Global Leaders in Food Safety Testing

 

Food and Beverage News

Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, today announced the successful addition of Biomedal’s Food Safety division to its portfolio. Biomedal Food Safety, acquired from Seville, Spain-based Biomedal, offers a wide range of allergen tests including the GlutenTox® product line which contains the highly specific G12 antibody which specifically detects the most immunogenic component that is responsible for gluten intolerance. GlutenTox® Pro holds the certification of the AOAC Research Institute for Performance Tested methods (certificate no. 061502).

The new division will continue to be based in Seville, and be named Hygiena Diagnóstica España S.L. It will provide more than 20 specific allergen tests available as a sensitive enzyme linked immunosorbent assay (ELISA) format or a simple dipstick format that can be easily used to verify cleaning efforts and test finished products.

“We are excited to welcome the new team to Hygiena and look forward to serving our global food and beverage customers with a wider food safety testing portfolio,” said Steven Nason, Chief Executive Officer of Hygiena “Our allergen business has been growing rapidly and customers around the world have been asking us for a wider array of allergen tests. With this acquisition of Biomedal Food Safety, we now offer an allergen line that is best in class. We will continue investing in new product research and development and further expand our allergen product portfolio.”

Biomedal Food Safety employees will become employees of Hygiena, and the division’s products will continue to be available through its existing distribution network.
The Biomedal Food Safety division is a leading provider of allergen tests to top food processors and its sales growth has averaged 25% over the last 5 years.

Hygiena’s BAX® System – a genetics-based screening method – has been re-adopted by the USDA’s Food Safety and Inspection Service (FSIS) to detect harmful pathogens in meat, poultry, and eggs.

On July 6, USDA FSIS awarded Hygiena an indefinite delivery/indefinite quantity contract for pathogen detection instruments and kits for a base of one year, with an option for the agency to continue the contract for up to five years. The BAX® System for pathogen detection has been the agency’s preferred method for detecting harmful pathogens in the nation’s meat, poultry, and egg supply for more than 10 years.

“We are extremely pleased that the BAX® System has once again been evaluated by the FSIS and found to meet the agency’s standards for performance” said Shannon Bullard, Global Product Manager for Hygiena. “The BAX® System was the first to offer molecular-based pathogen tests to the food industry, and our commitment to continuous improvement is still providing the best science-based solutions for evolving food protection needs. This award is a testament to the long relationship Hygiena has shared with the USDA and the performance of this valuable platform.”

Food processing companies around the world rely on the BAX® System to detect pathogens or other organisms in raw ingredients, finished products and environmental samples. The automated system uses leading-edge technology, including polymerase chain reaction (PCR) assays, tableted reagents and optimized media to detect Salmonella, Listeria species, Listeria monocytogenes, E. coli O157:H7 and STEC, Campylobacter, Staphylococcus aureus, Vibrio, and yeast and mold. Many of these tests have been certified by AOAC and AFNOR and/or approved by government agencies in the Americas, Asia and Europe. For more information about the BAX® System, please visit www.hygiena.com.

AFNOR, an ISO certification body in France that is a widely recognized European accreditation body of food safety detection methods, has now issued extensions in accordance with the new ISO standard 16140-2 for all 10 BAX® System assays previously certified.

In addition to extending all the assays to the newest ISO standard and software version, the BAX® System Real-Time PCR assay for Salmonella was also extended for dairy (except powdered milk) and chocolate food categories and a shortened enrichment protocol for raw meats and raw seafood. With these additions, the BAX® System Real-Time PCR assay for Salmonella is now certified for all human food products, pet food and environmental samples (except primary production samples). The 10 assays (real-time and traditional PCR) are listed below:

BAX System Real-Time and traditional assays meeting ISO 16140-2 and AFNOR:

BAX® System Real-Time PCR Assay for Salmonella

BAX® System X5 PCR Assay for Listeria monocytogenes

BAX® System Real-Time PCR Assay for E. coli O157:H7

BAX® System PCR Assay for E. coli O157:H7 MP

BAX® System PCR assay for Salmonella/ Salmonella 2

BAX® System X5 PCR Assay for E. coli O157:H7

BAX® System X5 PCR Assay for Salmonella 

BAX® System PCR Assay for Genus Listeria 24E

BAX® System PCR Assay for Listeria monocytogenes 24E

BAX® System X5 PCR Assay for Genus Listeria

“These certifications from AFNOR, which is recognized internationally, emphasizes the ability of our PCR assays to detect potentially pathogenic bacteria in food and environmental samples with performance equal to or better than the ISO reference method,” said Ed Luterbach, Chief Commercialization Officer at Hygiena. “We believe we are one of the very few companies that has all of its PCR assays AFNOR-validated. These certifications are backed up by independent studies that have demonstrated the effectiveness of the BAX® System in a variety of facilities and situations.”

