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Thursday February 5, 8:03 am Eastern Time
Company Press Release
Saliva Diagnostic Systems Establishes Packaging in UK
and is Authorized to Sell Rapid HIV Tests in Kenya, Brazil
and Romania
VANCOUVER, Wash.--(BUSINESS WIRE)--Feb. 5, 1998--Saliva Diagnostic Systems, Inc.
(Nasdaq: SALV - news, SALVW - news) today announced that arrangements have been made to
begin the assembling and packaging of its test kits in the United Kingdom where all of Saliva
Diagnostic Systems' rapid test kits have been approved.
In addition to the US site Wesley Coe, Ltd. has been selected as its second site.
''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 |
