FDA's Method Equivalency Finding Triggers Life Technologies to Launch Market's First PCR Detection Kit for Salmonella Enteritidis in Poultry Eggs
Developed with the University of Pennsylvania School of Veterinary
Medicine, the rapid molecular test provides a 10-fold reduction in
waiting time for results
CARLSBAD, Calif.--(BUSINESS WIRE)--
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.
Life Technologies' Safe Harbor Statement
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.
About the University of Pennsylvania School of Veterinary Medicine
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 MedicineTM.
Penn Vet researchers currently have the most National Institutes of
Health grants of all vet schools in the country, attesting to the
School's strong basic and clinical research programs in infectious
diseases, immunology, neuroscience, cancer, stem cell biology and more.
For more information about the research at Penn Vet, visit www.vet.upenn.edu/Research.
The School's Matthew J. Ryan Veterinary Hospital, located on Penn's
campus in Philadelphia, PA, houses classrooms, laboratories, medical
care and one of the nation's busiest urban veterinary emergency rooms.
In addition, the school successfully integrates scholarship and
scientific discovery with all aspects of veterinary medical education.
Penn's School of Veterinary Medicine is the only institution in the
state of Pennsylvania graduating veterinarians accredited to care for
food production animals. 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.
For more information about Penn Vet or its hospitals, visit www.vet.upenn.edu.
Life Technologies Contact
Mauricio Minotta
760-929-2456
Mauricio.minotta@lifetech.com
or
Penn
Veterinary Medicine Contact
Kelly Stratton
215-898-1475 or
610-554-7930
skell@vet.upenn.edu
Source: Life Technologies Corporation
News Provided by Acquire Media
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