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FDA's Method Equivalency Finding Triggers Life Technologies to Launch Market's First PCR Detection Kit for Salmonella Enteritidis in Poultry Eggs

A collaboration between Life Technologies Corporation and the University of Pennsylvania School of Veterinary Medicine has led to the launch of the first real-time PCR-based detection kit to test for Salmonella enteritidis (SE) in poultry eggs, providing an approximate 10-fold reduction in waiting time for accurate results.

The FDA has determined that the Applied Biosystems TaqMan® Salmonella enteritidis Detection Kit by Life Technologies is equivalent in accuracy, precision and sensitivity to its current standard methods described in the FDA's Bacteriological Analytical Manual (BAM, December 2007 Edition). The company's solution is a comprehensive protocol that uses real-time PCR (polymerase chain reaction) to quickly determine the presence or absence of SE in egg samples. Unlike the current traditional testing method, which can take up to 10 days to complete, Life Technologies' solution reaches accurate results in about 27 hours, making it the only tool of its kind on the market.

"The faster turnaround time to reach accurate results with this new molecular test not only enables egg producers to easily conform to the FDA's new stringent testing standards, but also helps limit the negative economic impact associated with SE outbreaks," said Gene Gregory, President and CEO of the United Egg Producers.

Two of the largest producers in the United States were forced to recall more than 550 million eggs after the August 2010 Salmonella outbreak that affected 26 states and resulted in a 40 percent price hike on the wholesale egg market, as reported by USA Today. The Federal Egg Safety Program, which went into effect July 2010, requires all large-scale egg producers in the U.S. -- roughly 80 percent of the egg production industry -- to test for SE to ensure the safety of products before they reach supermarket shelves. The new regulations created the need for a quicker, yet highly accurate, testing method.

In response to the new federal regulations, Life Technologies developed the test in collaboration with Dr. Shelley Rankin of the School of Veterinary Medicine at the University of Pennsylvania. Life Technologies designed the assays and protocols, and Dr. Rankin's lab validated the protocol and performance.

"Penn Vet has been collaborating with the Commonwealth of Pennsylvania to ensure food safety for decades," said Dr. Joan C. Hendricks, the Gilbert S. Kahn Dean of the School of Veterinary Medicine at the University of Pennsylvania. "The adoption of our egg-testing protocols by the FDA illustrates our researchers' success in their field and the importance that veterinary researchers play in ensuring public health and food safety. I am thrilled that Penn Vet is continuing to lead the way in setting the standard in food safety and public health."

"We are pleased to have received the U.S. Food and Drug Administration's acceptance of our TaqMan® Salmonella enteritidis Detection Kit, which now provides producers with a much faster and effective method for testing eggs," said Peter Dansky, President of Molecular & Cell Biology for Life Technologies. "This most recent development underscores Life Technologies' ability to quickly meet the ever-changing needs of animal and food safety markets, and its position as a leading provider of accurate and reliable molecular tests."

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