Life Technologies Signs Five-Year Food-Safety Agreement with the FDA

Life Technologies Corporation today announced that it has signed a five-year agreement with the Food and Drug Administration (FDA) to accelerate and advance food safety testing of E. coli and Salmonella, two foodborne contaminants commonly associated with outbreaks and/or recalls.

The collaboration consists of three distinctive projects:

1. Life Technologies will design and validate new food safety tests for the detection and identification of foodborne pathogens, with pathogen strains provided by the FDA.

2. Life Technologies will design and validate a complete workflow for food pathogen detection on the Ion PGM™ platform, while optimizing sample preparation methods.

3. The FDA will have the opportunity to evaluate new disruptive technology platforms by Life Technologies for the use in pathogen detection.

Life Technologies will use its bioinformatics resources to independently develop real-time PCR (polymerase chain reaction) assays against unique E. coli and Salmonella targets in collaboration with the FDA.  It will then provide the test results for these targets to the FDA for further validation.

The FDA will use Life Technologies' Ion PGM™ Sequencer to generate whole genome sequence information from defined bacteria, and for strains that will be excluded from detection.  Life Technologies' bioinformatics team will then analyze the genomic information and provide assays or tests to the FDA for further validation and analysis. Whole genome sequences generated under the collaboration will be added to the National Institutes of Health Genbank so they can be accessed by the food safety research community.

"We are excited to be entering this cooperative research and development agreement with the FDA as we have been working alongside them in one capacity or the other for over 10 years," said Nir Nimrodi, Vice President and General Manager for Food Safety and Animal Health at Life Technologies.  "The FDA will call on us, particularly when it comes to developing rapid detection kits.  This agreement allows them to have new rapid track and trace products for rapid identification of foodborne contaminants."

Lastly, the FDA will validate and test Life Technologies' next-generation sequencing technologies for Salmonella investigations as part of its effort to develop new rapid detection tools that can improve the public health response to future outbreaks.

The Obama administration has been slow to enact the 2011 Food Safety Modernization Act, proposing regulations just this year to protect the public. The law stemmed from outbreaks and poisonings in cookie dough, spinach, jalapenos and other foods that killed at least nine people and sickened more than 700 in 2008 and 2009. Total cases of food-borne illness were unchanged last year from 2006-2008, stalling previous declines.

Life Technologies has a strong history of combating pathogen outbreaks.  In 2011, Life Technologies developed a custom assay to accurately detect the highly pathogenic E. coli 0104:H4 bacterium that spread through Europe, killing hundreds of people.

"The assay was developed using samples supplied by scientists at University Hospital Munster, who completed the DNA sequencing and analysis work on the deadly E. coli strain using the Ion PGM™ Sequencer," said Maneesh Jain, Ion Torrent Vice President of Marketing for Life Technologies. "Now the FDA will validate and test this same technology to understand the molecular relationship within the Salmonella pathogen in the hopes to prevent future outbreaks from occurring."

The PGM™ offers scientists the simplest and fastest workflow, lowest cost-per-sample, and highest sensitivity for multiple basic and clinical research applications.

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BD, Diagenode Announce European Launch of Real-Time PCR Kit for Bordetella pertussis & parapertussis

BD Diagnostics, a division of global medical technology company BD (Becton, Dickinson and Company), and Belgium-based international biotech company, Diagenode SA have announced the exclusive European launch of the Real-Time PCR kit (polymerase chain reaction) of Diagenode for Bordetella pertussis and parapertussis for use with the BD MAX system.

The Real-Time PCR Kit for  Bordetella pertussis and parapertussis  from Diagenode has received CE marking and has been validated for use with the BD MAX System. Here, the BD MAX  EX k-1  DNA Extraction Kit was used, where it is an open Systemreagenz. The BD MAX  System is a fully automated system that standardizes the extraction process and offers customers a user-friendly and improved workflow in the laboratory.

Bordetella pertussis  is a pathogen that about 30 to 50 million cases of the highly contagious respiratory disease pertussis or "whooping cough" caused each year.  Early detection by PCR is crucial to prevent spreading the disease and the risk of large to minimize disease outbreaks. PCR tests are ideal for rapid differential diagnosis of pertussis to other respiratory diseases such as atypical pneumonia, bronchitis or respiratory viruses.

"There is a need to get to grips quickly with the outbreak of whooping cough related problems - both children and adults," said Gregory Meehan , vice president of product planning at BD Diagnostics -. Diagnostic Systems "With the real-time PCR kit for  Bordetella pertussis and parapertussis  will expand the syndrome-specific offer for our partners assay is a test that not only comes in handy, but also contributes significantly to meet the market needs. "

Most often infants and young children are affected by the disease, especially in infants aged less than one year may be fatal. Adults may also be affected. In contrast, older children and adults suffering with declining natural or vaccine-induced immunity to diverse symptoms that need to be examined closely in order to make a definitive diagnosis.

Infection with  Bordetella parapertussis  is similar to the infection with  B. pertussis , but extends less serious and is of shorter duration.  Approximately 40 per cent of all persons with an infection  as parapertussis  suffer, are asymptomatic.  People of all ages can come up with  as parapertussis  infection and of developing the infection. Nevertheless parapertussis occurs most frequently in children aged below 10 years.

By working with leading IVD developers ( in vitro diagnostics)  as Diagenode expands its selection of BD molecular tests on quickly and provides specific syndrome and clinically significant IVD assays for a number of different disease syndromes. "With the real-time PCR kit for  Bordetella pertussis and parapertussis  Diagenode of the BD MAX  system is supplemented by a significant assay, with that comes the flexibility and versatility of the platform to its best. In conjunction with the open system reagents timely development of molecular assay tests is favoured, "said Didier Allaer , CEO of Diagenode.

The more comprehensive portfolio for the BD MAX  System and its open architecture, full automation and standardized workflow are laboratories offer the possibility of a wide range of different molecular tests combine and standardize so that they can develop programmes to their current and future clinical needs suffice.

BD is a leading global medical technology company, medical devices, instrument systems and reagents, develops, manufactures and sells.

Diagenode is a leading developer and marketer of innovative life science tools and systems for epigenetics and molecular diagnostics. Diagenode developing novel products for infectious diseases, but also provides a complete solution for epigenetic research.

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Listeria Monocytogenes PCR Assay Offers Validated Method for Fast, Simple Detection of Food Pathogens

Food microbiology laboratories can now confidently test to a recognized standard for Listeria monocytogenes with the Thermo Scientific SureTect Listeria monocytogenes Assay, which has been granted Performance Tested MethodSM status by the AOAC Research Institute.

Listeria monocytogenes can be present in a variety of foodstuffs, including some processed meats and cheeses, and in fresh foods such as cantaloupe melon and raw spinach.

The SureTect Listeria monocytogenes PCR Assay has proven to be comparable to the reference method ISO 11290-1:1996, including Amendment 1:2004 (Listeria monocytogenes). This follows the recent granting of AOAC-RI Performance Method status for the SureTect Salmonella species PCR Assay.

"We are delighted to have received validation of our Listeria monocytogenes PCR assay, which is one of a number of assays we offer for molecular food testing," says Sumi Thaker, VP Global Marketing, Microbiology, Thermo Fisher Scientific. "These assays are part of the SureTect Real-Time PCR System that has been designed to streamline test workflow and reduce time to result, which are primary considerations in today's pathogen test selection. We anticipate validation on a number of new assays over the next few months."

The SureTect System was developed to detect microorganisms quickly and accurately in a broad range of foods and associated samples. This unique solution combines:

Ease of use: Pre-filled lysis tubes and tableted PCR reagents to minimize the number of pipetting steps and hands-on time.

Speed: Optimized single enrichment step for key food matrices and straightforward sample lysis in less than 20 minutes.

Convenience: Common PCR protocols facilitate efficient processing of multiple assays in the same run.

Superior PCR Technology: Probe-based real-time assays for unparallel sensitivity and specificity.

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Genisphere Licenses 3DNA Dendrimer Signal Amplification Technology to Chembio for Lateral Flow Rapid Test Applications

Genisphere LLC has licensed its 3DNA® Signal Amplification technology to Chembio Diagnostics, Inc., a leader in point-of-care ("POC") diagnostic tests for infectious diseases. Chembio plans to use the signal enhancing technology for its Dual Path Platform (“DPP®”) rapid diagnostic pipeline tests, with the goal of achieving detection limits unique to rapid immunoassays thereby broadening potential applications of its technology by combining it with the Genisphere technology.

“Sensitivity, specificity and reproducibility are important features for all diagnostic tests,” said Lawrence Siebert, Chembio's chief executive officer. “We believe Genisphere’s technology can further enhance the performance of our DPP® based assays leading to commercial success in this competitive marketplace."

Genisphere’s 3DNA® Dendrimer technology has been used to improve the performance of a variety of assay platforms for protein and nucleic acid detection, including microarrays, ELISAs, bead-based flow cytometry, and most recently, lateral flow assays. The 3DNA® Dendrimer technology provides up to 100-fold improvement in sensitivity without increasing the assay’s complexity. This improved performance enables point-of-care analyses that have not previously been possible with conventional systems.

