That said, here are my observations from this year’s Food Safety Summit:

I was struck by the large number of exhibitors from service and/or contract lab-related companies. Clearly there is a sizable and growing need in the food industry for “outside” help in meeting the food safety expectations for today’s food.

bioMerieux’s Vidas UP Salmonella test is good. It’s easy to use, provides excellent sensitivity/specificity, is fast and isn’t as expensive as comparable molecular methods. What’s not to like?

I spoke recently with Stan Bailey, Director of Scientific Affairs for bioMerieux Industry. Stan indicated that things have gone well since the product launch in June 2011, with the Vidas UP Salmonella exceeding even its high prelaunch expectations.

First a little about the test: bioMerieux uses phage technology for target capture. Given the unique specificity capability of phage, the VIDAS UP Salmonella’s performance is excellent. In addition, bioMerieux enhances the enrichment buffer with a supplement that eliminates the need for secondary enrichment. Following enrichment, there is a single transfer step prior to detection.

This combination of technology and design yields several benefits. With only one enrichment and one transfer step, VIDAS UP Salmonella is very easy to run and can provide final results in around 20 hours, depending on food matrix. In addition, the test has AOAC approval on a range of food matrixes. Just this week, AOAC announced that this approval has been extended to 375 g samples on certain key food matrixes.

There were 46.2 million pathogen tests performed in the US in 2010, and Salmonella was the leading pathogen tested. Clearly Salmonella is an important market niche.

This test can be run on existing Vidas systems in the industrial market, an installed base that SCI estimates to be more than 2,500 systems. Swapping out other versions of Vidas Salmonella assays certainly represents a good revenue base to start, but Stan indicated that 60-70% of revenues for the new assay represent new business for bioMerieux. That certainly speaks to the advantages of this assay over its competition. Stan went on to indicate that some of the new business is FSMA generated since preparation for that regulation is driving testing.

When researching Food Micro—5, SCI found that there were 46.2 million pathogen tests performed in the US in 2010, and that Salmonella was the leading pathogen tested. Clearly Salmonella is an important market niche. It’s no surprise then, that there 10+ molecular methods along with several antibody-based methods currently available. How will the Vidas UP Salmonella stack up against these companies/methods? For example, will the automation and total cost of ownership of the Roka Atlas be too compelling to large volume test locations? Will the new molecular methods from 3M and/or Neogen be better solutions for small to mid-sized organizations?

It is worth mentioning that there is some talk of bioMerieux coming out with a molecular pathogen test method. Which begs the question, why, if this product is doing so well? Are the food companies and contract testing labs continuing to move away from non-molecular test methods and insisting on molecular methods instead? That’s what the data in Food Micro—5 indicates.

If bioMerieux does come out with a molecular method, what approach will they use? They appear to have at least three or four options available. And if they do produce a molecular method, what will it mean to the Vidas UP Salmonella test?

Find more more information on the Vidas UP Salmonella here.

I recently spoke with Ted Moskal, president and CSO of Vivione Biosciences, LLC, which has reintroduced the flow cytometry-based pathogen detection method called Rapid-B. Its key advantage over other pathogen detection approaches is rapid results. Their detection technology enables shorter enrichment times, which enables quicker release of end products as depicted in this comparison table below taken from the company website.

The company (called Litmus Rapid-B at the time) launched the method about five years ago and created some solid interest. However, market acceptance was delayed as the company spent much of the next few years on method development and the generation of third-party data for real world applications.

At the heart of the interest in the Rapid-B technology are rapid results. Getting pathogen results as quickly as possible is important for certain applications and customers.

In Food Micro—5, SCI’s recent report on food microbiology testing in the U.S. food industry, we document that there were just over 46 million pathogen tests conducted in the U.S. in 2010. Not all of these tests require pathogen results ASAP, but in some cases inventory is being held or risks need to be minimized. For these applications there is a gap between current detection methods and their business/risk management requirements.

The Rapid-B approach utilizes antibodies that tag the target and then get detected in the flow cytometer detection cell. Currently they have tests for Salmonella, E. coli O157, Vibrio, and Staph, all requiring reduced enrichment times when combined with the system’s low limit-of-detection. Environmental pathogen samples seem to be an excellent application for the technology.

A paper was recently published on the technology entitled, “Reduction of food matrix interference by a combination of sample preparation and multi-dimensional gating techniques to facilitate rapid, high sensi-tivity analysis for Escherichia coli serotype O157 by flow cytometry.” Researched and published by an independent third-party, the paper is available here.

As discussed in this paper, key applications for the Rapid-B system are meat and possibly, produce water. If a food plant is holding significant inventory or wants tight control of the production environment, they might find this a worthwhile product to consider. Because Rapid-B can distinguish live versus dead cells, the system might also be used for process control and/or biomapping of a food production facility. The instrument pricing is just over $100,000 while the test cost is about $15.