ABOUT ISO 16140-2

The International Organization for Standardization (ISO) standard 16140-2 specifies a technical protocol to validate alternative methods of microbiology to reference methods for testing in the food chain. It is used to validate methods to analysis of microorganisms (bacteria and fungi in particular) for food, animal feed, environmental samples, and primary production sample. 

Actero™ Elite Enrichment Media for the BAX® System reduces sample handling, improves throughput and time to results

Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, announced that it has begun selling Actero™ Elite Enrichment Media, validated for use with the BAX® System real-time PCR assays for Listeria and Salmonella.
The two Actero™ Elite Enrichment Media formulations, produced by FoodChek Systems, Inc., are known in the industry for superior quality, single-step enrichment allowing for reduced sample handling, reduced enrichment media volumes, and faster time to results.
“We are delighted to be able to provide Actero™ Elite Enrichment Media to our BAX® System customers, which enables them to improve their ability to detect pathogens in food or environmental samples,” said Shannon Bullard, global product manager at Hygiena. “This partnership provides customers with industry leading technology providing accurate and efficient pathogen detection that is easy to use resulting in faster product release.”
William Hogan, FoodChek President & CEO, said, “We are very pleased with the opportunity of working with Hygiena and its outstanding food safety testing expertise. Hygiene’s competencies, reputation of food safety excellence and global reach make them an ideal partner for FoodChek in bringing our Actero Elite Enrichment Media to the food safety testing market.”
The Actero™ Elite Enrichment Media is formulated to suppress the growth of non-target organisms while promoting the growth of target organisms. Together, Actero™ Elite Enrichment Media and the BAX® System can provide environmental detection results in 22 hours for Listeria and 16 hours for Salmonella. The products are available in powder and liquid MediaBox™ formats. Other benefits of each media formulation are:
• For Listeria species assays, time to results can occur between 18-26 hours depending on sample source, and they feature a single-step enrichment.
• For Salmonella species assays, time to results can occur between 14-26 hours depending on sample source, and they feature a single-step enrichment.
Hygiena’s BAX® System PCR Assays have been certified as a Performance Tested Method by the AOAC Research Institute (AOAC-RI), and are also approved by Health Canada, the country’s national health agency, for use in food and environmental surface samples.

ABOUT FOODCHEK
The FoodChek Systems Inc. mission is to be the leading global developer and provider of proprietary rapid and accurate food safety tests for the detection of foodborne and environmental pathogens and other microorganisms throughout the human and pet food production chains. The company's expertise is in the development and commercialization of proprietary rapid, accurate and cost-effective food safety tests focused on the detection of Listeria spp., Listeria monocytogenes, and Salmonella spp. under the Actero™ Elite Enrichment Media brand of products. FoodChek is headquartered in Calgary, Alberta, Canada.

 

Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, announced that it has opened a new facility serving customers in Canada. The new division is now known as Hygiena Canada Ltd.
The establishment of Hygiena Canada creates a permanent presence in the region for Hygiena, as the company continues to grow and provide key hygiene monitoring and molecular diagnostic testing and equipment to customers in food safety, healthcare, and other fields as the need for hygiene and safety testing expands globally.
“We are excited about working with our Canadian customers and distributors through Hygiena Canada. Having a facility in Canada will allow us to better address growing opportunities there,” said Steven Nason, CEO of Hygiena. “This new facility is part of Hygiena’s overall strategy to increase access, service and support of its products worldwide.”
Hygiena Canada is a fully owned subsidiary of Hygiena. The Mississauga Ontario, facility will be the first to warehouse all Hygiena products, including the EnSure and SystemSure PLUS ATP Sanitation Monitoring Systems, allergen and indicator organism tests and the BAX® System PCR assays and RiboPrinter® DNA fingerprinting system. Sales, marketing, customer service, operations and warehousing will all function in the new facility.
Hygiena BAX® System validated PCR Assays have been approved by Health Canada, the country’s national health agency, for use in foods and environmental surface samples
The federal agency has included the BAX® System methodologies in its Compendium of Analytical Methods. The Compendium is the official Canadian method reference approved and used by Health Canada’s Health Products and Food Branch to determine compliance with government standards and guidelines.

