SDIX to Help Egg Producers Meet New FDA Regulatory Challenge Easy Use, Cost-Effective RapidChek® SELECT™ Salmonella Enteritidis Designed Specifically for New FDA Regulation Business Wire NEWARK, Del. -- July 12, 2010 SDIX™ (Strategic Diagnostics Inc., d/b/a SDIX, Nasdaq:SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, today commercially launched the RapidChek® SELECT™ Salmonella Enteritidis testing system. The new system was designed in coordination with leading experts in egg safety. It is applicable to both egg and poultry industries. However, it will specifically help U.S. commercial egg producers comply with the new Food and Drug Administration (FDA) regulation that requires them to test poultry houses and eggs for Salmonella Enteritidis (SE). The new FDA rule became effective July 9, 2010 for commercial egg producers with over 50,000 laying hens and becomes effective July 9, 2012 for egg producers with between 3,000 and 49,999 laying hens. The new Rule will affect approximately 4,000 commercial egg producers in the USA. It is estimated that 47 billion eggs are consumed annually in the U.S. and according to reports from the USDA and FDA, there are 2.3 million eggs annually contaminated with Salmonella Enteritidis. The RapidChek SELECT system is an easy, accurate, flexible, and rapid food pathogen detection technology. It combines the simplicity of advanced immuno-based detection system with SDIX’s proprietary, patented phage-based enrichment media to significantly enhance both the specificity and sensitivity of the test and to enable improved pathogen detection. The system is designed to: *Make it easier to comply with the new FDA Rule – easy to learn and use, fast results, robust detection for a better overall picture of hen house cleanliness, layer health, and egg safety *Help minimize disruption to daily operations – high accuracy virtually eliminates false positives. Ease of use and speed to results reduce workflow impacts *Help minimize costs – reduces training, labor, operating costs. Reduced false positives decreases unneeded egg testing costs The RapidChek® SELECT™ Salmonella Enteritidis system has been evaluated at several large egg producers and independent testing laboratories during development to ensure it meets customer needs. Significant validation work has already begun and the Company expects to submit the system to the FDA, AOAC RI, and NPIP for approval and certification during the second half of 2010. The new testing system is comprised of the RapidChek® SELECT™ Salmonella Enteritidis detection system for screening environmental drag swags or pooled eggs and the RapidChek® CONFIRM™ Salmonella Enteritidis immunomagnetic separation system for confirmation. Tim Lawruk, SDIX Food Safety Marketing Manager, said, “Commercial egg producers are faced with significant technical and business challenges as they strive to meet the FDA’s new requirements for both poultry house and egg testing. The new RapidChek SELECT Salmonella Enteritidis testing system is specifically designed to help them meet those challenges and provides SDIX with an opportunity to leverage its expertise in pathogen detection. The system offers competitive advantages that include ease of use, low start-up and operating costs, and a faster time-to-result than other methods. Moreover, the new system’s high accuracy virtually eliminates false positives and the harmful business impacts they can have. It enables egg producers to focus more on their core business of providing safe, high-quality eggs.” About SDIX (www.sdix.com) SDIX is a biotechnology company, expert at creating advantage by providing a broad range of quality, innovative, and effective immuno-solutions to the pharmaceutical, biotechnology, diagnostics, and food safety markets. For nearly 20 years, SDIX has developed antibodies which advance its customers’ immuno-based work – reducing time, labor, and costs while increasing accuracy and reliability of results. SDIX offers a full suite of integrated immuno-solution capabilities including assay design, development, and production. In life science markets, SDIX capabilities are being used to help discover the mechanisms of disease, facilitate the development of new drugs, and provide mechanisms for rapid diagnosis. 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”, “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. Contact: SDIX Tim Lawruk Food Safety Market Manager 302-456-6789 firstname.lastname@example.org
SDIX to Help Egg Producers Meet New FDA Regulatory Challenge
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