The agreement between the two companies comes after a feasibility study in which Genisphere demonstrated the 3DNA® Dendrimer can be adapted to Chembio's Dual Path Platform. Such a close working relationship is a crucial part of Genisphere’s approach.

“Genisphere’s business strategy is to partner with a few key successful players in growing markets,” said Jim Kadushin, Genisphere’s chief operations officer, “We believe Chembio is poised to continue its growth via the combination of our technology with their assay and reagent development activities.”

Genisphere and Chembio will be presenting their respective products and technologies at this year’s AACC meeting, to be held July 29 - Aug 2 in Houston Texas.

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Enigma Diagnostics Announces Successful Completion of Flagship Enigma ML System Evaluation at Guy's and St. Thomas' NHS Foundation Trust

Enigma Diagnostics Ltd announces that it has successfully completed analytical and diagnostic verification of its FluAB-RSV diagnostic assay on the Enigma® ML system at Guy's and St Thomas' NHS Foundation Trust, and will conclude clinical validation and CE marking of the test in 2013.

Enigma has installed a number of mini laboratory (ML) instruments at Guy's and St. Thomas' for use at the Trust's Centre for Clinical Infection and Diagnostics Research (CIDR). During May and June 2013, several hundred clinical samples, obtained by Enigma from patients in Africa with symptoms of respiratory disease, were processed on the Enigma® ML system and compared with data from the Luminex xTAG respiratory viral panel, showing comparable sensitivity and specificity between the two systems.  The Enigma® ML achieved negative predictive value (NPV) and positive predictive value (PPV) values of 100% for the FluB and respiratory syncytial virus (RSV) components of the assay and NPV and PPV of 97% and 100% for the FluA component of the assay.

The Enigma®ML system has the capability to deliver PCR-based results from a raw sample in about 60 minutes and Enigma, in addition to the FluAB-RSV test, is developing a series of deeply multiplexed assays for the Enigma® ML including panel tests for respiratory viruses, multi-drug resistant tuberculosis and other respiratory infections.

John McKinley, Chairman of Enigma Diagnostics, said: "We are delighted to be collaborating with such a prestigious and influential clinical centre. Having achieved such an exceptional diagnostic performance on our Enigma® ML system with the FluAB-RSV assay, we are now ready for validation and CE marking."

Dr Jonathan Edgeworth, Consultant Microbiologist and Head of the Centre for Clinical Infection and Diagnostics Research, said: "We are pleased that Enigma has chosen Guy's and St. Thomas' as its partner to test the performance of the Enigma® ML system. This will provide an opportunity to influence the development of a testing system that has potential to benefit patients in the future.

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FDA Grants Marketing Approval for Cepheid's Xpert MTB/RIF for Mycobacterium tuberculosis

Cepheid, a leading molecular diagnostics company, has received market authorisation from the US Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market. Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene.

"With results available to clinicians in approximately two hours instead of weeks, the dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the US," said John Bishop, Cepheid's chairman and chief executive officer. "Now, US clinicians can leverage those same transformative results not only for the detection of TB (tuberculosis), but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."

Designed for use on Cepheid's GeneXpert Systems, Xpert MTB/RIF not only detects the presence of MTB-complex DNA, but also mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant (MDR-TB). Patients with multidrug-resistant TB need more intensive and prolonged therapy. Xpert MTB/RIF will enable US clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease, not six weeks later as is the case with standard laboratory methods.

"Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country," said David H Persing, MD, Ph.D., Cepheid's chief medical and technology officer. "About one-third of the human population is infected with TB, but most do not have active disease that requires treatment. Ruling out active disease in TB suspects is a relatively common task of domestic clinical laboratories. We think that the Xpert MTB/RIF test will help to eliminate guesswork and deliver maximum medical value in the management of TB here in the US, as already demonstrated abroad."

Tuberculosis remains a major global health concern, with an estimated 8.7 million new cases reported worldwide in 2011 according to the WHO. Continuing the decline in TB cases in the United States will require sustained focus on domestic TB control activities and further support of global TB control initiatives.

Xpert MTB/RIF is now available for immediate shipment in the US.

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.

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Co-Diagnostics and DNA Logix Form Joint Venture to Address High Burden Developing Countries

Co-Diagnostics, Inc. and DNA Logix announced today that they have reached an agreement to form a joint venture, Co-Diagnostics HBDC LLC, to address diagnostic problems for infectious diseases unique to high burden developing countries (HBDC). It is estimated that while HBDC’s have 90% of the burden of disease worldwide, only about 10% of research and development is devoted to them. Co-Diagnostics HBDC will sell testing products and services to these middle- and low-income countries based on proprietary real-time PCR testing technology developed by DNA Logix and licensed to Co-Diagnostics HBDC specifically for that market.

Co-Diagnostics is a leading DNA testing company and recently acquired the suite of DNA testing technologies from DNA Logix to be used in their joint venture. DNA Logix is the first company to use mathematics to create entirely new forms of diagnostic tests, often with multiple-order-of-magnitude improvements in performance. DNA testing, such as real-time PCR, is the current recommended method for rapid and accurate diagnosis of diseases like tuberculosis, which is estimated by the World Health Organization to afflict roughly one-third of the world’s population, with over 95% of cases existing in developing countries. However, the high cost of DNA tests and the equipment necessary to run them prevent their deployment in many countries around the world.

“The business models that are currently used for diagnostic testing in the U.S. are not the most effective business models in other countries. We are excited to create an entity with the tools and focus necessary to solve problems internationally,” said Dwight Egan, President of Co-Diagnostics.

Dr. Brent C. Satterfield, CEO of DNA Logix, added, “There is a lot of unmet need in the world. We are glad that Co-Diagnostics is engaged in this effort, and we believe that innovative testing technologies, combined with forward-thinking business models, will allow us to reach a much larger number of people.”

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Minnesota Team Develops First PED Virus Rapid Test

University of Minnesota researchers have developed a rapid diagnostic test for porcine epidemic diarrhea (PED) virus, mere months after the viral diease was first confirmed in the U.S. swine population,

The first-of-its-kind test, which is available now, provides a way to quickly and cost-effectively identify the presence of PED virus strains in the United States.

Characterized by acute diarrhea and vomiting, a PED virus outbreak wipes out an average of 50% of young swine at newly affected farms. PED virus poses no risk to other animal or human health and no risk to food safety. Should PED virus become widespread, however, the pork industry could suffer significant losses. The virus has been confirmed in 16 states. There is no known vaccine or treatment for the virus.

Samples from animals suspected of carrying PED virus can be submitted to the University of Minnesota Veterinary Diagnostic Laboratory (VDL) for testing. Test results are known within 24 hours, allowing for pork producers to take necessary precautions to prevent further spread. Genetic material is also extracted from the samples, which can be tested and tracked to monitor PED virus spread.

Samples including swine fecal swabs, saliva, serum, feed, and fecal, intestinal and lung tissues can be tested via a multiplex assay which identifies the presence of not just PED virus, but also transmissible gastroenteritis (TGE) – a known, similar RNA virus. Pairing the tests improves affordability to agriculture by bringing the cost of the test to less than $50.

“The University of Minnesota has been preparing for the arrival of an infectious disease like PED virus by making strategic investments over the past 10-20 years,” says James Collins, DVM, director of the VDL, professor in the College of Veterinary Medicine, and expert in food animal diagnostic medicine and infectious disease. “Agriculture is such an important part of what we do in Minnesota and thanks to preparation and the help of our partners, we were able to mobilize available resources and technology quickly to turn around a new test in just a few months. In our mind, the point where research can move this quickly is the pinnacle of where we need to be.”

In addition to development of the test, the University of Minnesota team has completed sequencing the DNA of one strain of U.S. PED virus. The sequence has been deposited into the GenBank database in the National Center for Biotechnology Information to help amplify the research potential of new PED virus genome understanding.

Development of a cost-effective bioassay to determine whether PED virus is being spread via non-genetic materials including feedstuffs is ongoing at the university. Investigations aim to both identify the presence of PED virus and determine whether it is alive and active, thus posing a risk. The University of Minnesota, in collaboration with the U.S. Department of Agriculture and National Pork Producers Association, also continues to investigate how PED virus first entered the United States and further ways to best limit its spread.

“This is an important new disease that’s entered the United States, and we have to try to mitigate its damage. The University of Minnesota is working diligently to help address the problem,” Collins says.

Collaborators in this project include the University of Minnesota College of Veterinary Medicine, its Swine Disease Eradication Center, Veterinary Diagnostic Laboratory and the University of Minnesota BioMedical Genomics Center.

Funding was provided by the Minnesota Rapid Agricultural Response Fund, the National Pork Board and Zoetis Animal Health.

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Invisible Sentinel to Participate in IAFP Food-Safety Meeting

Invisible Sentinel Inc., a life-sciences company that develops rapid diagnostics for the detection of foodborne pathogens, will showcase its first-in-class Veriflow™ technology at the Annual Meeting of the International Association for Food Protection (IAFP), the leading food-safety conference worldwide.