AOAC Certifies BAX® System Real-Time PCR Assays for Non-O157:H7 STEC in 25g Flour and Ground Beef

(7 February 2018) -- Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, today announced it received extensions to its AOAC-Research Institute validation for the BAX® System Real-Time PCR Assay Suite for STEC for two additional matrices: 25g flour and 25g ground beef. AOAC-RI validated the assay as equivalent to the reference culture method for detecting shiga toxin-producing E. coli (STEC), but with faster time to results.

 

“We are delighted and proud to receive certification from AOAC for these two matrices, which demonstrate to producers and regulators that Hygiena’s BAX® System is an approved method by a recognized accreditation body,” said Dr. Martin Easter, chief scientific officer of Hygiena. “These methods are important tools to help reduce the occurrence of recent and serious outbreaks in these products.”
The flour validation was executed to help US and Canadian producers avoid contamination issues that have persisted in flour, cake and pancake mixes and raw dough since 2009. The 25g ground beef validation was completed to support European beef producers needing an accredited method for detection of STEC. These producers now can use the BAX® System with confidence that results are accurate and are certified as reliable and reproducible.
Hygiena’s BAX® System Real-Time PCR Assay Suite for STEC validation in 25g ground beef samples was shown to provide reliable and accurate results within a workday, supplying necessary information on pathogen presence. The real-time PCR assay could also accurately, and relatively rapidly, detect STEC in flour samples that, because of their dryness, have defied efforts to detect the bacteria.

 

About BAX® System
Food processing companies around the world rely on Hygiena’s BAX® System to detect pathogens or other organisms in raw ingredients, finished products and environmental samples. The automated system uses PCR technology to detect Salmonella, Listeria species, Listeria monocytogenes, E.coli O157:H7 and STEC, Campylobacter, Staphylococcus aureus, Vibrio, Cronobacter, Shigella, and yeast and mold. Many of these tests have been certified by AOAC and AFNOR and/or approved by government agencies globally. For more information about the BAX® System please visit www.hygiena.com.  

 

About AOAC
The AOAC Research Institute was incorporated in 1991 as a wholly owned subsidiary of AOAC INTERNATIONAL. The RI serves as an independent, third-party, nongovernment administrator of AOAC conformity assessment programs including the AOAC Performance Tested MethodsSM (PTM) and Official Methods of AnalysisSM (OMA) programs for alternative and sole source methods. The AOAC Performance Tested MethodsSM (PTM) program began in 1992 and has evolved into a premier method certification program for proprietary methods. Methods certified as Performance TestedSM were found to perform according to the manufacturer’s documented claims and are used throughout the global market place and within the regulatory arena.

AOAC Certifies BAX® System Real-Time PCR Assays for Non-O157:H7 STEC in 25g Flour and Ground Beef

(7 February 2018) -- Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, today announced it received extensions to its AOAC-Research Institute validation for the BAX® System Real-Time PCR Assay Suite for STEC for two additional matrices: 25g flour and 25g ground beef. AOAC-RI validated the assay as equivalent to the reference culture method for detecting shiga toxin-producing E. coli (STEC), but with faster time to results.

 

“We are delighted and proud to receive certification from AOAC for these two matrices, which demonstrate to producers and regulators that Hygiena’s BAX® System is an approved method by a recognized accreditation body,” said Dr. Martin Easter, chief scientific officer of Hygiena. “These methods are important tools to help reduce the occurrence of recent and serious outbreaks in these products.”
The flour validation was executed to help US and Canadian producers avoid contamination issues that have persisted in flour, cake and pancake mixes and raw dough since 2009. The 25g ground beef validation was completed to support European beef producers needing an accredited method for detection of STEC. These producers now can use the BAX® System with confidence that results are accurate and are certified as reliable and reproducible.
Hygiena’s BAX® System Real-Time PCR Assay Suite for STEC validation in 25g ground beef samples was shown to provide reliable and accurate results within a workday, supplying necessary information on pathogen presence. The real-time PCR assay could also accurately, and relatively rapidly, detect STEC in flour samples that, because of their dryness, have defied efforts to detect the bacteria.

 

About BAX® System
Food processing companies around the world rely on Hygiena’s BAX® System to detect pathogens or other organisms in raw ingredients, finished products and environmental samples. The automated system uses PCR technology to detect Salmonella, Listeria species, Listeria monocytogenes, E.coli O157:H7 and STEC, Campylobacter, Staphylococcus aureus, Vibrio, Cronobacter, Shigella, and yeast and mold. Many of these tests have been certified by AOAC and AFNOR and/or approved by government agencies globally. For more information about the BAX® System please visit www.hygiena.com.  

