SDIX Method for Salmonella Enteritidis Detection Receives Interim NPIP Approval

NEWARK, Del.--(BUSINESS WIRE)--SDIX™ (NASDAQ: SDIX), a leading supplier of rapid detection solutions to the $1 billion food pathogen testing market, today announced that its RapidChek^® SELECT™ Salmonella Enteritidis (SE) test system has been granted interim National Poultry Improvement Plan (NPIP) approval by the Secretary's Advisory Committee on Poultry Health, for use in detecting the presence of SE in poultry environments. The interim approval is in effect until the 2012 Biennial Conference of the NPIP where it will be considered for ratification by the full NPIP technical committee.

The NPIP is a cooperative Federal-State-Industry program developed to prevent or control certain egg-transmitted, hatchery-disseminated poultry diseases, including Salmonella Enteritidis. SDIX offers U.S. egg and poultry producers an easier, faster and more cost effective way to comply with the new FDA regulation that requires SE monitoring of the layer house environment. With this NPIP approval, producers now can also apply these SDIX SE testing advantages to comply with NPIP testing guidelines.

Tim Lawruk, Food Safety Market Manager at SDIX, said, “The NPIP’s approval provides hatcheries, egg layers and the broiler industry with confidence to use the SDIX RapidChek SELECT SE for the accurate detection and control of SE in the production environment. The RapidChek SELECT SE method’s improved sensitivity, reduced time to result and ease-of-use provide a highly effective testing solution for meeting NPIP environmental testing requirements.”

“In addition, the RapidChek SELECT SE method is the only rapid SE test available that uses patented enrichment media for faster detection and improved sensitivity, compared to other NPIP-approved methods. The addition of the RapidChek^® CONFIRM™ immuno-magnetic separation method allows for improved recovery of SE from high background environmental swabs, for improved sensitivity and confirmation that is consistent with the NPIP and FDA procedures.”

This news further validates the RapidChek SELECT SE system and builds on previous announcements in November 2010 and January 2011. In January, the US FDA announced its determination that the method was equivalent in accuracy, precision and sensitivity to traditional testing methods for detecting SE in environmental and pooled egg samples. The FDA Final Rule to reduce SE in egg production dictates that if SE is found in the layer environment, eggs must then be screened for the presence of SE in order to keep any contaminated eggs from reaching the consumer market. In November, the RapidChek SELECT SE method received AOAC-RI Performance Tested Method certification, validating the system for poultry house environmental samples, pooled egg samples and chicken carcass rinses. With these method validations and approvals, SDIX has access to a market estimated to be $8-$12 million related to SE testing. This new opportunity is driven by the new FDA regulations and NPIP testing requirements. SDIX believes the test will be a tool to help significantly reduce SE poultry house contamination levels from those being experienced today by providing a more sensitive and accurate detection of SE.

The new testing system is comprised of the RapidChek® SELECT™ Salmonella Enteritidis detection system for screening environmental drag swabs or pooled eggs and the RapidChek® CONFIRM™ Salmonella Enteritidis immunomagnetic separation system for confirmation of environmental presumptive positive samples.

About SDIX (www.sdix.com)

SDIX is a biotechnology company delivering advanced immuno-solutions and critical reagents to the life science sector, including pharmaceutical, biotechnology, diagnostic, and basic research partners as well as effective pathogen detection tests to help ensure food safety.

In life science, SDIX helps scientists discover the mechanisms of disease, facilitate the development of new drugs, and provide tools for rapid diagnosis through its suite of fully integrated immuno-solutions – from targeted antigen design to create unique antibodies, to assay design, development, and production. In food safety, SDIX rapid assays help customers reduce time, labor, and costs while increasing accuracy and reliability of food pathogen detection.

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