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Bruker Moving Into PCR-Based Testing to Expand Clinical Microbiology, MALDI Biotyper Offerings

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NEW YORK (GenomeWeb) – Bruker announced last week that it has acquired PCR technology assets with which it plans to build syndromic infectious disease diagnostics.

The assets include a laboratory in Glasgow, UK and intellectual property related to PCR. The company has also hired research and business staff to support the development, validation, and commercialization of the syndromic microbiology panels, Wolfgang Pusch, executive vice president for clinical MALDI solutions at Bruker, told GenomeWeb.

Bruker will release initial versions of the tests on conventional PCR platforms but plans to ultimately release PCR tests that use the company's MALDI Biotyper mass spec system for their readout, Pusch said.

This approach allows Bruker to move into the growing nucleic acid testing space while at the same time providing additional assays for the company's existing Biotyper users, he noted.

While mass spec is not commonly used for readout of PCR assays, it presents some potential advantages, Pusch said, noting that it "allows, in principle, for a higher degree of multiplexing than is possible with conventional techniques."

This could be useful for syndromic infectious disease panels, which test for the presence of multiple organisms to help determine what the specific cause of a patient's symptoms might be.

With such panels "you want to detect or possibly rule out a multitude of different microorganisms or viruses that might be the agent of a certain disease," Pusch said. "That by definition means that you need to have a rather high degree of multiplexing, and there MALDI-TOF mass spectrometry could provide an advantage."

The extent to which Bruker moves its PCR assays to a MALDI readout will depend, in part, on customer response," he said. "If the feedback is positive then, indeed, our long-term goal would be to transfer more and more assays onto the MALDI Biotyper."

Mass spec is not commonly used for readout of PCR assays but there are some commercially available examples. Agena Bioscience's MassArray system uses MALDI to readout its real-time PCR assays. Agena acquired the MassArray system in its $31.8 million purchase of Sequenom's bioscience business in 2014.

Abbott Molecular's Iridica pathogen detection system also uses mass spec as a PCR readout, though that platform is electrospray-based, rather than MALDI.

Addition of PCR assays will allow Bruker to provide customers a more complete microbiology portfolio, which could help it compete with BioMérieux, whose Vitek MS system is the Biotyper's primary rival in the MALDI-based microbial ID market.

BioMérieux has an extensive microbiology portfolio covering a range of conventional and molecular testing technologies. Bruker, on the other hand, "has relied on partners to help them get into laboratories and to drive utilization," Nathan Ledeboer, medical director for the clinical microbiology and molecular diagnostics laboratories at the Medical College of Wisconsin, told GenomeWeb. "This will give them a bit more of a complete solution."

Ledeboer also suggested that adding PCR testing will give Bruker an additional business to support what he anticipates will be slowing Biotyper sales.

"The fact is that MALDI as a market is maturing in infectious diseases, and they were not going to be able to maintain their growth with just a simple instrument-based [business] model," he said. "They really needed to find a way that they can generate a consumables business and continue to expand."

Pusch acknowledged the importance of adding content to the Biotyper test menu. "Generally, that is part of our strategy, to add more and more assays to our clinical MALDI Biotyper platform," he said. Beyond PCR, Bruker is working on new capabilities for the platform addressing uses like further improving its capabilities for the identification of fungi and mycobacteria as well as antibiotic resistance and susceptibility testing.

A report published last month in the Journal of Molecular Diagnostics by researchers from the Association of Molecular Pathology looked at several such emerging uses, noting that mycobacteria identification was perhaps the closest to clinical use, with fungal ID relatively close behind and antibiotic resistance and susceptibility testing somewhat further off.

Bruker has reported weakness in its Biotyper business recently. Sales of the platform were down in the US and China in the first half of 2016. During the company's Q3 earning call this month, President and CEO Frank Laukien said US Biotyper sales had risen since H1, but that the company was "not quite where we want to be yet." In China, the company resolved certain distribution issues that had dampened Biotyper sales, Laukien said, but he added that he did not expect growth to resume its previous trajectory until 2017.

Bruker has undertaken various restructuring efforts in recent years, including in its CALID division, which houses its life science mass spec business. According to the company's most recent 10-K filing, restructuring actions begun this year will eliminate roughly 125 employees in its CALID and Nano groups.

According to a source familiar with the company, Bruker has, as part of this restructuring, shut down US production of the Biotyper and laid off around 40 employees.

Pusch declined to comment on any consolidation within Bruker's Biotyper group and referred GenomeWeb to the company's public statements regarding its restructuring plans.

While the move into PCR represents an opportunity for Bruker, the company faces significant competition in the syndromic panel market, both from other companies in the PCR space and from newer technologies like next-generation sequencing, Ledeboer said.

"This is not going to be for Bruker as easy as, say, mass spec was," he said. "They are going into a market where there are a lot of entrants and a lot of competition. So they are going to have to compete in trying to develop panels and applications that people really, really need. Whether they can do it or not I think is a bit of an unknown."

As in the MALDI microbiology space, one of Bruker's main competitors in syndromic testing will be BioMérieux, whose subsidiary BioFire has "had a ton of success in terms of placing instruments and driving utilization," Ledeboer said.

He added that, thus far, syndromic panels for respiratory and bloodstream infections have seen significant uptake from clinicians, while "the jury is still out" on panels meningitis and gastrointestinal infections.

In addition to competition from other PCR test manufacturers and PCR-based panels more generally, Bruker will likely have to contend with new NGS-based tests, Ledeboer said.

"The question is, what role are these highly multiplexed syndromic panels going to play in comparison to next generation sequencers?" he said. "We don't have [a US Food and Drug Administration]-cleared sequencing application [in infectious disease] yet, so it's still a little bit difficult to know where that's going to fit in the clinical laboratory."

Pusch noted that Bruker's PCR ambitions don't end with microbiology. The company also plans to develop assays with MALDI-based readout for applications including food testing and pathology.

The latter would be a fit for Bruker's MALDI Tissuetyper instrument, which uses mass spec imaging for pathology applications. Bruker introduced that platform, which is based on its rapiflex MALDI-TOF instrument, last year at the American Society for Mass Spectrometry annual meeting.

"Molecular testing is a major field in pathology and is an application that has been brought to us already by some key opinion leaders who said that it might be very beneficial to also offer to PCR readout via MALDI," Pusch said. "So that is an opportunity that we are going to pursue in the long-term, as well."