The Annual Meeting will be held July 28-31 in the Charlotte Convention Center, Charlotte, NC. Senior executives and scientists from Invisible Sentinel will be available throughout the meeting to discuss the Company's technology. The Invisible Sentinel booth will be number 809.

Combining sensitivity and ease of use, Veriflow™ test kits are the first molecular flow-based assays available for use by food producers, processors, distributors, and retailers as well as government health officials.

"Veriflow™ technology can protect food safety at critical points in the food-production and food-distribution network," said Benjamin Pascal, Co-Founder and Chief Business Officer of Invisible Sentinel. "Now that our test kits have entered the market, we look forward to discussing with food companies how Veriflow(TM)can strengthen their food-safety programs."

Veriflow(TM) CA, to detect Campylobacter, and Veriflow™ LM, to detect Listeria monocytogenes, have received Performance Tested Methods(SM) certification from the Association of Analytical Communities International (AOAC). Currently in the AOAC review process for certification are additional Veriflow™ kits to detect Listeria species and Salmonella species. Veriflow™ kits for Shiga toxin-producing Escherichia coli (STEC) are slated for submission later this year.

The IAFP meeting, expected to attract more than 2,500 food-safety experts, provides an opportunity to learn about food-safety issues, the food-science, and technology.

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GeXP Analyzer Detects Foodborne Pathogens

Researchers have modified a device for the detection of selected foodborne pathogens in a single reaction-without any enrichment step.

Zhou et al developed and evaluated a novel application of the GenomeLab Gene Expression Profiler (GeXP) analyzer, which was capable of detecting the presence of multiple pathogens in a
single reaction.

The analytical procedure includes primer design, PCR amplification using both chimeric and universal primers, capillary electrophoretic separation based on the size of the PCR product followed by identification in terms of the expected size.

GeXP Enhancements

The GeXP multiplex PCR amplification condition was improved by using a fixed annealing temperature, including two steps with different annealing temperatures.

Step one in the first 12 cycles was performed at a higher temperature using the gene-specific sequence of the chimeric primers to produce amplicons that have universal tags.

Step two was performed using universal primers at a lower temperature in cycles 13–32. Improved PCR condition enhanced the specificity and sensitivity of multiplex PCR analysis.

Plasmid pMD19 was added to each reaction as positive control to ascertain whether the PCR step and data analysis step of the assay were carried out correctly.

Detection Speed

GeXP method was capable of detecting these six pathogens in four hours (1h for DNA extraction, 2h for PCR amplification, 45min/row of eight samples for capillary electrophoretic separation, and 10min for interpretation).

No non-specific or false-positive results were observed, according to the researchers.

The cost of the method for simultaneous identification of six foodborne pathogens is $10 per test.

GeXP-PCR assay was capable of detecting as low as 101–102 CFU/mL of six pathogens in a single tube without any enrichment steps.

For the analysis of GeXP-PCR assay, the researchers selected six of the representative bacteria associated with foodborne illnesses.

The objective was to develop a rapid, sensitive and high-throughput pathogenic bacteria diagnostic technique using GeXP-based multiplex PCR assay (GeXP-PCR) for simultaneous detection of six foodborne pathogens.

Tested Pathogens

Pathogens targeted were Salmonella enterica, Shigella spp., L. monocytogenes, C. jejuni, Staph. aureus and E. coli O157:H7.

“All six S. enterica strains, all three E. coli O157:H7 strains, four L. monocytogenes strains, four Shigella spp. strains, five Staph. aureus strains, and three C. jejuni strains were positive in the GeXP-PCR assay and all of the non-target organisms were negative in the assay.

“No mispriming or non-specific amplification was observed. None of the reactions generated more than a single peak and peaks of same species with different serotypes were shown in same position.”

The GeXP-PCR detection can combine patented XP-PCR priming strategy with capillary electrophoretic separation, resulting in high levels of specificity, sensitivity and throughput capacity.

With the GeXP, up to 35 genes can be multiplexed in a single reaction. The major advantages of this method include performance, multiplexing capability, and the ability to process samples in parallel.

Further evaluation of the GeXP-PCR assay with more food samples from different sources is necessary to confirm its value and modify the analysis procedures to reduce the number of steps involved, concluded the researchers.

Sources: Food Quality News and Food Control, Volume 32 Issue 1 July 2013 pages 198-204 (Online ahead of print, DOI: 10.1016/j.foodcont.2012.11.044).

“Simultaneous detection of six food-borne pathogens by multiplex PCR with a GeXP analyser”

Authors: Beili Zhou, Jinwen Xiao, Shengfeng Liu, Jun Yang, Yu Wang, Fuping Nie, Qing Zhou, Yingguo Li, Guohua Zhao

Abstract:

A novel application of GeXP analyzer was developed for simultaneous detection of six pathogens associated with food poisoning outbreaks, including Salmonella enterica, Escherichia coli O157:H7, Listeria monocytogenes, Staphylococcus aureus, Shigella spp., and Campylobacter jejuni. Chimeric primers containing both microbe- and pMD19-specific sequences were fused to universal sequences resulted in PCR products with intended sizes. The PCR products were separated by capillary electrophoresis and identified by using fluorescence spectrophotometry. Plasmid pMD19-T was added to each reaction as positive control to ascertain the PCR steps and data analysis step of the assay. The results indicate that the GeXP method is both specific and sensitive for the detection of all six food-borne pathogens in a single reaction-without any enrichment step. In conclusion, the GeXP-PCR assay is a rapid, sensitive and high-throughput method for parallel analysis of food-borne pathogens.

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Seegene Develops Novel Real-Time Array Technology for Point of Care Testing

Seegene Inc., a leading developer of multiplex molecular diagnostic technologies and tests, today announced a novel real-time array technology designed specifically to accelerate the development of Point of Care Testing (POCT).

The novel real-time array technology successfully eliminates burdensome, time-consuming steps that normally follow PCR amplification, and that are required for conventional arrays. For example, the new technology unifies all the steps into one, facilitating rapid, reliable, and reproducible real-time array tests. The underlying chemistry of the new technology easily adapts to automated systems; is easy to streamline and standardize for molecular diagnostics; and is highly applicable to array-based POCT.

"The multiplexing capability of arrays to detect and differentiate many targets in parallel is critical. We are advancing on these benefits by enabling an array to reliably detect many targets without requiring many burdensome steps. This is a significant development for the use of arrays in molecular diagnostics, and a key enabler of array-based POCT," said Dr. Jong-Yoon Chun, founder, CTO and CEO of Seegene.

Key features of this array technology include:

• No size limitation for the PCR amplicon
• No Asymmetric PCR required
• No Denaturation of PCR amplicon
• No Target Specific Primer Extension (TSPE)
• No Signal Amplification
• No Washing Step

Dr. Chun added, "Our new real-time array technology will be made widely available to support new molecular diagnostic applications that provide improved patient care and healthcare cost savings. This real-time array technology can strengthen the businesses of traditional diagnostic companies, and create new opportunities for other life sciences firms to be competitive in the molecular diagnostics industry. That is why we are initiating an aggressive licensing and OEM campaign to make this technology broadly available to a broad segment of the life science industry."

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DxNA Acquiring PathoGene in MRSA MDx-Centric Deal

St. George, UT-based molecular diagnostics firm DxNA is slated to acquire PathoGene, a company that develops PCR-based infectious disease diagnostics and is headquartered in Flagstaff, AZ, for an undisclosed price.

Announcing an agreement through which DxNA gains exclusive rights for Unit Dose Platform Applications of PathoGene’s “next-generation” multiplexed Staphylococcus MRSA+ assay on DxNA’s Real Time PCR GeneSTAT platform this week, the firms also said they had signed a letter of intent signaling the Utah company would buy the Arizona firm outright.

“In addition to testing for MRSA, PathoGene’s assay also detects multidrug resistant coagulase-negative Staphylococcus strains, which are actually much more common infections than MRSA. This is a significant step forward compared to current diagnostic methods and allows the assay to rapidly identify and differentiate three of the most common pathogens of hospital acquired infections…in a single multiplexed assay,” Todd Snowden, the firm’s president and CEO, said in a statement. “This provides information to physicians in about an hour that is critical to treatment decisions that save lives, improve patient outcomes and reduce treatment costs.”

Added DxNA President and CEO David Taus: “PathoGene’s novel approach with this Staph assay provides rapid clinical answers that impact patient care, costs and outcomes making the assay an ideal complement to our GeneSTAT platform.”

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Sequencing Quickly Identifies Resistant TB

Whole-genome sequencing offers a means of rapid characterization of multidrug-resistant tuberculosis to guide clinical decision-making, according to authors of a case report.

Investigators obtained DNA from a sputum sample that became culture-positive after 3 days in a mycobacterial growth indicator tube. Whole genome sequencing identified two distantly related Beijing strains of Mycobacterium tuberculosis.

Standard genotyping did not identify mixed infection on three additional samples from the same patient.

"These findings have important implications for distinguishing relapse from reinfection and for identifying secondary cases of infection," Sharon J. Peacock, PhD, of the University of Cambridge in England, and co-authors stated in correspondence to the New England Journal of Medicine.