There’s a good article by Julian Turner on Food Processing-Technology.com that speaks to some of these new advances.

Turner begins by referring to some of our market statistics, and then quotes my friend and former colleague, Crispin Philpott, now at Roka:

“The global food safety diagnostics market continues annual expansion in double-digit figures,” confirmed Crispin Philpott, strategic account manager at Roka Bioscience and a leading authority in food safety technology.

“It draws the increasing attention of both the investment community and method developers currently outside the space.”

Turner continues:

“This injection of public and private capital is more than matched by intellectual investment on the part of regulators, industry and academia. In short, the brightest and the best in the food safety industry have come together in response to a series of high-profile food contamination cases on both sides of the Atlantic.”

The article highlights some of the new technology coming out of all the continued focus and activity. You can read the full article here.

This injection of public and private capital is more than matched by intellectual investment on the part of regulators, industry and academia. In short, the brightest and the best in the food safety industry have come together in response to a series of high-profile food contamination cases on both sides of the Atlantic.

In my last blog, I discussed Life Technologies’ acquisition of Matrix MicroScience. A new collaboration between SDIX and BD Diagnostics, a segment of BD (Becton, Dickinson and Company), also is intriguing.

BD has been relatively quiet in the food space over the past decade. Many people rely on BD media for food microbiology analysis, but BD hasn’t really built on this foundation.

SDIX continues to expand and build upon its easy to use lateral flow devices (LFD). Also, the company has developed some clever and effective enrichment medias that when combined with the LFDs make the overall detection that much stronger and better.

Now these two companies are partnering to enable BD to offer new detection capabilities. SDIX will provide the antibodies and phage technology while BD will develop the detection system and market the product.

What niche is BD targeting and why are they utilizing an antibody-based approach? In 2009, BD acquired HandyLab and its molecular technology for $275M. While principally targeted to enhancing their competitive position in HAI (healthcare associated infections), the HandyLabs box also could offer a competitive advantage in food microbiology given its automation and ease of use (EOU).

The U.S. food market seems to increasingly be using molecular methods, and BD has an excellent molecular solution. So why is BD now investing in an antibody-based approach?

The question that comes to mind for me is how this new BD/SDIX product—which is probably one to two years away from commercialization—might be better than new product announcements from Roka, 3M, and most recently Neogen’s ANSR?

BD better have some good market success for this new detection platform. The upfront payment of $1.25M alone, combined with up to $2.5M in performance payouts and royalties, means BD will have to sell 250,000 tests just to cover this upfront signing fee (based on the assumption that the test selling price would be $8, and the margin would be in the 60-65% range). This doesn’t include R&D, sales, marketing, and support expenses associated with this project.

Strategic Consulting has just completed a market research and publication cycle for its most recent report, Food Micro, Sixth Edition: Food Microbiology Testing in Europe. One thing is clear, the food microbiology market will see more and more partnering of companies, products and technologies to come up with solutions that meet customer requirements. It’s not always possible to get to that “best solution” based on the technologies resident at one company. Why not go out and combine strengths with others if it will result in a better solution?

A couple of new diagnostic company pairings have created synergies with the potential to deliver real innovation in food safety testing: Life Technologies’ acquisition in January of Matrix MicroScience, and a new collaboration announced in February between SDIX and BD Diagnostics, a segment of BD (Becton, Dickinson and Company).

Life Technologies Acquires Matrix MicroScience

Matrix MicroScience first introduced its unique, patented sample concentration/cleanup technology over five years ago. It immediately captured the food industry’s imagination and interest because of its potential to both reduce enrichment time and help clean up the sample to enable better analysis. Because there is only so much that detection technologies can do to improve test performance, the logical progression is to enhance the sample prep phase of the analysis. Matrix clearly leads in this effort.

After a couple of product design improvements, it seems Matrix is now ready to offer a viable solution that the market will embrace.

In the meantime, Life Technologies seems to have gained some market traction over the past year or so. Their range of approved assays has increased, as has interest in their open platform instrument. However, Life is in a tough battle with other more entrenched competitors, and the market now has more than a dozen molecular platforms to choose from along with several antibody-based options.

The new STEC detection requirements are well suited to an antibody capture approach before the detection step. This approach is at the heart of BioControl’s GDS, which has significant share of the existing O157 market. Using Matrix’s technology as the front end could shorten the enrichment time as well as capture all of the possible O-types in the sample for subsequent virulence detection by Life’s molecular technology.

To date, detection companies have been hesitant to seek approvals for an approach that combines the Matrix front end with their detection method. With this acquisition, Life Technologies will certainly do so, and be able to demonstrate good sensitivity/specificity combined with reduced time-to-results.

Details of Matrix’s purchase price have not been made public so it’s difficult to comment on the performance expectations required to make this a profitable transaction.

