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BD, Bruker Expand MALDI Microbiology Deal Aimed at Offering Complete ID/AST Solutions

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NEW YORK (GenomeWeb) – Last month Becton Dickinson announced an expanded distribution agreement for various of Bruker's mass spectrometry-based microbiology products with the goal of further fleshing out its MALDI-based microbiology offerings.

The deal added to the two companies' existing global distribution agreement for Bruker's MALDI Biotyper Biotargets; disposable MALDI plates suitable for multiple uses; its MALDI Sepsityper, a sepsis management kit for use on the MALDI Biotyper platform that allows for pathogen identification directly from blood cultures; and its MALDI Biotyper smart, a faster, higher-throughput version of the Biotyper platform that Bruker released in 2015.

The agreement represents "an expansion of our distribution, marketing, and commercial presence for solutions related to Bruker's MALDI Biotyper," said Steve Conly, BD's vice president and general manager of microbiology.

The covered products are "technology … that Bruker has historically sold directly or through other distributors," he said. "And so you can imagine that if a customer buys a [Biotyper] from BD, which many people have done, and yet they need to then go through another supplier to buy consumables, it hasn't necessarily been the most seamless experience."

The relationship between BD and Bruker began in 2010 when the companies formed a co-development and co-marketing agreement for microbial identification technologies that combined Bruker's MALDI Biotyper system with BD's Phoenix Microbiology System.

The firms expanded the agreement in 2013 to include international distribution of the co-labeled BD Bruker MALDI Biotyper system.

The relationship has been key to Bruker's efforts to build its research and clinical microbiology business. While the company is the developer of the MALDI Biotyper platform and related kits and consumables, it has little in house in the way of traditional microbiology offerings.

On the other hand, BioMérieux, Bruker's main competitor in the MALDI microbial ID space, offers a wide range of tests and instruments for microbial research and clinical applications. In a way, BioMérieux's situation is a mirror opposite of Bruker's, as the former sources the MALDI mass spec used in its VITEK MS microbial identification system from Shimadzu.

For BD, the Bruker relationship allows it to offer MALDI microbial identification technology to its existing and potential customers, an offering that has grown increasingly relevant in recent years as both Bruker's and BioMérieux's MALDI systems have obtained clinical approval in markets including the EU, US, and China, and use of MALDI in clinical microbiology has rapidly expanded.

MALDI-based platforms identify microbes by matching the protein profiles of sample organisms generated via MALDI mass spec to profiles contained in a proprietary database. Compared to traditional biochemical methods of microbe detection, MALDI systems can offer significant improvements in speed, price, and accuracy.

Conly said that one side of the business — traditional versus mass spec-based — was not necessarily more of a factor than the other in terms of driving customer adoption, but he noted that there are "customers who have for many years had automated phenotypic identification and susceptibility systems [like those traditionally offered by BD], and I believe that they recognize the value that MALDI brings to their laboratory through increased accuracy, faster time to results, high cost efficiency on a per-test basis, and very low reagent [needs]."

"You have some customers who are just looking to get a MALDI, and you've got many customers who are looking for an identification and [antibiotic susceptibility testing] solution (ID/AST)," he said.

BD's Phoenix M50 offers susceptibility testing and can be integrated with the Biotyper to provide a full ID/AST workflow. Bruker and others have also been exploring MALDI as an approach to identifying antibiotic resistance, as well, and Conley said he saw a role for the technology in that portion of the workflow.

MALDI "provides a much more rapid identification, which many times can actually help to better optimize and tailor therapy depending on [the identity of] that organism," he said. "Obviously, the full result, which is the susceptibility result [provided by an instrument like the Phoenix] that comes afterwards will further help to optimize [treatment]. But even just the identification itself really helps to guide more appropriate therapy."

MALDI researchers and vendors are also pursuing the antibiotic susceptibility testing more directly than via the indirect benefit of more rapid microorganism identification. For instance, last week, researchers from Imperial College London presented on a study using MALDI mass spec to detect polymyxin resistance in Enterobacteriaceae by measuring mass spec features corresponding to modifications to bacterial lipopolysaccharides (LPS) that confer resistance to this class of antibiotics.

Similar approaches have been developed for the detection of carbapenem-resistant organisms. For instance, researchers from institutions including the National Institutes of Health and the University of Bologna have used MALDI to detect a peak specific to the pKpQIL_p019 protein, which is often present on the same plasmid as the bkaKPC gene. The bkaKPC gene produces the protein carbapenemase KPC, which can confer resistance to carbapenems.

Other researchers, including scientists at Bruker, are developing methods using MALDI mass spec to identify resistant strains by detecting the hydrolysis products generated by KPC. Bruker has also developed a method on the MALDI Biotyper for detection of carbapenem-resistant strains of Bacteroides fragilis and Staphylococcus aureus via detection of the presence of, respectively, the cfiA gene and the mecA cassette expressing the protein PSM.

The company recently introduced its MALDI Biotyper STAR-Carba assay, a CE-IVD marked assay for testing for carbapenem resistance on the MALDI Biotyper platform, which, Bruker President and CEO Frank Laukien said on a company earnings call this week is the first CE-IVD marked mass spec test for antibiotic resistance to come to market.

The extent to which mass spec-based susceptibility testing could cut into the market for conventional solutions like BD's Phoenix platform is unclear, as it is still early days for such applications. MALDI has the potential to significantly improve turnaround time for such applications, though. For instance, according to Laurent Dortet, one of the Imperial College researchers on the polymyxin study, conventional susceptibility testing can take from three to four days compared to one day for MALDI.

Conley said that while he had seen posters and papers on the use of MALDI for susceptibility testing, he wasn't able to comment on the performance of such methods.

He said that BD's main focus with regard to its relationship with Bruker remains expanding the presence of the existing MALDI technology and applications.

Some observers have suggested that the MALDI infectious disease market is maturing, which could lead to a slowdown in instrument sales, but Conley said that in various regions around the world BD still sees significant opportunities to drive increased adoption of the technology.

Bruker also recently moved into PCR-based microbiology testing, launching last month its Fungiplex Aspergillus identification and Carbaplex resistance gene assays. These tests are the first new products to come from Bruker's purchase last year of intellectual property and personnel enabling PCR test development.

Conley said he was aware of Bruker's move into this space but declined to comment on whether or not BD was interested in adding the PCR tests to the licensing agreement. BD already offers PCR-based microbiology tests including its BD MAX Enteric Bacterial Panel.

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