Researchers analyzed genes with known resistance to 39 different antibiotics. Results from a reference laboratory showed phenotypic resistance to nine drugs. Susceptibility was demonstrated for amikacin, capreomycin, clofazimine, and linezolid, findings consistent with genotyping, the authors said.

Genomic sequencing also revealed mutations consistent with resistance to several agents not tested by the reference laboratory: amithiozone, gatifloxacin, levofloxacin, rifapentine, and rifabutin.

Susceptibility to para-aminosalicylic acid was indicated, consistent with the majority strain. However, the minority strain harbored a mutation involved in the activation of the drug, with unknown consequences.

"This retrospective study revealed the potential of rapid whole-genome sequencing to reduce the time taken to diagnose [multidrug resistant] tuberculosis from weeks to days, depending on the time to culture positivity and the turnaround time for sequencing and analysis," the authors concluded. "In well-resourced countries, rapid whole-genome sequencing may replace current methods of identifying and typing M. tuberculosis complex, since it offers the ultimate molecular resolution for outbreak investigations."

Whole-genome sequencing cannot replace phenotypic susceptibility for all antibiotics, they added, but can be used for rapid identification of resistance when mutations associated with resistance are detected.

Reference:

Peacock S "Whole-genome sequencing for rapid susceptibility testing of M. tuberculosis" N Engl J Med 2013; DOI: 10.1056/NEJMc1215305.

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Quidel Obtains Special 510(k) Clearance to Add Avian Influenza A (H7N9) Virus Analytical Reactivity Information

Quidel Corporation, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, received Special 510(k) clearance for an update to the Company's immunofluorescence-based Sofia(R) Influenza A+B FIA package insert to include analytical reactivity with an avian Influenza A (H7N9) strain, A/Anhui/1/2013, on July 5th, 2013. Clearances of additional Special 510(k)s for its QuickVue(R) Influenza A+B and QuickVue Influenza visually read tests were also granted (June 28th and July 5th, respectively). The package inserts for all three products are being updated accordingly.

The novel influenza A (H7N9) virus is an avian influenza virus that has been shown to infect people in close contact with infected birds. In China, according to the CDC, approximately 130 people are known to have been infected with this virus and as of May 30, thirty-six (36) have died.(1) This virus is an avian influenza virus and is not readily human-to-human transmissible, but it is a high risk virus with pandemic potential. So far, no human cases have been identified outside of China.

The Sofia Influenza A+B FIA and both QuickVue influenza tests have been shown to detect the cultured A/Anhui/1/2013 virus analytically. However, the performance characteristics of these devices with clinical specimens from people that are positive for the A/Anhui/1/2013-like influenza A (H7N9) infection have not been established. The Sofia Influenza A+B FIA and the two QuickVue influenza kits can detect influenza A viruses, including this novel avian virus, but they cannot differentiate influenza A subtypes -- i.e., they cannot specifically identify this novel avian A (H7N9) or other avian or human influenza A subtypes.

Douglas Bryant, Quidel's president and chief executive officer, commented, "The first human infection with the novel avian influenza A (H7N9) was reported in China on April 1, 2013 -- only three and one half months ago.(1) The ability of the WHO, our U.S. regulatory and public health agencies, and our industry to react so quickly to dangerous, emergent viruses is an essential element of public health in the future, especially given the rapidly growing population and profound interconnectivity of the world's people made possible by rapid, comparatively inexpensive travel and commerce. Rapid tests, when used appropriately and correctly," Mr. Bryant added, "are useful tools in the effort to help diminish the spread of influenza. Quidel will continue to be alert to the advent of emergent influenza viruses with the intention of being poised to respond to important public health initiatives."

(1) http://www.cdc.gov/flu/avianflu/h7n9-virus.htm, as of July 12, 2013.

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Funding Awarded to Detect E. Coli in Food Processing Facilities

Genome Alberta is pleased to announce on behalf of our funding partners the Alberta Livestock and Meat Agency, Alberta Innovates Bio Solutions, Genome Canada, Genome Quebec, and the Ontario Ministry of Agriculture and Food and the Ministry of Rural Affairs, the results of our collective funding competition for the rapid detection of pathogenic E.coli. Each of the two successful applications will receive $500,000 in new funding. The successful projects will leverage this investment with additional funding to bring the total investment to $1.6 million over the 18 month life of the projects.

The first project receiving funding is titled "Rapid Sampling and Detection of STEC in Meat" and is led by researchers Linda M. Pilarski and Lynn McMullen from the University of Alberta. The second project receiving funding is titled "Point-of-Need Gene-Based System for Detection of Priority STEC in Beef" and is led by researchers Michel G. Bergeron of Université Laval and of Centre de recherche du CHU de Québec (affiliated with Université Laval) and Burton W. Blais with the Canadian Food Inspection Agency.

The competition was launched by the funders in November of 2012 with the main objective of developing an innovative genomics based test for the presence of generic and pathogenic E.coli bacteria during food production. The funders expect that the research effort will result in new genomic-based detection methods that can be used in industry settings, and that is more sensitive, faster, and cheaper than currently available technologies.

The desired criteria for the new detection methods were developed with input from industry on the practical and business aspects, and from government to ensure the methodology being developed will meet regulatory requirements. All applications were evaluated by an independent peer review panel comprised of industry and science experts.

Each of the successful projects will leverage this investment from the funders with additional funding to bring the total investment to $1.6 million over the 18 month life of the projects.

Genome Alberta is a publicly funded organization that initiates, funds, and manages genomics research and partnerships. We were established in 2005 as part of Alberta's Life Sciences Strategy through an initiative between the Alberta Government and federally funded Genome Canada.

Alberta Innovates Bio Solutions is a board-governed research agency funded by the Government of Alberta. We invest in science and innovation to grow prosperity in Alberta's agriculture, food and forest sectors. We routinely work with R&D partners on research and innovation projects in the areas of sustainable production, bioeconomy, food innovation, ecosystem services and prion.

Genome Canada is a not-for-profit organization that invests in genomics research to generate economic and social benefits for Canadians. Genome Canada builds bridges between government, academia and industry to forge a genomics-based public-private innovation enterprise focused on key life science sectors. We develop these partnerships to invest in and manage large-scale research and translate discoveries into commercial opportunities, new technologies, applications and solutions.

PROJECT SUMMARIES

Rapid Sampling and Detection of STEC in Meat

Pathogen contamination in meat has a very significant economic impact on the meat industry and a serious health impact for the public. At the University of Alberta, Drs. Linda Pilarski, Lynn McMullen, Michael Gänzle and Patrick Pilarski will collaborate with Dr. Xianqin Yang from the Lacombe Research Centre. They will modify an existing molecular testing platform for rapid detection of pathogenic E. coli. This novel platform requires minimal capital equipment, can be used by existing staff and completes the testing in under an hour, using machine intelligence to report results. The project will adapt miniaturized technology that needs only minimal human intervention, to produce a commercially viable test that meets the requirements of health regulators. Because fast turnaround testing requires a faster sampling method to prepare meat for testing, the Pilarski-McMullen research team will also develop improved sampling strategies. Its speed, capacity, and cost make this platform well suited for regular on-site testing in abattoirs and meat processing plants. This will reduce the time and cost for identification of pathogenic bacteria during meat processing and in meat products. It will help to safeguard the consumer health and enhance food safety systems.

Point-of-Need Gene-Based System for Detection of Priority STEC in Beef

The intent of the STEC7 project undertaken by the research consortium assembled by Drs Bergeron and Blais is to develop a novel test method enabling the detection of less than 10 Shiga toxin- and verotoxin-producing E.coli (STEC) cells present in 325 g of ground or trim beef, by real-time PCR in less than 8 hours, such that E.coli-free production lots can be marketed more rapidly. The STEC7 panel, composed of seven E.coli serotypes, is a top priority of food inspection agencies in Canada and the United States of America.

To achieve this, the research team will:

• Improve the enrichment medium currently used 
• Develop a compact and industry-friendly sample preparation strategy to efficiently recover E. coli cells from an enriched culture within 6 hours 
• Deliver the concentrated cell suspension to a microfluidic device and an easy-to-use automated instrument, developed in Dr Bergeron's laboratory and now commercialised by GenePOC Inc. of Québec City, capable of detecting target E. coli in less than one hour. The efficiency, performance, and user-friendliness of the methods, tools, and GenePOC instrument will be assessed by food testing laboratories of the federal government and the private sector. 

SOURCE: Genome Alberta

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BioMérieux, Ultimate Labs Partner on Mass Spec-based Microbial Identification

bioMérieux, a world leader in the field of in vitro diagnostics, is pleased to announce it has joined with Ultimate Labs, a leader in the safe production and quality control of food, drugs, and medical devices, to provide the industry with VITEK® MS - the most rapid mass spectrometry method available to detect microbial pathogens in food and pharmaceutical production.

VITEK MS, uses MALDI-TOF mass spectrometry technology to identify bacteria, yeast, and mold, offering significant time savings with respect to traditional identification methods. It is also extremely sensitive, providing a standard of accuracy above many of the current state-of-the art techniques.