As has been the case over the past number of years, the number of players in the food microbiology diagnostics market is shrinking. This acquisition is another example of a single-product company (Matrix) joining with a company with strong channel access (Life).

Up next, a look at the BD Diagnostics/SDIX collaboration.

Woodstock, VT February 9, 2012 — Europe is a substantial market for food microbiology testing. With a population of over 500 million, the 27 countries of the European Union (EU) conducted an estimated 275 million food safety microbiology tests in 2011, according to Food Micro, Sixth Edition: Food Microbiology Testing in Europe (Food Micro—6), a new market report from Strategic Consulting, Inc. In comparison, there were 213 million such tests conducted in the US in 2010.

EU Food Safety Test Volume 2005 - 2011

Food Micro—6 is the first definitive report to focus exclusively on the European food microbiology testing market, and reviews the methods, technologies, companies, regulations and trends shaping food safety testing in Europe.

According to Tom Weschler, president of Strategic Consulting and lead author of Food Micro-6, “Food safety microbiology testing in the EU will approach 350 million total tests in 2016, at which point the market should top $1 billion in value.” Given these numbers and other factors, the European food safety testing market must be examined and understood, Weschler says. “A resurgence in public awareness in the wake of the 2011 E. coli outbreak in Germany, and the continued focus of the European Food Safety Authority on EU-wide systems, could drive test volumes even higher.”

A resurgence in public awareness in the wake of the 2011 E. coli outbreak in Germany, and the continued focus of the European Food Safety Authority on EU-wide systems, could drive test volumes even higher.

In preparing this new and comprehensive review of the European food microbiology testing market, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries accounting for 77% of all agricultural/food value-added in the European Union. Because of this primary research with food-processing plants throughout Europe, Food Micro—6 is able to offer new, detailed data on European food safety testing such as test volumes, methods used for routine and pathogen testing, and costs per test performed. Differences in testing practices are analyzed for the meat, dairy, fruits/vegetables, and processed food segments. Variations within countries are outlined, and expected changes in future testing practices are discussed.

“Routine” microbiology tests used in the food processing industry in Europe to indicate the presence of microorganisms in the plant or food product include total bacteria, E. coli, Staphylococcus, yeast and molds. In 2011, these routine tests numbered 225.4 million. The balance of food microbiology tests in Europe were 49.9 million “pathogen” tests, which look for specific microbes such as Salmonella, Listeria, L. mono, Campylobacter, and E. coli O157.

Food Micro—6 also profiles the leading diagnostic companies competing in the food safety testing market including a discussion of new technologies and market strategies. Food Micro—6 includes company profiles for Becton-Dickinson, BioControl, bioMérieux, Bio-Rad, BIOTECON, DuPont Qualicon, Foss A/S, Idaho Technology, Life Technologies (ABI), Merck Millipore, 3M, Neogen, Pall Corporation, QIAGEN, Roka Bioscience, R-Biopharm, SDIX and Thermo Fisher.

Food Micro—6 is a companion report to Food Micro, Fifth Edition: Microbiology Testing in the U.S. Food Industry (Food Micro—5), published by SCI in 2011, which reviews the current practices and changes impacting food safety testing at 9,350 U.S. food processing plants.

Strategic Consulting has published six reports to date reviewing quality and safety testing in the food industry. The food sector represents almost 50% of the total industrial microbiology testing market, and is more than double the size of any other industrial segment including pharmaceutical, personal care products, beverage, environmental, and industrial processes. SCI market research reports are widely accepted by leading diagnostic manufacturers and investors as highly credible analyses of the industry.

For more information about Food Micro, Sixth Edition: Food Microbiology Testing in Europe, call Strategic Consulting’s U.S. office at 802-457-9933.

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Strategic Consulting, Inc. (SCI) provides market reports and business consulting for industrial diagnostics companies delivering microbiology-based products for quality and safety testing in food, beverages, pharmaceuticals, personal care products, environmental water, and industrial-process water. With more than 75 combined years of international management in the industrial marketplace, SCI’s principals have proven success in working with venture capital backed start-ups, publicly traded companies, technology acquisitions, and transformation of underachieving companies. For more information on Strategic Consulting, Inc. and its current market reports, visit www.strategic-consult.com or call 802-457-9933. Follow SCI president and industry expert, Tom Weschler, on LinkedIn or Twitter @tomweschler.

Food Micro—6 is the first definitive report to focus exclusively on the European food microbiology testing market, and reviews the methods, technologies, companies, regulations and trends shaping food safety testing in Europe.