 

About AOAC
The AOAC Research Institute was incorporated in 1991 as a wholly owned subsidiary of AOAC INTERNATIONAL. The RI serves as an independent, third-party, nongovernment administrator of AOAC conformity assessment programs including the AOAC Performance Tested MethodsSM (PTM) and Official Methods of AnalysisSM (OMA) programs for alternative and sole source methods. The AOAC Performance Tested MethodsSM (PTM) program began in 1992 and has evolved into a premier method certification program for proprietary methods. Methods certified as Performance TestedSM were found to perform according to the manufacturer’s documented claims and are used throughout the global market place and within the regulatory arena.

NBC "Today" Show Brings Hygiena to the Gym

(18 January 2018) --Your gym workout may expose you to unwanted bacteria, according to a recent story on the NBC “Today” Show. The morning program used Hygiena’s SystemSURE Plus Cleaning Verification System and UltraSnap™ Surface ATP Tests to measure cleanliness levels on popular gym equipment, including weights, mats, and treadmills. To learn the results and see how you can protect yourself, watch the video.

Click the here to watch the video

Joint USDA/FDA study using BAX® System microbe identification points to sources of grocery Listeria contamination

Pathogens can lurk at any point in grocer supply chain, long-term research finds

 

(31 August 2017) -- A three-year multistate Listeria bacteria contamination study conducted by the USDA, FDA and academic scientists found that pathogenic and benign forms of the bacteria can lurk in common groceries, and can occur at any point from delivery to final consumer purchase. Listeria monocytogenes is particularly challenging to food safety systems because it can survive at refrigeration temperatures.  Because ready to eat foods can easily transmit L. monocytogenes, the USDA and FDA conducted the major study to look at the prevalence of the pathogen in grocery stores and ready-to-eat facilities in stores and delis.

While the incident numbers in this study appear low, the results are significant because L. monocytogenes is a leading cause of death from foodborne illness, especially among vulnerable consumers such as children, the elderly, and the immunocompromised.

The USDA/FDA “Market Basket Survey,” conducted from 2010 to 2013 at groceries in California, Maryland, Connecticut and Georgia, used the Hygiena BAX® system, which utilizes polymerase chain reaction (PCR) technology to quickly and accurately detect microbes.

“We are pleased that this significant and comprehensive market basket survey selected the Hygiena BAX® Q7 system to accurately detect possible pathogens in groceries,” said Kyle Rhoden, BAX® system product manager at Hygiena. “We are proud to have pioneered the application of PCR technology to food safety many years ago and for our partnerships with government agencies and food companies in ensuring a safe food supply.”

The study found that of 27,389 samples from 16 food categories, the proportion containing the pathogen Listeria monocytogenes ranged from zero in soft-ripened and semisoft cheese to 1.07 percent for raw cut vegetables. For Listeria-like organisms (which may or may not be pathogenic), proportions of positive samples ranged from 0.79 percent for the same cheeses to 4.76 percent for fresh crab meat or sushi.

The study also found that L. monocytogenes contamination did not vary according to packaging location (either by manufacturer plant or at the grocery itself), or by the type of store (national versus local grocery brand), suggesting that contamination is possible at any point in processing, storing and selling food.

The survey did reveal some good news—samples of delicatessen meats, seafood, cheese, and salads showed a significantly lower rate of contamination incidence than the same study conducted by the same group 10 years ago.

The USDA has adopted the Hygiena BAX® system into the USDA’s Microbiology Laboratory Guidebook (MLG), a reference for microbiology methodologies used to protect the nation’s food supply, marking another level of acceptance of the BAX® System by the food safety industry. The system has been adopted by the agency for detecting L. monocytogenes, Campylobacter, Salmonella, Escherichia coli O157:H7, and non-O157 Shiga Toxin-Producing Escherichia coli (STEC).

The BAX® System is a breakthrough genetics-based screening method that detects target bacteria in raw ingredients, finished food products and environmental samples. The automated, easy-to-use system has been available since 2000, when the BAX® System revolutionized rapid food pathogen testing.  More than 20 years later, the trusted, tried and true technology of the BAX® System continues to be in use by governments, food companies and laboratories around the world.

The study, “Survey for Listeria monocytogenes in and on ready-to-eat foods from retail establishments in the United States (2010 through 2013): assessing potential changes of pathogen prevalence and levels in a decade” was published in the Journal of Food Protection (Volume 80, No. 6, pages 903-921).