“We are extremely pleased to bring this state-of-the-art technology to our customers,” said Kim Lim, CEO of Ultimate Labs. “Our clients adhere to strict safety and quality control regulations issued by governmental agencies such as the USDA and the FDA, and have to be compliant with industry standards. Also, they are eager to identify potential contaminants faster and to increase the sensitivity of their testing. The quantitative protein profiling provided by VITEK MS allows a greatly improved accuracy and time-to-results for our customers," Ms. Lim added. "For our clients where results impact products with short shelf-lives, the faster we can get results to them, the better.”

Bacterial and mold identification are crucial to confirm contaminations and to guide corrective actions in the production of consumable products made by pharmaceutical, cosmetic, and food manufacturers. With 50 years of experience in microbial identification, bioMérieux is the only microbiology company offering a mass spectrometry solution for industry needs. VITEK MS provides fast, flexible, and robust results, and can provide an identification of a microorganism’s genus and species in just a few minutes. As the world leader in microbiology, bioMérieux pairs VITEK MS system with the most comprehensive microbial database in the business.

“Reference laboratories today are striving to improve productivity and shorten their time-to-results,” said Pierre-Louis Thiney, Executive Director US Industry for bioMérieux. “Providing a fully integrated, rapid solution for microbial identification is a significant step in providing timely and accurate results to the customer.”

VITEK MS is available for industrial use and has been submitted for marketing clearance to the FDA for the clinical market.

About MALDI-TOF Mass Spectrometry

In the MALDI-TOF* process, the sample to be analyzed is mixed with another compound, called a matrix. The mixture is applied to a target slide, placed inside the instrument, and irradiated with a laser. The matrix absorbs the laser light and vaporizes, along with the sample, in the process gaining an electrical charge (ionization).

Electric fields then guide the ions into the flight tube, which separates them according to ‘weight’ (mass) and displays the results as a series of lines (spectrum) which correspond to different fragments that have broken away from the original molecule. By analyzing the pattern of fragments, it is possible to deduce the structure of the molecule.
VITEK MS takes this further by comparing the sample spectrum to an extensive database of spectra from bacterial species to allow the system to accurately identify the microorganism in question.

*Matrix Assisted Laser Desorption/Ionization Time-Of-Flight

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Last Chance to Register for the Introduction to Rapid Micro Methods Webinar - July 15

The implementation of rapid methods is increasing in many areas, including pharmaceutical manufacturing and QA/QC. Additionally, global regulatory authorities, such as the FDA and EMA, have embraced their use and stated that these new technologies will improve product quality and patient safety. And many companies have successfully implemented RMMs as alternatives to USP micro methods. 

A new, comprehensive 90-minute webinar provides an introduction to the world of rapid methods and their scientific principles, applications, validation strategies, return on investment, and how to navigate the current regulatory environment. This is an excellent overview that will provide attendees with the framework for implementing rapid methods at their own facilities.

DATE: Next Monday, July 15, 2013.

TIME: There are five (5) identical webinar sessions to accommodate most geographic locations.

REGISTER HERE: http://rapidmicromethods.com/events/July-15-2013-webinar-RMM-Intro-registration.php

KEY LEARNING POINTS:

• Review the benefits of alternative and RMM technologies as compared with classical microbiological methods.
• Opportunities for use and areas of application including microbial detection, quantification and identification.
• Quality enablers and current regulatory perspectives.
• Introduction to validation strategies.
• Overview of how to develop a business plans based on return on investment calculations.
• Describe the scientific basis for available RMM technologies.
• Review published and online information and guidance related to RMMs.

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Researchers Create Novel Sequencing Technique to Rapidly Identify Disease-Causing Pathogens

Researchers from Boston University School of Medicine (BUSM) and George Washington University (GWU) have developed a method to rapidly identify pathogenic species and strains causing illnesses, such as pneumonia, that could help lead to earlier detection of disease outbreaks and pinpoint effective treatments more quickly. The findings are featured online in the journal Genome Research.

Emerging sequencing technologies have revolutionized the collection of genomic data for bioforensics, biosurveillance and for use in clinical settings. However, new approaches are being developed to analyze these large volumes of genetic data. Principal investigator Evan Johnson, PhD, assistant professor of medicine at BUSM, and Keith Crandall, PhD, director of GW’s Computational Biology Institute, have created a statistical framework called Pathoscope to identify pathogenic genetic sequences from infected tissue samples.

This unique approach can accurately discriminate between closely related strains of the same species with little coverage of the pathogenic genome. The method also can determine the complete composition of known pathogenic and benign organisms in a biological sample. No other method can accurately identify multiple species or substrains in such a direct and automatic way. Current methods, such as the standard polymerase chain reaction detection or microscope observation, are often imperfect and time-consuming.

“Pathoscope is like completing a complex jigsaw puzzle. Instead of manually assembling the puzzle, which can take days or weeks of tedious effort, we use a statistical algorithm that can determine how the picture should look without actually putting it together,” says Johnson. “Our method can characterize a biological sample faster, more accurately and in a more automated fashion than any other approach out there.”

This work will be relevant in a broad range of scenarios. For example, in hospitals, this sequencing method will allow for rapid screening of thousands of infectious pathogens simultaneously, while being sensitive enough to monitor disease outbreaks caused by specific pathogenic strains. Veterinarians can even apply the method in their practices. This research is also applicable outside of clinical settings, allowing officials to quickly identify agents of bioterrorism (e.g., in a tainted letter) and harmful pathogens on hard surfaces, soil, water or in food products.

“This approach has the ability to drastically change the process for identifying and combating pathogens, whether they’re in a hospital, veterinarian’s office or salmon stream,” Crandall says. Researchers plan to conduct more studies to further verify the efficacy of their approach, and will soon begin to work with the aquaculture industry, helping fishermen with water-quality surveillance.

Funding for this research was provided in part by the National Institutes of Health’s (NIH) National Human Genome Research Institute under grant award number R01HG00569.

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New Genotyping Technology for Rapid Strain Typing WIll Debut at Annual Food Protection Meeting

PathoGenetix will introduce the RESOLUTION Microbial Genotyping System at the 2013 International Association for Food Protection (IAFP) Annual Meeting this month and present new research demonstrating the technology’s rapid serotyping and strain typing capabilities. The RESOLUTION System, which identifies pathogens directly from enriched food samples in five hours and provides strain level resolution comparable to PFGE, will be available in 2014 for use in food safety testing and foodborne illness outbreak investigations.

PathoGenetix™, Inc., a commercial-stage developer of an automated system for rapid bacterial identification, will participate in the 2013 International Association for Food Protection (IAFP) Annual Meeting taking place in Charlotte, North Carolina, from July 28-31. A sustaining member of IAFP, PathoGenetix plans to demonstrate its new RESOLUTION™ Microbial Genotyping System for the first time at the meeting, and to present two new research studies detailing the differentiation and typing of Salmonella strains, from both pure culture and complex “presumptive positive” food samples, in five hours.

The IAFP Annual Meeting provides information on current and emerging food safety issues, and is the leading food safety conference worldwide. The conference addresses the latest science and solutions on new and recurring issues in food safety, and includes technical papers, posters and symposia on a variety of topics related to food safety.

The RESOLUTION Microbial Genotyping System is based on PathoGenetix’s proprietary Genome Sequence Scanning™ (GSS™) technology, a breakthrough in microbial identification with significant advantages for food safety testing and outbreak investigations. GSS works directly from complex mixtures such as enriched food samples or from pure culture isolates, and automates the identification process from sample preparation to data analysis. As a result, the RESOLUTION System can provide actionable information in five hours, days faster than current identification methods, and offer food producers a valuable new tool for identifying house strains or conducting traceback analysis.

The RESOLUTION System also provides public health labs and government agencies the potential for faster source tracking in foodborne illnesses outbreak investigation. The typing resolution of GSS is comparable to PFGE, the current standard for pathogen identification in outbreak investigations. Yet because the technology works in mixed culture, it can provide critical strain information in a culture independent diagnostics environment. The System’s automated platform and simplified protocol require minimal training, and strain type results can be quickly and easily shared across laboratory networks.

PathoGenetix will exhibit the RESOLUTION System at IAFP beginning on Sunday, July 28, at 7:30 PM and continuing through Tuesday, July 30, at 6:00 PM.

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InstantLabs Receives AOAC Certification for Its Listeria monocytogenes Kit

InstantLabs Medical Diagnostics Corporation (InstantLabs®), developer of the portable Hunter Accelerated Real-Time PCR® system, today announced that its Listeria monocytogenes (L. mono) Food Safety Kit has received AOAC Performance Tested Methods(SM) certification (PTM #051302) for environmental and food matrices. The company also announced the release of new software with enhanced features which further simplify and streamline the food safety testing and reporting process.

The Hunter system is a real-time polymerase chain reaction (RT-PCR) platform that provides rapid, affordable, and accurate detection of pathogens. InstantLabs' L. mono Food Safety Kit has been certified for the identification of L. mono in foods and environmental surfaces that are common carriers of the potentially lethal foodborne pathogen. The award follows independent laboratory studies conducted by Food Safety Net Services (FSNS). The AOAC Performance Tested(SM) certification mark is widely recognized by the food industry and government agencies and is awarded to products that have passed unbiased and rigorous evaluation.

