NEW YORK (GenomeWeb) – In a bid to expand its footprint in the food testing space, BioMérieux in November launched a molecular pathogen detection platform called GeneUp, which aims to tap into a part of the food industry market unreachable with the firm's widely adopted immunoassay-based platform.
With the new product, BioMérieux joins a dynamic and rapidly expanding market for molecular foodborne pathogen testing, with around 15 companies now offering systems to detect pathogen DNA. The launch also occurs on the backdrop of greater scrutiny of the food industry, increased funding to enforce the Food Safety Modernization Act (FSMA), and pricing pressure from the growth of third-party testing labs.
BioMérieux now offers both immunoassays and molecular assays for food microbiology testing, and there are advantages to each methodology, Stan Bailey, senior director of scientific affairs at BioMérieux told GenomeWeb in an interview.
Vidas, the company's automated fluorescent immunoassay-based platform, has been on the market for more than 20 years and is widely used by the half of the food testing market that prefers that type of testing, Bailey said.
But unlike many competitors in the space — such as DuPont, Bio-Rad, Qiagen, or 3M — BioMérieux did not previously have a molecular food testing offering.
"That left us with about half the market that we couldn't play in," Bailey said.
In addition, about a year ago BioMérieux purchased the European Centre for Expertise and Research on Microbial Agents, or CEERAM, which has developed "the only real commercial virus testing," Bailey said, so the firm needed a molecular platform to run those tests as well.
Bailey, who spent 35 years as a senior researcher for the US Department of Agriculture before joining BioMérieux about eight years ago, noted that industrial applications — primarily food and pharmaceutical testing — make up 20 percent of sales for the Marcy L'Etoile, France-based company. The clinical side, which includes the FilmArray platform from subsidiary BioFire and the Vitek mass spectrometry platform and blood culture products, for example, constitutes the remaining sales.
BioMérieux began developing GeneUp a few years ago in collaboration with BioFire, and then later acquired that company.
"[BioFire] had developed very original real-time PCR work for the department of defense and for others, so they came with many years of high-level molecular diagnostic development experience. We utilized them to develop the platform for us that we will be selling through our BioMérieux industry subsidiaries," explained Bailey.
The GeneUp system performs real-time PCR coupled with end-point melt peak analysis. The platform uses a unique, patented lysis reagent allowing for a five-minute lysis step, as well as common enrichment methods and a simplified workflow that is standardized for the different assays. It also features intuitive software, remote access, and room temperature storage of reagents, and it requires limited training to operate.
At launch, the test menu consisted of Salmonella, Escherichia coli O157:H7, and Listeria, with a Campylobacter assay on the way. All tests have internal controls and provide results within one hour.
But GeneUp won't replace the Vidas system. "It's meant as a complement or a supplement to the Vidas, so we'll be able to reach everybody in the marketplace no matter what their needs and preferences are," noted Bailey.
Indeed, the Vidas is "a well-respected platform in the food market," according to Tom Weschler, president and founder of Strategic Consulting, a market research firm that reports on this space.
"It is a workhorse platform, very dependable, and they have a sizeable installed base," Weschler said.
The strategy to date appears to have been to continue to expand the offerings on the Vidas and to enhance its performance, Weschler said. "They have done a number of clever things with the capture technology [and] the specificity, so their Vidas platform in many applications is equal in performance to molecular methods," he said.
But BioMérieux may have felt a market pressure and a need to round out its product line, Weschler speculated, such that "If a customer was going to switch to molecular, BioMérieux felt 'they might as well switch to ours.'"
The food testing market fits into an overall industry market, or non-clinical diagnostic testing market, that consumes 2 billion tests per year and has a value of $6.5 billion, according Weschler.
The compound annual growth rate for test volume in the industry market is about 5 percent, but the market value is actually growing at a rate of around 6 percent due to a shift from traditional methods to newer methods that typically carry a higher price per test, he said.
To derive its microbiology food testing market reports, Weschler's firm conducts detailed interviews with more than 450 global food production facilities each year.
Food testing makes up about half of the industry market, and accounted for around 1 billion tests in 2014 with a market value of about $3.2 billion, Weschler said.
These roughly 1 billion tests break down to 311 million tests in North America, 316 million in Europe, and 393 million in Asia Pacific and the rest of the world.
These assays can be further subcategorized into routine microbiology testing and pathogen microbiology testing.
Pathogen testing for things like Salmonella, Listeria, Campylobacter, or pathogenic E. coli made up 240 million of the total global test volume in 2014, Weschler said, while generic indicator tests for things like total bacteria, yeast and mold, and non-pathogenic coloforms, constituted the majority of tests run.
Interestingly, the market value is about equal for routine and pathogen tests, at $1.6 billion each, because the average price per test for pathogen testing is much higher than for routine tests, Weschler explained.
The CAGR for the food testing market is a bit higher than for the overall non-clinical market, with test volume growing at a rate of about 5 percent and market value growth of 6 percent. Weschler attributed this growth to a number of factors, including federal regulations, proactive efforts by food companies, and requirements of food retailers.
"Some of it is also reactive by food companies, to avoid issues like Chipotle is going though right now," he said, referring to the outbreaks of foodborne illness at Chipotle restaurants that have led to massive financial losses for the chain and resulted in its recent commitment to establish itself "at the forefront of food safety protocols in the restaurant industry," according to a recent statement.
Specifically, an outbreak of Shiga toxin-producing E. coli O26 associated with the restaurants late last year sickened 53 customers in nine states, according to the US Centers for Disease Control and Prevention.
