SDIX receives FDA method equivalency and AOAC-RI certification for Salmonella Enteritidis test system

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 reviewed by the U.S. Food and Drug Administration (FDA) and determined to be equivalent in accuracy, precision and sensitivity to their current standard methods for poultry house environmental drag swabs and pooled egg testing. For pooled egg testing, SDIX's method is considered by FDA as equivalent to its standard test without a 96-hour hold period, thus delivering results with a substantial time and cost advantage.

“Obtaining both AOAC-RI certification and FDA method equivalency provides egg producers complete confidence that deploying SDIX's rapid methods not only provides great financial benefits, but also ensures that they are complying with the testing requirements of the FDA Final Rule.”

Recently, SDIX's test also earned Performance-Tested Methods (PTM) certification from the AOAC Research Institute (AOAC-RI). The AOAC PTM certification also validated the RapidChek SELECT SE method as equivalent to the FDA methodology for detecting SE in poultry house environments and pooled eggs. With the added FDA equivalency determination, SDIX's test can help the approximately 3,300 egg producers comply with the new FDA regulations and significantly reduce contamination levels from those being experienced today by providing a more sensitive and accurate detection of SE.

The FDA Final Rule 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. With this FDA equivalency ruling, SDIX can offer U.S. egg producers an easier, faster, and cost effective way to comply with that FDA regulation.

According to the USDA and the Center for Disease Control's (CDC) FoodNet surveillance system Salmonella is not only the most common food-borne bacterial pathogen with over 1 million estimated cases annually in the US, but it is also responsible for more hospitalizations and more deaths - almost 400 annually-- than any other food pathogen. Over 500 million eggs were recalled from this past summer's SE outbreak with reports of approximately 1,800 cases of Salmonella poisoning from tainted eggs.

Tim Lawruk, Food Safety Market Manager at SDIX, said, "The RapidChek^® SELECT™ SE test system can deliver results for environmental samples from the layer house one full day faster than the current FDA method and with substantially increased sensitivity and accuracy. These benefits enable egg producers to identify SE in the environment before it contaminates eggs, which helps ensure safer eggs and reduces the possibility of a costly egg recall. This ability to screen for SE quickly and accurately is especially relevant today given the recent egg recalls. For egg testing, the RapidChek SELECT method can provide SE test results 5 days faster than the FDA method, which has a substantial effect on product storage and release for the egg producers."

Continuing, Mr. Lawruk said, "Obtaining both AOAC-RI certification and FDA method equivalency provides egg producers complete confidence that deploying SDIX's rapid methods not only provides great financial benefits, but also ensures that they are complying with the testing requirements of the FDA Final Rule."

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. The FDA statement of method equivalency can be found on the FDA Egg Safety Action Plan website.

Source SDIX