In preparing this new report, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries accounting for 77% of all agricultural/food value-added in the European Union. Because of this primary research with European food-processing plants, Food Micro—6 is able to offer new, detailed data on European food safety testing including:

• Test volumes
• Market value
• Methods used for routine and pathogen testing
• Costs per test performed
• Testing practices by segment for meat, dairy, fruits/vegetables, and processed food
• Variations by country
• Expected changes in future testing practices

Strategic Consulting has published six reports to date reviewing quality and safety testing in the food industry. The food sector represents almost 50% of the total industrial microbiology testing market, and is more than double the size of any other industrial segment including pharmaceutical, personal care products, beverage, environmental, and industrial processes.

For more information about Food Micro, Sixth Edition: Food Microbiology Testing in Europe, download a prospectus, email info@strategic-consult.com, or call Strategic Consulting’s U.S. office at 802-457-9933.

“Pathogen testing has now been made simple and affordable,” said Niki Montgomery, 3M Food Safety global marketing development manager. “…Numerous organisms can be tested in a single run and it was designed to help our customers perform fewer repeat tests and make critical decisions faster.”

Read the full press release.

After reviews of 3M’s investor presentations and IAFP meeting buzz, we mentioned rumors of this product/technology several months ago in this blog. Products like this will help food producers justify keeping pathogen analysis at their plant labs. Also, this technology platform should help companies migrate from traditional and other methods to molecular methods.

Woodstock, VT December 12, 2011 — Europe is a substantial market for food safety microbiology testing. The population of the 27 countries of the European Union is 500 million, nearly 60% greater than the US population. Altogether, EU countries performed an estimated 275 million food micro tests in 2011. In comparison, there were 213 million such tests conducted in the US in 2010.

Food Micro, Sixth Edition: Food Microbiology Testing in Europe from Strategic Consulting, Inc. (SCI) is the first definitive report focusing exclusively on the European food safety microbiology testing market. Food Micro—6 reviews the important markets, methods, technologies and trends shaping food safety testing in Europe.

In addition to size, the European food safety testing market differs from the US market in areas such as methods used, organisms tested, and current and pending regulations. As a result, says Thomas Weschler, president of SCI and lead author of Food Micro—6, “Europe must be examined and understood as a separate entity as it relates to food microbiology testing, and not simply thought of and treated as ‘like the US.’”

“Europe must be examined and understood as a separate entity as it relates to food microbiology testing, and not simply thought of and treated as ‘like the US.’”

A strong global link between the European and US food markets remains however, Weschler says. Key global food companies such as Nestle and Kraft have a significant presence in both geographies. European consumers, like their American counterparts, want access to all types of food year-round and as a result draw increasingly from a global food supply.

At the same time, there is a growing public awareness of food safety issues, with the recent E. coli outbreak in Germany only one of the incidents heightening concern about contaminants in the food supply. “Growing public concern about food safety could ramp up change in Europe, and increased regulations and testing volumes should follow suit,” Weschler says.

In preparing this new and comprehensive review of the European food microbiology testing market, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries representing more than 75% of all food production in the EU. Through this primary research at food-processing plants throughout Europe, Food Micro—6 offers new data on European food safety testing practices including overall test volume, cost per test, and methods used for routine and pathogen testing. Differences in testing practices within food segments and countries also are detailed, and expected changes in future testing practices are discussed.

Like all SCI publications, Food Micro—6 is based on new, primary research and industry-specific expertise and analysis. Food Micro—6 incorporates:

• Lengthy interviews with food processing plants in the meat, dairy, fruit/vegetable, and processed food segments in 11 European countries representing more than 75% of the total food production in the EU.

• A discussion of key drivers for food microbiology testing, and a country-by-country comparison of total testing, organisms tested, and methods used.

• Test volumes, methods, and products used for routine, environmental and pathogen tests for TVO, Coliform, Yeast/Mold, ATP, Staphylococcus, Salmonella, Listeria, L. mono, E. coli O157, and Campylobacter.

• Forecasts for the state of the market in 2016 including routine, pathogen and overall test volumes and market values.

• Insights from Strategic Consulting’s principals honed over more than 75 combined years in the worldwide industrial diagnostics marketplace.

Strategic Consulting’s long tenure in the industrial diagnostics industry includes the publication of 14 research reports addressing critical market topics over the last 15 years. Strategic Consulting market research reports are widely accepted by leading diagnostic manufacturers and investors as highly credible analyses of the industry.

Food Micro—6 will publish in January 2012 but orders placed before January 16, 2012 can receive a pre-publication savings of $500 off the report price.

For more information on Food Micro—6, request a prospectus, email info@strategic-consult.com, or call (802) 457-9933.

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Strategic Consulting, Inc. (SCI) provides market reports and business consulting for industrial diagnostics companies delivering microbiology-based products for quality and safety testing in food, beverages, pharmaceuticals, personal care products, environmental water, and industrial-process water. For more information on Strategic Consulting, Inc. and its current market reports, visit www.strategic-consult.com or call 802-457-9933. Follow SCI president and industry expert, Thomas R. Weschler, on LinkedIn or Twitter @tomweschler.