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Bruker Wins FDA Clearance for MALDI Biotyper, Opening up US Clinical Market


Having last week received US Food and Drug Administration 510(k) clearance, Bruker's MALDI Biotyper is now approved for clinical microbiology work in the US.

With the clearance, the Biotyper joins its primary competitor, BioMérieux's Vitek MS system, which received 510(k) clearance in August. US hospitals and other facilities that have been waiting on FDA clearance to begin using the system can now implement it as part of their clinical workflows.

Launched in 2006, the Biotyper was the first MALDI-based microbial ID system to market, beating the Vitek MS, which launched in 2011, by five years. Bruker has used this head start to establish itself as the dominant MALDI microbiology player in Europe, where both systems have the CE-IVD mark and are available for clinical use. The US market, however, is more evenly split between the two vendors, with BioMérieux over the last several months enjoying a brief head start of its own in this market.

With last week's approval, Bruker evened the score somewhat, but the Vitek MS still enjoys an advantage in terms of the breadth of its databases. BioMérieux's 510(k) clearance covered the Vitek MS system itself along with databases covering Gram-negative bacteria, Gram-positive bacteria, yeast, and anaerobes.

Bruker's 510(k) clearance, meanwhile, covered the Biotyper system and a Gram-negative bacteria database. The company has since launched clinical trials for databases covering Gram-positive bacteria and yeast and hopes to submit these to FDA in Q1 2014, George Goedesky, executive director of marketing and business development at Bruker, told ProteoMonitor.

The Biotyper submission marked one of Bruker's first clinical trials. BioMérieux, on the other hand, has significant clinical trial experience, a factor that could give it an advantage in terms of future database expansion.

Goedesky said, though, that Bruker had made investments into regulatory affairs in order to move the Biotyper through FDA and that "further investments are being made as Bruker is committed to continued expansion of claims." He noted that both the Biotyper and the Vitek MS submissions took roughly the same amount of time to obtain clearance – with BioMérieux submitting in December 2012 and receiving clearance in August of this year, and Bruker submitting in March 2013 and receiving clearance in November. The BioMérieux submission, however, consisted of a significantly larger database.

Competitive dynamics aside, Biotyper's clearance marks another step in MALDI mass spec's move into clinical microbiology, clearing the way for labs to begin using the technology with the FDA's blessing. While some US hospitals began using the Biotyper and Vitek MS for clinical work prior to their clearance, many others have been preparing to take these systems live as soon as FDA gave its go-ahead, Nathan Ledeboer, medical director for the clinical microbiology and molecular diagnostics laboratories at Milwaukee's Froedtert Hospital, told ProteoMonitor.

"We are fully implementing [the Biotyper] now," he said. "We had really worked up how we would use it and got our procedures and everything in place so that we would be ready to go as soon as the FDA approved it."

Ledeboer and Froedtert are using the Biotyper for routine identification of all Gram-negative organisms using Bruker's databases as well as for identification of organisms including yeast and mycobacteria using databases developed and validated in-house.

Both the Biotyper and Vitek MS 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 systems can offer significant improvements in speed, price, and accuracy.

For instance, Ledeboer said, his lab determined that by moving from biochemical-based identification to MALDI, it could save an average of $4 to $5 per test. Given Froedtert's test volumes, that would amount to annual savings of around $300,000 — enough to pay back the cost of the instrument in around nine months, he said.

And, he noted, these calculations don't take into account the potential savings and benefits to patient health provided by more rapid identification of microorganisms. In a study published in December 2012 in the Archives of Pathology & Laboratory Medicine, clinicians at Houston's Methodist Hospital did attempt such an analysis. The researchers found that using the Biotyper as part of the hospital's antibiotic stewardship program reduced average patient stays by 2.6 days and average hospitalization costs from $45,709 to $26,162 per patient.

Ledeboer said that many academic hospitals have either already purchased a MALDI system for their clinical microbiology labs or budgeted the money for one. He added that large clinical reference labs would likely also "jump on [MALDI technology] very quickly because of the cost and turnaround time reductions."

After these labs, Ledeboer suggested that larger community hospitals presented the next "big area where we are going to see the progression of [MALDI] mass spec" for clinical microbiology.

While these facilities might not have as much volume as large academic centers, "depending on each institution's requirements for return on investment, even an institution performing as few as 5,000 identifications per year can cost justify [a Biotyper or Vitek MS] in a three-to-five-year period," he said. Both systems sell for around $200,000 to $250,000.

Goedesky suggested that Bruker's experience in Europe might serve as an indication of how adoption of the device in the US would proceed. "At first the market was made up of large academic centers and has expanded to include community-based hospitals," he said. "We think the same would happen in the US, but in what timeframe remains to be seen."

Ledeboer said that based on estimates he had seen, the US market for MALDI-based clinical microbiology systems was in the range of 1,000 to 2,000 labs. There are roughly 1,000 Biotypers installed worldwide, versus around 400 Vitek MS units.

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