InstantLabs' Hunter system is easily integrated into food production facilities' HACCP programs. The compact, affordable and easy-to-use system is available worldwide, and comes "ready to use." The latest software release provides immediate notification of results with the ability to automatically email test reports at the completion of the run, allowing for more rapid release of product to the market.

"We are amazed at how easy it is to set up and integrate the Hunter System into food manufacturing processes," said Cesur Ergun, of the Tetra Group. "The system's minimal steps and user friendly color coding for tracking results allows processors to rapidly and confidently conduct food safety testing without errors."

"We are excited to receive this AOAC certification, and look forward to developing more test kits to address the needs of the food industry," said Steven Guterman, Chief Executive Officer of InstantLabs. "Our ongoing commitment to our customers led to the development of the latest version of the Hunter's integrated software. Users can now have test results emailed directly to key personnel following completion of testing. The Hunter is continuously being refined to be a product that is both cutting edge and practical for this dynamic market."

The bacterial genus Listeria is an increasingly prevalent and dangerous global food pathogen, and can be found in foods as diverse as dairy, produce, meat, and poultry products. Contamination by Listeria can happen at any point in the food processing chain, making it important to test final food products as well as the environment including surfaces and machinery along the entire food processing line. Recent instances of Listeria contamination in the United States include a multistate outbreak of listerosis linked to whole cantaloupes in 2011 which resulted in 30 deaths.

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3M Food Safety Announces Molecular Detection Assay for Listeria monocytogenes

3M Food Safety today announced the launch of its new 3M™ Molecular Detection Assay Listeria monocytogenes. This is the fourth test available for the award-winning 3M™ Molecular Detection System, which provides pure and simple testing for dangerous pathogens in a variety of food matrices.

The 3M Molecular Detection System is a breakthrough for the food and beverage industry. The 3M Molecular Detection Assays use isothermal amplification of nucleic acid sequences, plus bioluminescence to detect the amplification. Presumptive positive results are delivered in real-time while negative results are displayed after the assay is completed. The system is an innovative solution that is fast, cost-effective and easy to use, without sacrificing sensitivity or specificity.

“Listeria monocytogenes is a highly dangerous pathogen that remains a serious concern in the food processing industry, so we are pleased to offer such a simple and reliable solution for detecting it,” said Niki Montgomery, global marketing and development manager for 3M Food Safety.

The 3M Molecular Detection System was introduced to food processors, third-party reference laboratories and other customers in December 2011. The rapid, qualitative technology is applied to enriched food as well as food process samples.

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Rapid Tests Under Development Improve Pathogen Testing of Foods

Advances in pathogen testing are coming soon, according to Trevor Suslow, extension research specialist for preharvest to post-harvest produce safety at the University of California-Davis.

“We’re trying to develop a rapid system or index for assessing the likelihood that pathogens will be present,” Suslow said.

In fact, Suslow says several systems are in development.
“Everyone’s searching for a validated approach for predicting food safety,” he said.

In particular, listeria is at the forefront of many industry discussions.
“We get a lot of questions of listeria contaminations, and what it takes to be compliant with the increasing expectations of retailers and buyers,” Suslow said.

United Fresh is taking the lead in pulling together a white paper that will be released shortly, according to Suslow. The goal is to present a sort of how-to manual for the industry, in which best practices for prevention and environmental monitoring of listeria are detailed.

New testing systems

These systems focus on delivering answers faster.

“You have to have an answer on if pathogens are present before you ship, so the latest advancements are in the sensitivity of the detection,” Suslow said.

“These new testing systems focus on placing the samples in an enrichment culture to help encourage those pathogens to multiply and increase in number so they can be more easily detected,” he said. “You are basically just growing enough of what may be present so you can more easily detect it.”

Then, there are several techniques to sort out any potential pathogens.
“There are a number of creative and sophisticated systems, either using magnetic or specially formulated viruses that will attach to something like E. coli or salmonella,” Suslow explained.

These processes will help to reduce the amount of time needed for labs to come to a conclusion on whether the sample needs to be rejected or accepted.

In some cases, traditional tests may have taken somewhere between three and four days, whereas these new rapid systems can have results in 12-24 hours.

Suslow said there are other various lab techniques and specifics that can affect the specific time each test takes to finish.

For example, listeria, which grows slower, needs to be grown for 20-24 hours to prevent what Suslow calls a false negative, while E. coli or even salmonella can be detected in about 12 hours.

Still, the improvements are noticeable.

“If you are going to be testing, there are much better platforms out there now than there have been for the last couple of years,” he said.

Of course, Suslow doesn’t want everyone to immediately start testing using this new system in hopes of avoiding an outbreak situation.

For one thing, it can be costly and time consuming for growers to do this, despite that the more tests that are done, the more cost effective each one becomes.

Prevention’s best

Instead, Suslow said he thinks contamination is really best if it’s simply prevented in the first place.

“Testing for pathogens won’t give you any better results than if you just have a well-managed, audited food safety system in place,” he said.
In cases where an issue or a specific case does arise, that’s when Suslow said pathogen testing is most effective.

“If a situation comes up, and you want to try and assure it doesn’t represent an actual contamination, that’s where I’d recommend you spend the target dollars to pathogen test,” he said.

He also said the industry needs to continue to work on evaluating environmental testing in packing facilities, which already is becoming more widespread at fresh processing locations.

Source: The Packer, Everything Produce 

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PathoGenetix, Applied Maths to Integrate Rapid Strain Typing and Bioinformatics Tools

PathoGenetix, Inc., a developer of an automated system for rapid bacterial identification, and Applied Maths, NV, a leader in bioinformatics and analytical solutions for public health and research laboratories, have signed an agreement to link the Resolution Microbial Genotyping System with the BioNumerics software suite to offer a dramatically improved time-to-answer and shortened decision making time in pathogen outbreak investigations, traceback and epidemiological response. The fully automated and integrated solution will confirm and identify pathogens in complex mixtures in just five hours, allow rapid sharing of outbreak information among public health and food safety laboratories, and enable comparison to strain data from other typing systems such as pulsed field gel electrophoresis (PFGE).

The end-to-end automated solution will integrate rapid pathogen strain typing with advanced data management and networking tools, and enable sharing and comparison of outbreak strain data among public health or food safety testing labs. The collaboration also will enable serotype and strain type information generated by the Resolution  System to be compared to data sets generated by other identification methods such as pulsed field gel electrophoresis (PFGE) or whole genome sequencing (WGS).

PathoGenetix’s Resolution  System is based on Genome Sequence Scanning (GSS) technology initially developed to detect bio-threat pathogens in environmental samples. This breakthrough genotyping technology isolates and analyses microbial DNA directly from complex mixtures, without the need for a pure culture. Rapid throughput scanning and proprietary software generate genomic barcodes based on the underlying sequence, and compare them to an onboard database to provide molecular serotype and strain type information for all target bacteria present in the sample at detectable levels.

The typing resolution is comparable to PFGE, the current standard for pathogen identification in foodborne illness outbreak investigations. The Resolution System’s ability to work from a mixed sample could enable it to provide critical strain information in a culture independent diagnostics environment.

“The Resolution System with BioNumerics software will offer public health and food testing labs the ability to seamlessly integrate, curate and compare new outbreak strain information with their existing PFGE and whole genome sequence data sets,” said PathoGenetix president Ann Merrifield. “With time-to-results reduced to just five hours, and a seamless connection to existing strain databases and laboratory tools, we can shorten outbreak investigation and response, and improve public health,” Merrifield said.

Applied Maths’ BioNumerics is a turnkey software suite for integrative biological data management and comparative analysis that includes data mining, clustering, identification and statistical applications. BioNumerics software is currently in use in thousands of public and private research sites and laboratories worldwide, and is the cornerstone for numerous national and international research projects and epidemiological surveillance networks.

“We’re excited to work with PathoGenetix to link its breakthrough microbial identification technology with the BioNumerics software suite,” said Koen Janssens, chief executive officer of Applied Maths. “By working directly from a complex sample rather than a cultured isolate, and by automating pathogen identification from sample preparation to data analysis, our integrated pathogenic organisms in epidemiological investigations.”

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Zyomyx Receives Financing to Enable Launch of Low-Cost, Rapid Point-of-Care CD4 Test for HIV

Zyomyx, Inc. announced that it completed the first closing of its Series 2 Preferred financing totaling US$12 million. The financing was led by Mylan Inc. at approximately US$6 million and included conversion of certain existing funding from the Bill & Melinda Gates Foundation.

Zyomyx concurrently entered an exclusive developing world distribution agreement with Mylan for its proprietary point-of-care (POC) CD4 T-cell count test for HIV patients, the first product developed using Zyomyx's novel platform technology. The test will be available after regulatory approvals.

"We are extremely pleased that Mylan agreed to lead our Series 2 Preferred financing, which will be used to fund initial regulatory approvals and production capacity for our CD4 test," said Peter Wagner, President and CEO of Zyomyx. "The investment underscores the value of both our CD4 test and our proprietary technology, which enables rapid cell capture and counting for a wide range of cells, with potential applications for numerous other human diagnostics and life science markets."

