Message #26 From:
NewsBot Date: November 27, 2006 10:07:00 AM
CEMI News Chembio and CDC to Develop Rapid Syphilis Test Using Dual Path Platform (DPP(TM)) Technology
MEDFORD, N.Y.--(BUSINESS WIRE)--Chembio Diagnostics, Inc. (OTCBB:CEMI) has signed a Cooperative Research
and Development Agreement (CRADA) with the United States Centers for
Disease Control and Prevention (CDC) to develop a rapid combination test
for syphilis utilizing Chembio’s Dual Path
Platform (DPP™) technology and the CDC’s
patented Syphilis antigens. The test is being designed to detect both
treponemal and nontreponemal antibodies in the same device and therefore
could potentially be both a screening and confirmatory test in a point
of care setting.
A team of scientists from Chembio and CDC will work together to develop
the test. After successful completion of device design and analyses of
experimental data, initiation of field studies and data collection would
proceed in accordance with the Food and Drug Administration (FDA) and
the World Health Organization (WHO) requirements. At that time, CDC will
be responsible, among other matters, for undertaking testing procedures
and clinical trials. Chembio’s
responsibilities will include, among other matters, providing
manufacturing capacity for producing prototype devices and submitting
certain regulatory documents to the FDA.
Lawrence Siebert, President and CEO of Chembio commented, “The
CRADA with CDC illustrates how valuable the DPP technology is to
Chembio. This agreement enables us to simultaneously broaden our rapid
test products beyond our core areas of HIV, Chagas Disease and
Tuberculosis, capitalize on our DPP intellectual property, and
collaborate with the leading public health organization in the U.S. that
has expertise in sexually transmitted diseases such as Syphilis”.
The DPP technology is a point of care test platform, which, based on
internal tests, can overcome the sensitivity and specificity issues
related to conventional lateral flow technology. Chembio believes DPP
will be an excellent platform for a serology test for Syphilis due to
the separate delivery path for sample and simultaneous binding of
antibodies in the samples to several antigens in the test area. Chembio
has posted on its web site at http://www.chembio.com/newtechnologies.html
a video animation of the basic DPP system, which will soon be updated to
include a prototype of an oral fluid (HIV) DPP system under development.
Syphilis is a sexually transmitted disease (STD) caused by the bacterium Treponema
pallidum. Worldwide 12 million individuals are diagnosed with
syphilis each year and are at increased risk of becoming infected with
and transmitting HIV. In addition, syphilis can be transmitted from
infected women to their unborn child during pregnancy. Early and
appropriate diagnosis and treatment prevents infection of the child and
development of severe complications.
The difficulty in following up patients who have undergone syphilis
testing in a variety of settings and testing for syphilis in many
prenatal settings are major obstacles to effective syphilis control. The
development of a rapid, point of care test that combines the sensitivity
of a screening test with the specificity of a confirmatory test will
assist clinicians in providing appropriate treatment during an initial
clinic visit.
The Federal Technology Transfer Act of 1986 (15 U.S.C. 3710a) authorizes
federal agencies to permit Directors of government-operated federal
laboratories to enter into a Cooperative Research and Development
Agreement (CRADA) with a federal or non-federal entity, including a
state or local government, college and university, corporation, sole
proprietorship, and trade association, for the purpose of broadening the
U.S. technological base by disseminating and making available new
knowledge from a Government research laboratory for the development of
new products and technologies
ABOUT CHEMBIO
Chembio Diagnostics, Inc., a developer and manufacturer of rapid
diagnostic tests for infectious diseases, is on the frontlines of the
global battle against the AIDS pandemic. The Company has received
marketing approval from the FDA for its SURE CHECK®HIV 1/2 and HIV 1/2 STAT-PAK™ rapid tests. The
Company also manufactures rapid tests for veterinary Tuberculosis and
Chagas Disease, and has developed a patent-pending technology, the Dual
Path Platform (DPP™), for its next generation
HIV and other rapid tests. For additional information please visit www.chembio.com.
FORWARD-LOOKING STATEMENTS
Statements contained herein that are not historical facts may be
forward-looking statements within the meaning of the Securities Act of
1933, as amended. Forward-looking statements include statements
regarding the intent, belief or current expectations of the Company and
its management.Such statements are estimates only, as the
Company has not completed the preparation of its financial statements
for those periods, nor has its auditor completed the audit of those
results. Actual revenue may differ materially from those anticipated in
this press release. 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 Chembio's ability to obtain additional financing, to obtain
regulatory approvals in a timely manner, and the demand for Chembio's
products. Chembio 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 Chembio's expectations
with regard to these forward-looking statements or the occurrence of
unanticipated events. Factors that may impact Chembio's success are more
fully disclosed in Chembio's most recent public filings with the U.S.
Securities and Exchange Commission.
