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Turnkey Clinical Mass Spec Solution on Horizon, Industry Analyst Suggests


NEW YORK (GenomeWeb) – For years now mass spectrometry has been slowly but steadily making its way toward the clinic, as potential benefits like improved analytical performance, better multiplexing, and cost savings have driven researchers, vendors, and clinicians to tackle the various challenges hindering the technology's broad adoption.

Coming out of the Mass Spectrometry: Applications to the Clinical Lab annual meeting last month, analysts with investment bank Leerink Partners issued a research note suggesting that the arrival of a true clinical mass spec system could soon be upon us.

The Leerink report predicted that Thermo Fisher Scientific could launch a "complete turnkey" mass spec system either later this year or in early 2018 and further suggested that such a release could help expand the clinical mass spec market from its current size of between $150 million and $200 million to more than $600 million, while increasing mass spec penetration of the roughly $7 billion immunoassay market.

Puneet Souda, an analyst at Leerink covering the life science tools and diagnostics industries and one of the authors on the note, said he believed Thermo Fisher was currently leading the race to a turnkey clinical mass spec due to its understanding of and assets in both the mass spec and immunoassay businesses, as well as what he said were significant investments in the effort.

"I believe Thermo is the most likely to do this," he said in an interview. "They have a large mass spec diagnostics program. They have been working on this for some time."

He cited the company's recent Q4 2016 earnings call during which Thermo Fisher CEO Mark Casper noted that it has "a fairly large program in clinical mass spectrometry," adding that it expected this program to have an impact in 2018.

SISCAPA Assay Technologies CEO Leigh Anderson, a clinical mass spec expert and close observer of the industry, said, however, that Thermo Fisher was not certain to be first to market with such a solution, and that, even if it were, systems from other vendors would likely follow.

He added that mass spec vendors could face competition in this space from established in vitro diagnostics firms like Roche and Abbott.

"Evidence continues to grow that at least one major IVD company is building an MS on a track system," Anderson said, though he did not specify what that evidence was. He said that such an instrument could present "a major barrier to entry for the MS instrument [vendors]."

Anderson and Souda both noted that the key challenge currently facing clinical mass spec is developing systems that can be run with far less user interaction and expertise than current instruments and that are seamlessly integrated with existing immunoassay production lines.

"You essentially have to make it turnkey so there is a process set up to where you are essentially clicking four buttons and then you walk away from the instrument," Souda said. "That level of automation today doesn't exist in triple quads."

The importance of integration into existing clinical track systems is that "it allows delivery of sample to any instrument on the track, which means that the lab can avoid aliquoting part of the sample into another labeled tube, carrying it manually to a different standalone instrument, etc.," Anderson said. he added that while most large IVD firms sell track systems designed to keep other vendors' instruments off them, there are some generic track providers that allow users to connect instruments from various vendors on a track.

He noted, though, that he was not currently aware of any mass spec vendor platforms being developed to attach to a clinical lab track system. "Which would mean they are standalone boxes in the [laboratory-developed test] mold, and not tightly integrated into the high-volume lab operations."

Souda suggested, though, that Thermo Fisher is at work on such a system. "The challenge is how to package it and present it on an immunoanalyzer line, basically," he said. "This is a pain point that they are aware of."

Asked about this challenge, Lisa Thomas, senior director, clinical and forensic markets, chromatography and mass spectrometry at Thermo Fisher, did not say if the company was working on such an instrument, but noted that it was "seeing similar market interest for an LC-MS which can fit within the current laboratory workflows."

"Our product pipeline investments are focused to ensure we can meet the expanding market trends and needs for mass spectrometry in the routine clinical laboratory," she said.

Brian Murphy, a spokesperson for mass spec developer Waters, indicated that that company is likewise focused on this question, though he didn't provide any specifics regarding efforts to tackle it.

"Since the late '90s, clinical labs have adopted mass spec at a steady pace, but its adoption has been slowed by the time, effort, and expertise required to support it in the highly automated environment of the modern clinical laboratory," he said. "Over the years, most of the traditional mass spec vendors have taken steps to address the automation gap by automating data transfer to and from various laboratory systems, but a more difficult challenge remains, and that is sample preparation automation."

"Stand-alone liquid handling systems are common, but samples have to be manually loaded onto them and then moved manually from the sample handling device to the mass spec," he added. "The sample preparation step and mass spec analysis is still an offline activity."

"The next logical step for vendors is to build a true mass spec-based clinical analyzer and integrate it with the track system along with the sample preparation device," Murphy said. "This would remove a significant barrier to wider adoption of the technique."

Souda said he believed Thermo Fisher was best positioned to take this step due to the fact that it already has both a mass spec business and an immunoassay and immunoanalyzer business through its Phadia division. It could be argued, though, that Sciex is similarly positioned given the immunoassay business of its Danaher stablemate Beckman Coulter. Sciex declined to comment for this story.

Sciex is far and away the leading provider of triple quadrupole instrumentation, which has traditionally been the most common clinical mass spec format. Waters and Agilent Technologies also outpace Thermo Fisher in terms of triple quadrupole sales.

Souda said, though, that this was of little relevance to turnkey clinical mass spec efforts.

"It is not about the triple quad itself," he said. "It is actually more about essentially understanding the immunoassay, immunoanalyzer markets, and understanding what that market needs."

"The key here is not only having a turnkey mass spec, but, more importantly, getting the regulatory approvals, because all of the assays that are currently in the market are approved by [the US Food and Drug Administration], so having a broad menu available with a turnkey mass spec in an approved fashion, that is what will be transformative," he said. "And I think Thermo can do that because Thermo have been working on this for a long time."

Souda said that he was aware that traditional IVD firms have been investing in mass spec technology, but, unlike Anderson, he said he didn't currently consider them serious competitive threats to traditional mass spec vendors' efforts in the clinical space.

"Those investments have been going on for quite some time and nothing realistic has come out of it," he said.

Anderson said, though, that he believed that potential competition from IVD firms meant mass spec vendors were "making a serious mistake aiming for what they view as low-hanging fruit — [assays to] vitamin D, steroids, immunosuppressants — while neglecting the much more valuable and disruptive opportunity to replace protein immunoassays."

Mass spec-based protein analysis is the focus of SISCAPA's business and much of Anderson's research, some of which he has conducted with vendors including Agilent and Bruker.

He also suggested that for mass spec to truly become a widespread clinical tool, researchers would need to find a way around liquid chromatography.

"Everyone I talk to in this game realizes that LC is the primary factor limiting clinical uptake of mass spec," Anderson said. "LC is less than perfectly robust, the cost of LC columns as a consumable ends up being a significant factor in test cost, and the systems are inherently slow."

"Eliminating LC should be the technology goal, and once this is accomplished then serious test multiplexing and cost reduction is really on the table," he added.

Perhaps uncoincidentally, mass spec's greatest clinical success to date — microbial identification — has used MALDI, which does not require upfront LC separations and is significantly more straightforward to use than LC-MS systems.

Souda noted that LC separation is helpful when measuring analytes in complex matrices. However, researchers including Anderson have been exploring, with some success, the possibility of using MALDI for protein quantitation, which could position the technique as a competitor to traditional immunoassays.

For instance, last year, clinicians at the Mayo Clinic developed a MALDI mass spec assay for monitoring levels of monoclonal proteins (M-proteins) in patients with plasma cell disorders like multiple myeloma, which they plan to begin offering for routine use the middle of this year.