FDA’s Method Equivalency Finding Triggers Life Technologies to Launch Market’s First PCR Detection Kit for Salmonella Enteritidis in Poultry Eggs
Friday, January 14, 2011
CARLSBAD, Calif. – Jan. 13, 2011 – A collaboration between Life Technologies Corporation (NASDAQ: LIFE) 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.”
Shelley Rankin, associate professor of Microbiology at Penn Vet and lead researcher on this project, said: “The FDA equivalence determination for this test marks a milestone for the egg industry in this country. The Commonwealth was the first state in the nation to initiate a voluntary egg quality assurance program and the Pennsylvania Animal Diagnostic Laboratory System will be the first to implement this new level of testing. It's very exciting that the FDA has adopted this test for the Federal Egg Safety Program. This action demonstrates their commitment to delivering the safest quality food to the consumer and I'm proud to be a part of that trend.”
Life Technologies is committed to facilitating food safety by offering leading products and services designed to help producers test for pathogens. The company’s family of next-generation molecular tools and easy-to-use instruments for PCR analysis provide the complete workflow needed to rapidly monitor food safety in products worldwide.
“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.”
About Life Technologies (www.lifetechnologies.com)
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Life Technologies had sales of $3.3 billion in 2009, employs approximately 9,000 people, has a presence in approximately 160 countries, and possesses a rapidly growing intellectual property estate of approximately 3,900 patents and exclusive licenses. Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc., and manufactures both in-vitro diagnostic products and research use only-labeled products. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com.
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This press release includes forward-looking statements about our anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies’ plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions (“will,” “may,” “could,” “should,” etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.
Penn's School of Veterinary Medicine is one of the world's premier veterinary schools. Founded in 1884, the School was built on the concept of Many Species, One Medicine. The birthplace of veterinary specialties, the School serves a distinctly diverse array of animal patients, from pets to horses to farm animals at our two campuses. In Philadelphia, on Penn's campus, are the Matthew J. Ryan Veterinary Hospital for companion animals, as well as classrooms, laboratories and the School's administrative offices. The large-animal facility, New Bolton Center, in Kennett Square, Pa., encompasses hospital facilities for the care of horses and food animals as well as diagnostic laboratories serving the agriculture industry. The School has successfully integrated scholarship and scientific discovery with all aspects of veterinary medical education.
Visit us on-line at www.vet.upenn.edu