SDIX™
(NASDAQ: SDIX), a leading supplier of rapid detection solutions to the
$1 billion food pathogen testing market, today announced that its RapidChek®
CONFIRM™ non-O157 STEC Immunomagnetic Separation (IMS) test kit has
been reviewed by the U.S. Department of Agriculture (USDA) and has been
listed in the recently updated USDA
Microbiological Laboratory Guidebook (MLG) 5B.02 as the IMS reagents
to be used in E. coli testing.
On June 4, 2012, the USDA Food Safety Inspection Service (“FSIS”) began
monitoring of the “Big Six” non-O157 shiga toxin producing E. coli (STEC),
incorporating the RapidChek® CONFIRM™ STEC test
kit in their testing method. Recently, one of the Big Six, E. coli
O145 has been implicated in an E. coli outbreak in the
southern US, though the source has not been identified.
Tim Lawruk, Food Safety Marketing Director at SDIX, said, “Once again
SDIX has been able to apply its expertise in antibody development to
validate six highly specific antibodies to address the new USDA
regulation for monitoring non-O157 STEC in beef products. The decision
by the USDA to incorporate our IMS product into their testing method
over competitive offerings further validates the performance of SDIX’s
antibodies. Working with the USDA FSIS, we were able to quickly develop
and validate these reagents to meet the market’s needs. We expect these
reagents to be a valuable tool for the USDA, state and international
regulatory agencies, and customers in the beef industry."
Continuing, Mr. Lawruk said, “The MLG is considered the "gold standard
guide" to testing methods by many in the food safety industry. Our
listing in the MLG should provide testing labs confidence that deploying
SDIX’s confirmation reagents will ensure that they are complying with
the testing requirements of the USDA. Based on customer requests for
additional STEC testing tools, we will also be incorporating these
antibodies into a RapidChek non-O157 test kit to be launched shortly,
which includes multiplexed lateral flow test strips for the verification
of “Big Six” O-type. We expect these new IMS bead and test kit products
to provide SDIX additional access to the estimated $57M E. coli
testing market, which by some industry estimates, is expected to double
over the next 3 years."
About SDIX (www.sdix.com)
SDIX is a biotechnology company with a core expertise in creating better
antigens, better antibodies and better assays for the pharmaceutical,
biotechnology and food safety markets. For over 20 years, SDIX has been
a leading immuno-solutions company, developing results-oriented and
innovative antibody-based solutions that enable customers to meet high
performance research, diagnostic and commercialization objectives.
In the life science market, SDIX’s technology and capabilities are being
used to help discover disease mechanisms, facilitate development of new
drugs and provide antibodies and assays for the diagnosis of disease. In
the food safety market, SDIX continues to expand its footprint as an
international supplier of rapid pathogen test technologies that enable
more accurate and cost-effective results.
This news release may contain forward-looking statements reflecting
SDIX's current expectations. When used in this press release, words like
“anticipate”, “could”, “enable”, “estimate”, “intend”, “expect”,
“believe”, “can”, “potential”, “will”, “should”, “project”, “plan” and
similar expressions as they relate to SDIX are intended to identify said
forward-looking statements. Investors are cautioned that all
forward-looking statements involve risks and uncertainties, which may
cause actual results to differ from those anticipated by SDIX at this
time. Such risks and uncertainties include, without limitation, changes
in demand for products, the application of our technologies to various
uses, delays in product development, delays in market acceptance of new
products, retention of customers and employees, adequate supply of raw
materials, inability to obtain or delays in obtaining fourth party, or
required government approvals, the ability to meet increased market
demand, competition, protection of intellectual property,
non-infringement of intellectual property, seasonality, and other
factors more fully described in SDIX's public filings with the U.S.
Securities and Exchange Commission.
