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eResearch
On-line Technical Bulletin  •  Volume 8 Issue 1 — May, 2010

In this issue of eResearch...

SQI Diagnostics Signs Development Agreement with Silliker
Colorado State University, Cornell University and Silliker to Co-Sponsor
    "Third Annual Molecular Methods in Food Microbiology Symposium
    and Workshop Series" at Colorado State University
Regulatory News: United States Department of Agriculture Issues
    Long-Awaited Pathogen Performance Standards for Poultry
Black, Radjke Join Silliker Food Science Center Staff
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SQI Diagnostics Signs Development Agreement

with Silliker

SQI Diagnostics Inc., a leading medical systems automation company focused on evolving laboratory-based biomarker testing, has entered into a development agreement with Silliker, Inc. for the commercialization of a botulism toxin panel that will run on SQI's SQiDman(TM) analytical system.

When cleared for marketing, the IgXplex BOTX panel will be used in research studies to determine conditions under which botulinum toxin can be produced in foods. Gathered information will aid in implementing preventative controls, quickly detecting botulinum toxins in commercial products suspected of causing disease, and identifying product holding conditions that might increase toxin production. The botulism panel under development has the potential to replace current commercial testing methodologies. The IgXplex BOTX assay is based on SQI's core FDA-cleared IgXplex multiplexing technology that generates multiple results in a single well in the human in-vitro diagnostics autoimmune market.

Prior to the agreement, SQI developed a proof-of-concept of the botulism panel for Silliker, which met all endpoints required for acceptance for the company to launch internal studies to verify method performance and validate equivalence to current methods.

Silliker, under terms of the agreement, will purchase SQiDman systems and IgXplex consumables upon successful development and AOAC validation for the test panel and system. In exchange for the purchase requirements of IgXplex BOTX assays, SQI has granted exclusive global market and distribution rights to Silliker to resell the assay and SQiDman system to its customers.

"Our emerging customer relationship with Silliker is a continuation of our commercialization process overall as a company and in particular for this market," said Claude Ricks, CEO of SQI Diagnostics. "We look forward to working with Silliker in its growth of food toxin and antigen-based multiplexed testing on the SQI platform, and building out a pipeline of tests in this field."

"For a number of years there has been a need for a rapid, sensitive and specific diagnostic test for botulinum toxins," said Dr. Russ Flowers, Chairman and Chief Scientific Officer of Silliker Group Corp. "We are pleased to be able to offer this service to our customers."

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Colorado State University, Cornell University and

Silliker to Co-Sponsor "Third Annual Molecular

Methods in Food Microbiology Symposium and

Workshop Series" at Colorado State University

Colorado State University, Cornell University, and the Silliker Food Science Center will co-sponsor the third annual "Molecular Methods in Food Microbiology" workshop at Colorado State University (Fort Collins), June 28 - July 2, 2010. Designed for current and future food safety professionals, the symposium and hands-on workshop provides a thorough overview of molecular detection of foodborne pathogens and spoilage organisms.

Instructors and speakers scheduled to participate in the weeklong event include: Martin Wiedmann (Cornell University), Mark Carter (Silliker Group Corp.), Sarita Raengpradub-Wheeler (Silliker Food Science Center), Haley Oliver (Cornell University) and Kendra Nightingale (Colorado State University).

This year's workshop will cover nucleic acid-based detection methods, focusing on PCR-based detection and confirmation methods (including PCR, multiplex PCR assays, real-time PCR), including DNA sequencing of PCR products. A major segment of the program will address new developments in technology and biological targets (e.g., detection of shiga toxin encoding Escherichia coli (STEC), multidrug resistant Salmonella, etc.) using current examples.

Attendees will become familiar with commercial DNA-based detection methods (including data interpretation and troubleshooting) as well as approaches to design custom PCR-based assays and protocols for foodborne pathogens and spoilage microorganisms. This one-week program includes a one-and-a-half-day lecture series and symposium (unlimited registration), as well as a three-day hands-on workshop (registration limited to 30 people).

An advisory committee was assembled to help the workshop instructors identify challenges the food industry and regulatory agencies face today with respect to molecular detection. Members of the advisory committee include: Kathryn Boor (Chair, Department of Food Science, Cornell University); Tim Freier (Director, Global Food Safety Technologies, Cargill); Paul Hall (Food Safety Consultant); Scott Hood (Senior Manager, Microbiology, General Mills); Yuewei Hu (Microbiologist, General Mills); Randy Huffman (Chief Food Safety Officer, Maple Leaf Foods); Keith Lampel (U.S. Food and Drug Administration); Jennifer Lee (Principle Scientist, PepsiCo); Mark Moorman (Senior Director, Food Safety and Chemistry, Kellogg Company); Theo Morille-Hinds (Associate Program Director of Global M & FS, Kraft Foods); Bob Reinhard (Director Food Safety, Sara Lee Food and Beverage); Yuhuan Chen (Microbiologist, Grocery Manufacturers Association); and Les Smoot (Director, Nestle Quality Assurance Center).

Please click here to access and download a copy of the program brochure. To learn more about meeting, please contact Kendra Nightingale (kendra.nightingale@colostate.edu) or Sarita Raengpradub-Wheeler (sarita.raengpradub@silliker.com).

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Regulatory News:

United States Department of Agriculture Issues

Long-Awaited Pathogen Performance Standards

for Poultry

The USDA Food Safety and Inspection Service (FSIS) has issued new pathogen reduction performance standards for the control of Salmonella and Campylobacter in chilled carcasses at young chicken (broiler) and turkey slaughter establishments. The long-awaited performance standards have been called the most significant change in FSIS inspection policy since the adoption of HACCP in 1996. The standards are notable as the first performance standard for Campylobacter and the first revision to the existing Salmonella standard for chicken. The agency plans to implement the new standards by July 2010, and expects all establishments will comply with the standards by the end of the year.

Based on the results of the recent FSIS baseline sample collection programs for young chickens and turkeys, the new standards established a threshold for positive samples for pathogens that should be met by establishments. For example, the Salmonella performance standard for broilers set a limit of 7.5 percent for positive samples. FSIS inspectors will continue to test 51 samples in a Salmonella verification set for broilers, but the set will now include testing for Campylobacter. The Campylobacter standard for broilers established a limit of 10.4% for 1 mL portions with no more than eight positive samples. To support the implementation of the standards, FSIS has issued an updated guidance document, entitled "Controlling Salmonella & Campylobacter in Poultry."

The presence of Salmonella and Campylobacter on poultry was recently highlighted in an independent survey by the Consumers Union. The consumer advocacy group conducted a survey of 382 fresh, whole broilers from 100 grocery stores in the United States to determine the presence of bacterial pathogens on raw chicken. The study of retail chicken uncovered the presence of Campylobacter on 62% and Salmonella on 14% of the chickens tested. The group reported that only 40% of air-chilled chicken carried the pathogens in contrast to a higher positive rate for broilers chilled by chlorinated water.

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Black, Radjke Join Silliker Food Science Center Staff

General Manager Cynthia Stewart, Ph.D., recently announced the additions of Rhonda Black and Jerri Radjke to the Silliker Food Science Center staff. Black and Radjke were named Operations Manager of Specialized Services and Research Project Leader, respectively. With extensive food industry backgrounds, Black and Radjke bring over two decades of combined industry experience to the South Holland, IL, contract research organization.

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