The Bill & Melinda Gates Foundation previously awarded Zyomyx grants through a global initiative for CD4 product development, from which Zyomyx's test emerged as the initiative's most promising technology for use in developing countries at that time. The foundation has since provided additional investments directly to Zyomyx for product development and evaluation trials in Africa.

According to revised World Health Organization guidelines, close to 26 million HIV patients globally are receiving or eligible for antiretroviral therapy. A major barrier to initiating and monitoring treatment among these patients is the inaccessibility of rapid point-of-care diagnostics that can determine a patient's CD4 count, a critical measure of immune system strength, in a single clinical visit. Zyomyx's novel, quantitative and cost-competitive CD4 test was designed to meet this need. The disposable test cartridge is as easy to read as a thermometer; is durable and portable; and delivers results less than 10 minutes from sample collection without requiring expensive laboratory machines.

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Rapid Micro Biosystems Secures $32.6 Million in Financing

Rapid Micro Biosystems, a leading provider of automated,non-destructive, rapid microbial detection for quality control testing within the pharmaceutical and personal care products market segments, today announced that it has raised 32.6 million in series B financing. The funding will be used to expand the commercial and manufacturing operations in support of the Growth Direct(TM) System and the companion applications including: environmental monitoring,sterility and bioburden testing. Providing faster results from quality control testing allows drugs to be produced and released more quickly, economically and safely.

Longitude Capital and TPG Biotech led this financing round with continued participation from Kleiner Perkins Caufield & Byers, TVMCapital and Quaker Partners. Dr. Mark Braganza, Principal at TPGBiotech and Dr. David Hirsch, Managing Director at Longitude Capital will be joining the Rapid Micro Biosystems' board of directors.

"We are excited to be part of a company that offers such a compelling value proposition -- both in automation and testing speed -- to pharmaceutical, biotech and personal care product companies," saidDr. Braganza.

"The Growth Direct(TM) system offers an innovative approach to microbial detection and enumeration, allowing quality control microbiologists to focus on higher value activities," said Dr.Hirsch. "We are pleased to play a role in their expansion."

The Growth Direct(TM) is the only system on the market where all the applications can be run both concurrently and automatically on a single instrument. The system provides results starting within just hours; sending problem alerts so that decision-making and remedial action can start immediately. Leveraging an already proven detection technology, the Growth Direct(TM) delivers exceptional enhancements to productivity, faster response time and reduction in errors.

"These unique capabilities provide an attractive return on investment for our customers and getting drugs to market faster ultimately benefits patients," said Steve Delity, President and CEO. "Our new investment partners, along with our current investors, position Rapid Micro Biosystems to meet the customer requirements for automated microbial detection and enumeration."

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Milwaukee Area Researchers Have New, Faster Test for Sepsis

Researchers in the Milwaukee area have developed a new automated test to identify most leading causes of bacterial bloodstream infections 42 hours faster than conventional methods, potentially reducing medical bills by about $21,000 for patients suffering from sepsis.

The automated nucleic acid test, developed by researchers at Froedtert Hospital & The Medical College of Wisconsin and acompany called Nanosphere, identifies genetic information of bacteria and antibiotic resistance for 12 of the most common bacteria that cause sepsis.

Sepsis caused by bacterial bloodstream infections results in up to 500,000 hospitalizations each year and accounts for 11% of intensive care unit admissions in the United States, according to a study released Tuesday evaluating the effectiveness of the new test. It has a mortality rate of 25% to 80% in critically-ill patients. Gram-positive bacteria — which differ from gram-negative bacteria because of their thick cell walls — account for 52% to 77% of all bacterial sepsis.

Researchers for the study, published Tuesday in the journal PLOS Medicine, collected and tested 1,252 blood cultures containing gram-positive bacteria at five clinical centers across the country, including the Medical College of Wisconsin in Wauwatosa, between April 2011 and January 2012. An additional 387 contrived blood cultures with bacterial targets that are uncommon in the United States were included to further evaluate the performance of the test, named the Verigene Gram-Positive Blood Culture Test.

"We had looked at diagnosis of bloodstream infections and one of the major limitations ... was that results were taking a great deal of time to get to the patient," said the study's lead author, Nathan Ledeboer, an associate professor of pathology and medical director of microbiology and molecular diagnostics at Froedtert and the Medical College of Wisconsin. "What this panel allows us to do is look at a large percentage of those organisms and to report on a number of different resistance factors."

When compared with the commonly used reference culture method, the accuracy of the test — in terms of the number of true positives and negatives — ranged from 92.6% to 100% for all 12 of the gram-positive bacteria in the 1,157 collected cultures that contained a single target. About 7.5% of the cultures contained organisms that were not included on the panel.

Conventional methods take about three days to produce bacterial identification and antibiotic resistance results after the blood culture turns positive; the new test delivers the same results within 2.5 hours. Because of the long incubation period, patients with bloodstream infections are routinely treated with a broad spectrum of anti-microbials that are sometimes ineffective, leading to extended hospital stays.

While other techniques deliver results in as little as 30 to 60 minutes after blood culture positivity have been developed, most are limited to looking at just one milliliter of blood and thereby only one or a few specific target bacteria. The Verigene system can parse through 20 to 40 milliliters of blood and identify 12 gram-positive bacterial targets and three genetic markers of antibiotic resistance directly from the positive blood cultures, Ledeboer said.

"We're getting ready to use it," said Gary Procop, chair of molecular pathology at the Cleveland Clinic. "It gives a rapid identification of the organism and key resistant factors which is really important in tailoring therapy."

He added that the Verigene test is more user-friendly than the faster tests, because it's automated.

Froedtert has used the test for about 500 patients since the Food and Drug Administration approved it in September — and it's worked "exceedingly well," Ledeboer said.

The Verigene testing device itself costs between $10,000 and $20,000, and cartridges for individual blood cultures cost $75 each.

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Blackpool Hospitals Use Genetic Testing to Reduce MRSA

Blackpool Teaching Hospitals NHS Foundation Trust has introduced rapid screening for the superbug MRSA of all emergency admissions patients, and both MRSA and MSSA for surgical patients admitted through A&E.

The Trust uses the BD GeneOhm Assay, an in vitro diagnostic test that uses nasal swabs in patients at risk of colonisation. The technology used in the assay is rapid polymerase chain reaction (PCR) testing method that enables identification of the infection through its DNA.

The test gives definitive results in just two hours as opposed to the two to five days associated with traditional culture methods. This enables timely reporting, aides the clinical decision making process and ensures that high standards are maintained, costs are dramatically reduced and healthcare associated infection (HAIs) are kept to a minimum.

Pilot study

The Trust carried out an initial 12-month pilot study of screening all emergency patients using the rapid PCR testing method. The results saw the number of MRSA bacteraemia fall dramatically from the pre-study to pilot study period, and demonstrated clinical benefits & economic advantages of using rapid screening techniques.

In August 2010 the programme was extended to include MSSA (methicillin-sensitive Staphylococcus aureus) for all surgical patients admitted through A&E. Preliminary data also shows a significant drop in MSSA bacteraemia from 2009/10 to 2011/12.

Dr Achyut Guleri, Consultant Microbiologist and Head of Department for Clinical Laboratory Medicine at Blackpool Teaching Hospitals NHS Foundation Trust says: “The rapid PCR screening system enables timely reporting, aides the clinical decision making process and ensures that high standards of patient management are maintained. Reduced healthcare associated infections are associated with significant cost savings that can be re-invested in other areas of healthcare, transforming patient care in the Fylde coast”.

The trust has carefully considered the clinical benefits and economic advantages of the programme and extended it beyond the pilot. Since the introduction of rapid PCR screening, the number of positive MRSA and MSSA infections including bacteraemias at the hospital have continued to decline with associated reduction in the average length of stay.

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3M Takes Over UK Rapid Diagnostics Company Acolyte Biomedica

3M has acquired Acolyte Biomedica Ltd., a Salisbury, UK-based provider of an automated microbial detection platform that aids in the rapid detection, diagnosis, and treatment of infectious diseases.

Acolyte Biomedica Ltd.  develops, manufactures and markets rapid microbiology products and has an exclusive global license to AK Rapid technology, granted from DSTL for clinical and veterinary use. It has further developed this ultra sensitive detection technology into a series of commercial prototype products, which rapidly detect the presence of bacteria and determine their antibiotic susceptibility direct from clinical samples such as blood.

In January 2006, Acolyte launched a rapid culture-based MRSA test, BacLite Rapid, which can detect the presence or absence of MRSA direct from clinical samples in less than five hours. This is the only available rapid screening test which can discriminate between live and dead bacteria allowing clinicians to determine the risk of resistant bacteria spreading in the hospital environment.

Acolyte Biomedica brings to 3M’s infection prevention platform a pipeline of rapid culture-based screening tests for microbes, such as MRSA and vancomycin-resistant enterococcus (VRE), that simplify the diagnostic process by automating traditional culture methodology resulting in reliable confirmed ‘negatives’ in hours rather than days.

