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MALDI Clinical Microbiology Releases Bring New Features, Could Open Additional US Markets

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NEW YORK – It has been an eventful time for MALDI-based clinical microbiology as the market's two largest players have released updated instruments in recent years and a new entrant is waiting in the wings.

These developments have brought improved technologies and new capabilities to the space as well as compact form factors and more flexible pricing that could help MALDI instrumentation make inroads with the smaller microbiology labs where it has had less of a presence to date.

In March, BioMérieux announced that its Vitek MS Prime MALDI-TOF system had received 510(k) clearance from the US Food and Drug Administration. The instrument, which received the CE mark last year and is now available throughout Europe, the US, and some Asian and Latin American countries, is an updated version of the company's Vitek MS, which received FDA clearance in 2013.

Bruker's original MALDI Biotyper also received FDA clearance in 2013. In 2019, Bruker launched an updated version of that system, the MALDI Biotyper Sirius, which offers new features including the ability to run in negative-ion mode, enabling the more effective analysis of certain molecules like lipids, which researchers are exploring for applications like detecting antibiotic-resistant organisms and identifying bacteria directly from tissue. These new applications are currently available for research use only, however.

Meanwhile, Chinese firm Autobio Diagnostics said it plans to submit its Autof MS 1000 MALDI microbiology system for FDA clearance. Launched in 2017, the instrument has been approved for clinical use in China and Europe. Its US distributor, Santa Maria, California-based Hardy Diagnostics, is currently working on an FDA submission, according to Hardy CSO Andre Hsiung. In the meantime, he added, the firm is marketing the system to academic and research customers in the US. In several studies published comparing it to the Bruker and BioMérieux systems, it has shown broadly comparable performance.

The recent releases, along with the fact that the original MALDI microbiology systems launched almost a decade ago, indicate that the market is prime for a refresh, said Nathan Ledeboer, professor of pathology and medical director of microbiology at the Medical College of Wisconsin.

"If you look at a lot of the early adopters of MALDI, those instruments are probably getting close to [being] or exceeding 10 years old at this point in time," he said, adding that a likely driver of the new releases and updates was companies "getting ready for labs that were early in the adoption cycle to start replacing their original systems."

Ledeboer said he was familiar with the Autof MS 1000 system but could not comment about it due to a nondisclosure agreement related to research involving the instrument.

MALDI microbiology systems identify microbes by matching the MALDI mass spec protein profiles of organisms in a sample to profiles contained in a proprietary database. Compared to traditional biochemical methods of microbe detection, MALDI-based systems can offer improvements in speed, price, and accuracy. Within large hospital systems and academic centers that do a high volume of microbial ID work, MALDI has become a standard piece of equipment over the last decade.

The technology has made less headway in smaller labs, however, said Omai Garner, director of clinical microbiology at the University of California, Los Angeles Health System.

"If you look at the academic medical centers like mine, basically all of them have one," he said. "And the larger systems like Kaiser, Geisinger, places like that have them. But that only accounts for 20, 30 percent [of labs]."

Garner said that while the instrument updates offered certain technical improvements, he believed issues like instrument size and pricing would be key for determining not only whether existing customers upgraded to the new systems but also whether those platforms would penetrate the market of smaller clinical microbiology labs that have not yet taken up MALDI.

Existing instruments already offer rapid identifications and high-quality libraries, "so I don't see a dramatic shift in capabilities," he said. "I see some workflow improvements, space improvements, and potentially some cost improvements — that's what would really drive my own decision making in whether or not I am going to upgrade my Vitek MS to Vitek's next system."

Ledeboer cited features like better vacuum pumps, which can reduce maintenance downtime and allow clinicians to change MALDI targets more quickly, as notable improvements. He also highlighted the ability of the new Vitek system to move particular samples to the front of the line, allowing for STAT testing of high priority specimens.

Both Garner and Ledeboer said the packaging of MALDI systems as benchtop instruments was notable. The Bruker, BioMérieux, and Autobio platforms are all now benchtop systems.

"For a lot of labs, space is a big issue," Ledeboer said. "You don't ever hear a laboratory director saying, 'I have too much space. I don't know what to do with it.' It's always the other side of the argument."

Karen Pinkston, senior global product manager for global marketing blood culture, ID and AST at BioMérieux, said that in discussions with customers about how to improve the original Vitek MS, items like smaller footprint, fewer hands-on steps, and less instrument downtime were key requests.

Among the features the company added to the Vitek MS Prime in order to address these concerns were an internal barcode reader for tracking samples and an "automated fine-tuning" feature that lets labs tune the instrument without requiring a site visit from a company tech.

Pinkston also cited as a key improvement for the new Vitek that slides for a given run don’t have to be all loaded at once.

"With our new system, customers can walk up to the instrument and load one slide at a time, up to 16 slides, so it really addresses that bottleneck," she said.

While the new systems offer various improvements in terms of workflows, form factor, and maintenance, there has been little to no movement on pricing, which could hamper MALDI's move into smaller clinical microbiology labs. MALDI clinical microbiology systems typically cost in the range of $250,000 to $300,000.

Pricing "is basically where it was a decade ago, or even just a little bit higher," Ledeboer said. "It still does very much create a situation where smaller laboratories, especially laboratories in underserved or rural areas, may have a more difficult time justifying the cost of one of these instruments because they don't have the kind of volume that a larger laboratory would have."

Ledeboer said that "certainly [vendors] want to be able to place more instruments … and they are willing to get creative in terms of what specific [purchase] programs look like."

He added, though, that interest in making MALDI accessible to smaller labs is countered somewhat by a broader trend with clinical microbiology toward more centralization, especially for the routine bacterial ID work for which MALDI is commonly used.

One challenge microbiology labs face in purchasing a MALDI instrument is that because the systems use very little reagents, the sort of reagent-rental model common in other parts of the lab isn't typically an option. On the one hand, that means reagent savings can be significant. A 2015 analysis by clinical microbiologists at University of North Carolina Health Care found that the savings provided by their MALDI system paid for the cost of the instrument in about three years. Laurie Mras, microbiology manager at Cayuga Medical Center in Ithaca, New York, said that her lab saved around $20,000 per year in consumable costs after switching to MALDI in 2016. However, because a reagent-rental model isn't feasible, it means labs must come up with the money for the purchase upfront, which can be challenging.

Mras said that she and her colleagues at Cayuga projected moving to MALDI would save around $40,000 per year while also allowing the lab to capture new testing business from surrounding hospitals. Even so, it still took them three years to get approval from the hospital for the purchase.

"Capital money is very competitive," she said. "We really had to prioritize what needed to be replaced and what we wanted to invest in."

Mras said that the COVID-19 pandemic has made getting this money even more challenging.

"There are a lot of labs in our area that don't have this technology and want it," she said. "I know several of them had it in their capital budget, but I think that with the pandemic, they were like, 'OK, now we're not getting anything.' I think if they were getting anything, they were going to get a machine that could do COVID-19 [testing]."

Pinkston said that BioMérieux was working to make its MALDI systems more affordable, noting that the company has implemented some flexible financing options, such as rentals and placements.

Hsiung suggested that when the Autof MS 1000 enters the US clinical market, it could provide a lower-priced alternative attractive to smaller labs. "Being not the first to enter the market, the intent is to make the testing more affordable, thus making penetration possible into the mid-to-smaller-sized hospitals, food testing labs, and other markets through direct sales and leasing programs," he said.

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