Business Wire - November 23, 2001
"Our expanding relationship with a company like SA Scientific, that has both rapid test development experience and extensive manufacturing capabilities, in conjunction with our expertise in urine HIV testing, will allow us to even more effectively address the global threat of HIV/AIDS," said Calypte Biomedical's President, CEO and CFO Nancy E. Katz.
"We believe that Calypte's existing urine-based HIV testing products are already particularly well-suited for use in developing countries. The added advantages of a rapid test will be even more attractive for use both here in the U.S. and in developing countries where fully equipped laboratories or even basic testing infrastructure is often lacking."
Calypte and SA Scientific expect that their one-step, urine-based rapid HIV test will provide safe, cost-effective, painless results within that 15 minute period without the need for lengthy or complex laboratory analysis. By comparison, depending on a given lab's workflow and efficiency, standard HIV tests can take weeks to process, and also require a patient's telephone contact or return visit to obtain their test results.
The companies expect to manufacture the product at SA Scientific's Texas facilities, which are FDA and USDA registered, and certified for ISO 9001. SA Scientific also will work with Calypte to facilitate FDA clearance for marketing of the rapid HIV urine test in the United States. In light of a potentially lengthy FDA review process, initial distribution in offshore markets is anticipated. At that point, Calypte and SA Scientific expect the assay to be the first urine-based rapid HIV antibody test on the market.
Calypte and SA Scientific have already been informally collaborating in adapting SA Scientific's proprietary rapid test platform to a urine HIV-1/2 test format, with encouraging results. As a result, the formal agreement that has now been reached continues development with the goal of a long-term relationship to include the manufacture and distribution of the product, once development is completed.
The test is intended for administration by trained healthcare professionals in clinical settings, and will be similar in function to SA Scientific's home pregnancy tests, which also use urine as the sample fluid. Calypte already produces the only FDA approved HIV-1 antibody urine tests.
Urine testing in general offers significant advantages over traditional HIV blood tests and oral fluid-based tests because no special training is required to collect urine samples, and inadequate sample collection is unlikely to be an issue. 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. Perhaps most importantly, studies in the U.S. and elsewhere have demonstrated that people are significantly more willing to be tested by urine than by blood. Once the urine sample has been collected, it can also be assayed for a variety of other HIV-pertinent conditions, such as pregnancy, drug abuse, and other STDs such as gonorrhea and Chlamydia.
The Centers for Disease Control (CDC) has called for the development of rapid HIV tests as part of its "HIV Prevention Strategic Plan Through 2005," since such tests could provide patients with on the spot results. "Calypte supports the CDC initiative to make rapid HIV testing available to health professionals worldwide as part of the effort in arresting the spread of HIV," Katz said.
SA Scientific Inc., founded in 1984, is a manufacturer of rapid one-step diagnostic tests for both the U.S. and nearly 80 countries in the international market. Their products include tests for pregnancy and infectious diseases such as Strep A, adenovirus rotavirus and food pathogens such as E. coli and salmonella.
Calypte Biomedical Corp., headquartered in Alameda, is a public healthcare 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 infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved 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 infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners.
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, marketing arrangements and plans, and shipments to and regulatory approvals in international markets. 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, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue to expand. 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-K for the year ended Dec. 31, 2000 and its subsequent filings with the SEC.
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