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.