IGEN have announced that its PATHIGEN E. coli O157 test, based on the Company's proprietary ORIGEN(R) technology, has earned the Performance Tested Method certificate of the AOAC Research Institute (AOAC RI).

The PATHIGEN E. coli O157 test is the first PATHIGEN test to earn Performance Tested Method status. The AOAC RI validation study was a rigorous independent assessment and review of the PATHIGEN E. coli O157 test to demonstrate that the product meets performance claims. AOAC RI certification for the test kit allows it to be used as part of the food producer's Hazard Analysis and Critical Control Point (HAACP) testing plans, as directed by the USDA for meat producers.

The E. coli O157 test is one of a suite of PATHIGEN products that includes tests for the detection of foodborne pathogens such as Salmonella, Listeria, and Campylobacter. The results of the AOAC RI validation study confirmed that the PATHIGEN E. coli O157 test detects less than one cell in 25 grams of ground beef with 100% specificity and a zero percent false positive rate.

In addition, the test was found to be more sensitive than the USDA FSIS method used for comparison. AOAC RI certification is expected to enhance the Company's introduction of the PATHIGEN E. coli O157 test into the food microbiology market, where the need for fast, reliable detection of the potentially lethal bacteria is important for consumer safety and to avoid costly product recalls.