BUSINESS WIRE; Thursday February 5, 8:03 am EST
"With this second site selected we have the capacity to produce the 3-5 million tests forecast for 1998." said Kenneth J. McLachlan, President and CEO. "This is another step towards increasing the capacity we had prior to the cost-cutting measures of closing our Singapore plant in October."
Rapid HIV Tests Approved in Kenya, Brazil and Romania
SDS has also received permission to market and distribute its rapid Hema-Strip(TM) HIV test kit in Kenya, Brazil and Romania and its Sero-Strip(TM) HIV test in Kenya and Romania. SDS believes that approximately 125,000 Hema-Strip tests and 65,000 Sero-Strip tests will be used in the first year of distribution in these countries.
"While our Hema-Strip and Sero-Strip test kits are simple to use, the results are very accurate," continued McLachlan. "The approval process in each country found the tests to have similar sensitivity and specificity to other widely accepted HIV tests. Authorization in these countries broadens our distribution and again confirms the efficacy and quality of our rapid tests."
These approvals add to the growing list of countries where the Hema-Strip and Sero-Strip tests are approved.
Currently Hema-Strip and Sero-Strip are approved or on sale in the following countries:
Brazil, UK, Russia, Kenya, Ghana, Romania, Malaysia, Singapore, Indonesia, Hong Kong, with clinical trials underway in Argentina, Vietnam, South Africa, India, Mexico, China, Philippines, UAE, Kuwait, Saudi Arabia, Haiti, the Pacific islands and others.
Canadian trials with its Canadian partners BioChem ImmunoSystems and APS are scheduled to begin during the first quarter of 1998.
Stat-Simple(TM) pylori was recently launched to the export market where SDS already has an established distribution network. Stat-Simple (TM) pylori, unlike SDS' HIV products, does not require major clinical trials so sales of the product can begin immediately outside of the US. SDS fulfilled its first order commitments for the Helicobacter pylori test to Denmark, Italy and the United Kingdom recently.
Move towards early detection for HIV
"We are also encouraged by a recent report issued by the Centers for Disease Control in Atlanta emphasizing early detection and prevention," continued McLachlan. "The report stresses the need for all US states to report to the CDC statistics for HIV infection rather than cases that have progressed to full-blown AIDS. This is especially important as newer drug treatments are helping prevent some HIV positive individuals from progressing to AIDS. As the number of AIDS cases declines this creates a false impression of the on-going crisis, where in fact the number of HIV positive people is significantly increasing."
In order to facilitate this process the CDC is encouraging small, innovative companies like SDS with the appropriate technology to seek FDA approval at the earliest time.
Saliva Diagnostic Systems, Inc. is a developer and manufacturer of rapid tests for infectious diseases and certain other conditions. The Company is based in Vancouver, Wash. with a sales office in London, England. The Company is in the process of developing rapid serum and saliva tests for Hepatitis A and Tuberculosis. The Company's products include a range of rapid tests to detect HIV antibodies that use serum, whole blood or saliva for analysis. The tests, which require only a few simple steps to use, are designed to produce results within minutes without special equipment, training or storage.
This press release contains forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to vary include the ability of the Company to raise additional capital, demand for the Company's products, the ability of the Company to obtain regulatory approvals, success in the Company's technological advances and their implementation, as well as other risk factors listed in the Company's Registration Statement on Form S-3 dated Sept. 26, 1997.
Contact: Saliva Diagnostic Systems Tel: 360/696-4800 Fax: 360/254-7942
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