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BioMerieux's Vitek MS Wins FDA Clearance as Firm Battles Bruker in US Clinical Microbiology Market

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The US Food and Drug Administration said this week that it has granted BioMérieux's Vitek MS clinical microbiology mass spectrometry system 510(k) de novo clearance.

The system, which uses MALDI-TOF mass spec to identify disease-causing organisms including bacteria and yeast, is the first such platform cleared for clinical use in the US. As such, the approval represents a significant step forward for the technology, Robin Patel, director of the Mayo Clinic's Infectious Diseases Research Laboratory, told ProteoMonitor, calling it "a milestone for MALDI-TOF mass spectrometry for microbiology."

The FDA clearance also provides the Vitek MS with an advantage – albeit likely a temporary one – as it battles Bruker's competing MALDI Biotyper device for share of the US clinical microbiology market.

Launched in 2006, Bruker's Biotyper was the first MALDI-based microbial ID system to market, with the Vitek MS arriving five years later in 2011. Both devices have the CE-IVD Mark and are available for clinical use in Europe, but Bruker has managed with its significant head start to establish itself as the dominate player in this market.

As Nathan Ledeboer, medical director for the clinical microbiology and molecular diagnostics laboratories at Milwaukee's Froedtert Hospital, told ProteoMonitor, however, the US market is much more evenly split between the two vendors.

Bruker has made a 510(k) submission for its Biotyper platform and is awaiting a ruling from FDA. For the time being, though, only the Vitek MS is approved for clinical use.

Both 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-based platforms like the Vitek MS and Biotyper, can offer improvements in speed, price, and accuracy.

According to BioMérieux, the Vitek MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated run. Each test takes about one minute, compared to hours or days for conventional methods.

"The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health, said in a statement this week announcing clearance of the Vitek MS platform. "Rapid identification of harmful microorganisms can improve the care of critically ill patients."

For its 510(k) application, BioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates. The Vitek MS platform's accuracy was compared to 16S Ribosomal RNA gene sequencing, the current gold standard, for the following categories of microbial pathogens: anaerobic bacteria, Enterobacteriaceae, Gram-positive aerobes, fastidious Gram-negative bacteria, Gram-negative non-Enterobacteriaceae, and yeast. The overall accuracy of the Vitek MS compared to nucleic acid sequencing for these organisms was 93.6 percent, the company said.

Christine Ginocchio, senior medical director and chief of the Division of Infectious Disease Diagnostics at North Shore-LIJ Health System Laboratories, told ProteoMonitor that while her organization has been holding off on using the Vitek MS for clinical work due to regulatory concerns, she and her colleagues are ready to begin using the platform for patient care following the FDA clearance.

"We're very excited, ready to go," she said. "The lab can't wait to switch over. Your whole workflow changes. You can get an organism ID in a couple of minutes, basically, compared to waiting 24 to 72 hours for a traditional identification. And that has a huge impact."

Indeed, in a study published in December in the online edition of Archives of Pathology & Laboratory Medicine, clinicians at Houston's Methodist Hospital found that using Bruker's Biotyper as part of its antibiotic stewardship program reduced average patient stays by 2.6 days and average hospitalization costs from $45,709 to $26,162 per patient (PM 5/24/2013).

The flip side of such a finding, however, Ginocchio noted, is that without the necessary infrastructure in place, the rapid IDs provided by MALDI-based systems will largely go wasted. Given this, she said, hospitals need plans for integrating the information provided by these systems into their larger practice.

"We go to a lot of lengths to get these results very quickly, but if nobody is going to act on [an ID] until 18 hours later, then all the benefit is really lost," she said. "We had a meeting at the beginning of this week with our pharmacy groups and our [doctors of pharmacy] to take a look at how fast we can get this information and how we are going to put a process in place to make sure the information is acted on … and we can measure those outcomes."

Ginocchio and her colleagues at North Shore-LIJ led one of the studies used by BioMérieux in its FDA submission and, she said, she thought the clearance could lead some clinical labs to move from Bruker's Biotyper to the Vitek MS platform.

Patel, whose lab has been using the Biotyper as its primary method for routine identification of bacteria, yeast, and dermatophytes in clinical specimens in advance of the device receiving FDA approval, said, however, that given the likelihood of Bruker receiving clearance for the Biotyper in the near future, the Vitek MS clearance is unlikely to drive users of one platform to shift to the other.

"For a laboratory to switch systems is not something that you would do on a dime because of all the logistics involved – acquiring instrumentation, validation, training," she said. "All of that would take several months to do, so it wouldn't be a decision that anyone would take lightly."

She added that while she had no insight into the particulars of Bruker's regulatory submission, based on her experience using the Biotyper system, she "wouldn't expect [FDA clearance] to be a problem."

Ledeboer, whose lab also uses the Biotyper system, likewise said he didn't think that the Vitek MS clearance would drive current Bruker customers to the BioMérieux system, adding that, given that Bruker made its 510(k) submission around a month after BioMérieux, he expected the Biotyper would receive FDA clearance shortly.

He added that this was likely the first of many FDA submissions for the two firms, noting that they will have to file for additional clearances as they expand their platforms' databases and capabilities.

Nonetheless, Ledeboer said, the clearance "obviously gives BioMérieux a very significant advantage over the next few weeks, or for as long as they are the only ones with FDA approval, in terms of going out there and letting everyone know and seeing what you can get in terms of sales."

In an email to ProteoMonitor, BioMérieux said the number of Vitek MS systems currently installed in the US is in the double digits and that the company plans "an aggressive effort to expand that footprint now that the 510(k) de novo clearance has been granted by the FDA."

The company said it estimates that around 800 labs in the US "have the volume necessary to acquire the Vitek MS," though it noted that "volume alone will not be the only factor for many hospitals," adding that "this calculus will vary from hospital to hospital based on their patient populations, demographics, and infection rates."

BioMérieux said that it has begun technology upgrades at its current US clinical installations to allow use of the FDA-cleared Vitek MS and expects to complete this process in the next few months.

The Vitek MS is also approved for clinical use in China as well as a number of additional Asian and Latin American countries. In addition to the EU, Bruker's Biotyper is approved for clinical use in Australia, New Zealand, Taiwan, and Japan.

There are roughly 800 Biotypers installed worldwide, versus around 400 Vitek MS units.

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