Early detection of dangerous microbes is becoming more important as multiple resistant bacteria strains become more prevalent. Acolyte Biomedica helps hospitals control high-risk infections through improved screening and targeted treatment of methicillin-resistant Staphylococcus aureus (MRSA), a type of bacteria that is resistant to certain antibiotics and occurs most frequently in hospital patients who have weakened immune systems.

The addition of Acolyte Biomedica allows 3M to expand more quickly into the emerging market of infection prevention diagnostics, especially in Europe where Acolyte Biomedica has a commercialized product for MRSA. Now, 3M will be able to provide customers around the world with rapid, easy-to-use microbial diagnostics that help to reduce the impact of resistant microbes and improve hospital laboratory efficiency.

“This acquisition builds on 3M’s innovative research and development in the medical diagnostics area and is a natural extension of our core infection prevention business,” said Chuck Kummeth, division vice president, 3M Medical Division. “Our vision is to continue expanding our platform to include diagnostic solutions ranging from simple, culture-based approaches to more advanced molecular diagnostics that will help hospitals to improve the quality of patient care.”

3M’s infection prevention portfolio includes diagnostic testing, sterilization assurance, skin preparation, sterile field and surface, wound management and environmental cleaning.

Acolyte Biomedica Ltd. was formed in 2000 and is based at Porton Down, Salisbury, UK, where it employs 13 specialist scientists and commercial staff. It has been funded by shareholders Porton Capital, DSTL/Ploughshare Innovations, Partnerships UK and Angle Plc. 

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Pseudomonas aeruginosa Added to Microbiologics EZ-CFU Quantitative QC Microorganism Product Line for Growth Promotion Testing

Leading producer of ready-to-use quality control microorganisms, Microbiologics Inc., has added Pseudomonas aeruginosa ATCC® 9027™ to their popular EZ-CFU™ product line. EZ-CFU™ is designed for performing Growth Promotion Tests of microbiological culture media as described in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP). Pseudomonas aeruginosa ATCC® 9027™* is listed as one of the compendial challenge microorganisms for the Growth Promotion Test.

Chief Operating Officer of Microbiologics, Donna Scholer, comments, “We are very excited to have this Pseudomonas strain available in our EZ-CFU™ product line because it has been a popular customer request.” Scholer continues, “EZ-CFU™ is one of four distinct product lines Microbiologics manufactures for Growth Promotion Testing. With each product offering unique features and benefits, we are able to meet each customer’s individual needs in terms of test volume, preparation time, and ease-of-use.” Microbiologics, in business for more than 40 years, produces a broad range of ready-to-use quality control microorganism preparations. The company specializes in products for microbiological testing within industries such as clinical, medical device, pharmaceutical, cosmetic, food, and water. 

The purpose of the Growth Promotion Test is to determine the suitability of culture media that is used in pharmaceutical tests. The test is performed by inoculating the media with a small number of microorganisms (less than 100 colony forming units) to ensure the nutritive properties of the media are adequate to support even a small number of microorganisms. Pseudomonas aeruginosa is a fastidious microorganism that is notoriously difficult to grow. For this reason, it is an ideal strain to use for the Growth Promotion Test because it will meaningfully challenge the media. The EZ-CFU™ product line from Microbiologics is designed to deliver 10-100 colony forming units per 0.1 ml of hydrated suspension.

About Microbiologics:

Microbiologics manufactures cost‐effective, reliable, and easy-to-use microorganism preparations for Quality Control testing in microbiology laboratories across multiple disciplines including clinical, food, pharmaceutical and cosmetic, medical device, water and environmental. Microbiologics is an FDA registered establishment and has received ISO 9001 and ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. Currently, Microbiologics has an international distribution network of over 140 companies throughout the world.

For additional information, please contact Customer Service at (320) 253-7400, email marketing@microbiologics.com or visit www.microbiologics.com. 

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Two New bioMérieux Listeria Assays Now AOAC Approved

bioMérieux, a manufacturer in the field of in vitro diagnostics, today received two First Action Official Methods of Analysis (OMA) approvals from AOAC International for innovative food safety testing methods: VIDAS UP Listeria (LPT) and VIDAS Listeria monocytogenes xpress (LMX). The AOAC Expert Review Panel (ERP) approval of two food pathogen tests simultaneously highlights the reliability and significance of this complete Listeria screening solution, the company said.

VIDAS UP LPT and VIDAS LMX complement the company’s other next day food safety tests, VIDAS UP E. coli O157 (including H7) and VIDAS UP Salmonella, which are also based on phage technology.

The capability of both assays to test sample sizes of up to 125g, represents another industry milestone. These test approvals mirror the recent USDA-FSIS MLG 8.08 requirement to test larger composite sample sizes.

The new VIDAS UP LPT solution utilizes recombinant bacteriophage (phage) proteins that offer best-in-class specificity and sensitivity for the targeted and rapid detection of Listeria species in food and environmental samples. The VIDAS UP LPT assay is one of the most rapid and easy-touse Listeria spp. screening tests for food and environmental samples. Based on phage protein technology, it is able to detect low contamination levels and provides an extremely simple enrichment protocol, which reduces laboratory hands-on time, and delivers results in 27 hours as compared to reference methods, which require up to five days.

The VIDAS LMX assay is one of the most rapid, automated, easy-to-use solutions for the screening of L. monocytogenes, the human pathogenic, adulterant strain of Listeria, in food and environmental samples. VIDAS LMX delivers results in as little as 28 hours, where traditional methods can take up to three days. The test provides a simple sample preparation, with minimal manipulations, resulting in an optimized laboratory workflow.

VIDAS UP LPT & LMX have already been ISO 16140 certified by AFNOR for all human foods and production environment samples.

These two Official Methods of Analysis (OMA) approvals from AOAC INTERNATIONAL total close to 20 OMAs bioMérieux has obtained for its quality solutions.

"The 2011 listeria cantaloupe outbreak killed 33 people and was the third largest food outbreak in the US. bioMérieux is committed to bringing innovative solutions to our customers to ensure a safer food supply.” declared Nicolas Cartier, Corporate Vice-President, Industrial Microbiology Unit of bioMérieux. “VIDAS UP LPT is the newest member of the VIDAS UP menu that simplifies agrifood laboratories’ workflow, enabling improved cost-efficiency of food production."

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UC Davis Developing Rapid Pathogen Tests for Food Safety

Advances in pathogen testing are coming soon, according to Trevor Suslow, extension research specialist for preharvest to post-harvest produce safety at the University of California-Davis.

“We’re trying to develop a rapid system or index for assessing the likelihood that pathogens will be present,” Suslow said.
In fact, Suslow says several systems are in development.

“Everyone’s searching for a validated approach for predicting food safety,” he said.

In particular, listeria is at the forefront of many industry discussions.
“We get a lot of questions of listeria contaminations, and what it takes to be compliant with the increasing expectations of retailers and buyers,” Suslow said.

United Fresh is taking the lead in pulling together a white paper that will be released shortly, according to Suslow. The goal is to present a sort of how-to manual for the industry, in which best practices for prevention and environmental monitoring of listeria are detailed.

New testing systems

These systems focus on delivering answers faster.
“You have to have an answer on if pathogens are present before you ship, so the latest advancements are in the sensitivity of the detection,” Suslow said.

“These new testing systems focus on placing the samples in an enrichment culture to help encourage those pathogens to multiply and increase in number so they can be more easily detected,” he said. “You are basically just growing enough of what may be present so you can more easily detect it.”

Then, there are several techniques to sort out any potential pathogens.
“There are a number of creative and sophisticated systems, either using magnetic or specially formulated viruses that will attach to something like E. coli or salmonella,” Suslow explained.

These processes will help to reduce the amount of time needed for labs to come to a conclusion on whether the sample needs to be rejected or accepted.

In some cases, traditional tests may have taken somewhere between three and four days, whereas these new rapid systems can have results in 12-24 hours.

Suslow said there are other various lab techniques and specifics that can affect the specific time each test takes to finish.

For example, listeria, which grows slower, needs to be grown for 20-24 hours to prevent what Suslow calls a false negative, while E. coli or even salmonella can be detected in about 12 hours.

Still, the improvements are noticeable.

“If you are going to be testing, there are much better platforms out there now than there have been for the last couple of years,” he said.

Of course, Suslow doesn’t want everyone to immediately start testing using this new system in hopes of avoiding an outbreak situation.

For one thing, it can be costly and time consuming for growers to do this, despite that the more tests that are done, the more cost effective each one becomes.

Prevention’s best

Instead, Suslow said he thinks contamination is really best if it’s simply prevented in the first place.

“Testing for pathogens won’t give you any better results than if you just have a well-managed, audited food safety system in place,” he said.
In cases where an issue or a specific case does arise, that’s when Suslow said pathogen testing is most effective.

“If a situation comes up, and you want to try and assure it doesn’t represent an actual contamination, that’s where I’d recommend you spend the target dollars to pathogen test,” he said.

He also said the industry needs to continue to work on evaluating environmental testing in packing facilities, which already is becoming more widespread at fresh processing locations.

Source: The Grower

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