Xiwen Zheng, MD, Executive Deputy Director of NCAIDS, during recent HIV detection efforts in China, roughly 30 percent of people to be tested were unwilling to have their blood drawn for traditional HIV tests.
"The SDA approval is very important because Calypte's urine-based HIV test is ideal for our testing programs - this action will pave the way for us to launch major screening efforts," said Dr. Yunzhen Cao, Deputy Director of NCAIDS and Director of the Department of Clinical Virology. "We plan to have our regional laboratories fully trained in the use of this new technology before the end of September." Dr. Cao helped develop Calypte's HIV-1 urine enzyme immunoassay test and is a co-holder of the urine HIV antibody patent, along with Alvin Friedman-Kien, MD. They were the first to report the detection of antibodies to HIV in urine.
PRC government figures indicate that intravenous drug users account for 70 percent of the HIV-positive population in the PRC, a rate ten times higher than that of patients infected by sexual transmission. Those figures are a marked contrast to most of the rest of the world, where the majority of HIV transmissions are caused by unsafe sexual relations.
"There are approximately 10 million drug users in China, and we have found that it can be difficult to collect blood samples from them," said Dr. Cao. "Providing drug users with the option of urine testing could significantly increase the number of people who get tested for HIV."
Another potential reason for the accelerating spread of HIV within the PRC is the dangerous practice of selling blood on the black market. Since blood collection in this market is usually conducted using unsterile methods, donors are often exposed to an array of blood-borne diseases. Although outlawed by China in 1998, recent media reports claim that the practice remains fairly common among China's poorest citizens. In addition, a report from UNAIDS indicates that only five percent of estimated HIV/AIDS cases are actually reported, further compounding the danger of illegal blood sales.
Calypte's HIV urine test offers significant advantages over traditional HIV blood tests because unlike blood, no medical training is required to collect urine samples. In addition, the safety of both the patient and healthcare personnel are enhanced because the urine of HIV-infected people does not appear to harbor the infectious virus itself - only the harmless antibody that signifies prior exposure to HIV. According to information provided by the U.S. National Institutes of Health, there is no evidence that HIV is spread through urine. Urine sampling is also highly flexible and can be employed in a wide range of settings because, unlike blood, urine is very stable and requires no refrigeration.
Calypte Biomedical Corporation (NASDAQ: CALY) is a health care company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other chronic illnesses. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-licensed HIV-1 antibody tests that can be used on urine samples. The Company believes that accurate, non-invasive urine-based testing methods for HIV and other chronic diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly.
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 products and the serum Western Blot test and statements regarding marketing and distribution arrangements and plans. 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 the Company's ability, directly or through third parties, to successfully manufacture and market the HIV-1 urine testing products and the serum Western Blot test and the ability of the Company to continue to finance its operations and to enter into distribution and marketing arrangements. 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 the occurrence of unanticipated events. Factors which may impact the Company's success are more fully disclosed in the Company's most recent periodic reports on Forms 10-K and 10Q.
CONTACT: Calypte Biomedical
Nancy Katz, 510/749-5100
or
Ketchum
James Larkin, 415/984-2285 |