And while that outbreak was due to contamination of an unknown food ingredient, a single Boston Chipotle restaurant was the source of a norovirus outbreak that resulted in more than 100 illnesses, possibly caused by a sick employee preparing food.
Chipotle has since hired outside testing lab IEH Laboratories and Consulting to evaluate its products. This includes "high-resolution testing of all fresh produce in which a series of DNA-based tests will ensure the quality and safety of ingredients before they are shipped to restaurants," the firm said.
Of the 240 million pathogen tests in 2014, traditional microbiology methods were used in half of these, Wechsler said, but different geographic regions also seemed to prefer different test methods.
In the geographic bucket called Asia Pacific and rest of world, 80 percent of tests were traditional, compared to 53 percent in Europe.
But in North America, only about five percent of food pathogen tests use traditional culture-based methods. Instead, more than half of all testing was antibody-based, and molecular methods were "gaining market share," Weschler said, noting that they represented about a third of the market.
Weschler said there are currently about 15 firms offering molecular-based tests for food, but this is a recent development.
Up until 2000, the two dominant product lines had been BioMérieux's Vidas immunoassays and DuPont's BAX real-time PCR-based molecular platform.
"What has happened since 2005 or so is the launch of 15 different molecular platforms by companies like Merck Millipore, Bio-Rad, Thermo Fisher, Qiagen, Roka Bioscience, Bio Control, NeoGen, 3M, and others," Weschler said.
Now, "All of the major players in the food micro diagnostics market have come out with molecular, and frankly it is getting quite difficult to differentiate one from the other — customers have the advantage of what I'll call 'switchability' because there are many good competing methods."
Similarly, developers of new molecular technologies wishing ultimately to enter the human clinical market with US Food and Drug Administration-approved test platforms sometimes go the route of first garnering revenues by developing tests for applied markets, where the barrier to entry seems lower.
"There are requirements ... but many will say that the certification or approval requirements to compete in food micro diagnostics are not as onerous as for human clinical," Wechsler explained.
Some have been successful with this strategy, he said, but others have found that while approval may be easier, getting traction and market acceptance can be difficult.
"It's not a trivial task to come and compete in the food space, especially given the number of people that are now in that space."
However, at some point this will consolidate, Weschler predicts, and pricing pressure from outside testing labs may impact this. The majority of food testing is done on samples collected at food production facilities, and not much testing is done at farms, after food is produced, or at food retail settings.
Thirty years ago, more than 95 percent of food samples were collected at food factories and then analyzed on-site, in plant laboratories.
But outside analysis of food products is a segment of the testing market that is growing particularly rapidly, Weschler said.
This began when food plants brought in consultants to tackle microbiology issues, and these consultants in turn set up testing laboratories.
One such third-party company, Silliker labs, was acquired by BioMérieux's parent company Institut Mérieux in 1997, and is now part of a network of 80 food testing labs worldwide called Mérieux NutriSciences.
A number of sizeable third party labs have been established over the past 30 years, Weschler said, and food factories are now faced with the option of maintaining labs in-house or sending out testing.
"For several reasons, more companies are choosing to send at least pathogen testing, if not all of their micro testing, to these third-party laboratories," Weschler said, noting that this is particularly the case in North America.
Some of this trend is attributable to an increased complexity of testing, as well as an impression among consumers of better credibility from outside labs.
"It is important because these testing laboratories are consolidating volume and are gaining more power in the purchasing of the diagnostic methods," Weschler said.
"They're more skilled in their purchasing, and so now the diagnostic companies — like BioMérieux, Thermo, Merck Millipore, 3M, or NeoGen — instead of just focusing on the food plants have to now try to gain acceptance with these third-party laboratories."
Interestingly, while ISO 17025 accreditation of testing labs is only indirectly mentioned in FSMA, it is directly discussed by industry groups such as Global Food Standards Institute, and GFSI standards are being increasingly adopted by food companies.
"In North America, maybe 20 percent of food microbiology labs at the plants are ISO 17025 accredited, whereas 100 percent of the third-party laboratories are accredited," Weschler explained.
Accreditation requires performance and quality testing as well as documentation, and it can be a burden on the food plants. So, although the majority of testing is still done on-site, there is a shift to outsourcing testing, said Weschler, and third party test labs — Mérieux NutriScience, Eurofins, and SGS, globally, as well as labs like Food Safety Net Services in North America — seem to be influencing competitive dynamics in this market.
"They will make business decisions on which method to use based on throughput, ease of use, and price, but they do have a big stick and as a result they can negotiate very good prices, perhaps better prices than food companies could — they act as a consolidation point and have that much more volume," Weschler said.
These labs also tend to have more skilled technicians that food plant labs do, so they can substitute in new tests more easily in response to pricing changes.
BioMérieux's Bailey said implementation of FSMA in 2011 also appears to have driven testing to third parties, since companies are required to document that the preventative controls used in food production are working. And enforcement of FSMA will likely increase in the near term because the latest federal spending bill allots it $1.1 billion, fully funding it for the first time.
Meanwhile, the BioMérieux's Agri-Food Solutions division has a dedicated marketing and sales force, and GeneUp will be "an additional tool in our toolbox," Bailey said.
On the horizon, BioMérieux may consider something akin to the FilmArray syndromic panels for the industrial side. The CEERAM food-related molecular virology tests, including ones for noroviruses and hepatitis A, will also be developed for the GeneUp molecular platform, and Bailey suggested the future of testing will involve looking for specific virulence factors and serotypes rather than just a particular organism.
With the total food testing offering, BioMérieux will "be able to reach everybody in the marketplace no matter what their needs and preferences are," Bailey said.