NEW YORK (GenomeWeb) – Thermo Fisher Scientific said during its analyst day last week that it plans to launch a walkaway mass spectrometry-based clinical analyzer in 2018.
The announcement confirmed previous reports that the company was working on such an instrument, though it provided little information on what types of assays or molecules the analyzer might target, and it declined to comment further on its plans for the instrument.
Coming out of the Mass Spectrometry: Applications to the Clinical Lab annual meeting in January, analysts with investment bank Leerink Partners issued a research note suggesting that Thermo Fisher was developing a turnkey mass spec system. Mass spectrometry has for years slowly been extending its clinical reach, as potential benefits like improved analytical performance, better multiplexing, and cost savings have incentivized companies to tackle the various challenges hindering the technology's broad adoption.
During the company's analyst day presentation, Patrick Durbin, Thermo Fisher's senior vice president and president of specialty diagnostics noted that the company has "been for many years fascinated about the opportunity to take mass spec into the clinic and develop actually proprietary walk-away mass spectrometry-based analyzer."
Thermo Fisher's efforts in this area are "focused on providing superior clinical results compared to immunoassays in a walk-away, easier-to-use format that could end up in the hospital, he said, adding that the company planned to have more details to share in 2018.
In a research note following the analyst day announcement, Leerink analysts Puneet Souda and Kai Wang suggested the proposed instrument could win for Thermo Fisher part of the $7 billion immunoassay market currently dominated by firms including Roche, Siemens, Abbott, and Danaher.
A Barclays' analyst note from this month likewise noted the commercial potential of the company's planned mass spec-based clinical analyzer, suggesting that the instrument "could be disruptive" and have a potentially "meaningful" impact on Thermo Fisher's top-line growth.
The analysts said that they believed "hospitals will be the natural customers for the new offering," but added that "Thermo Fisher also has strong reach into LabCorp and Quest who could adopt the offering."
The company is well positioned among mass spec vendors to move toward the clinic given that it already has both a mass spec business and an immunoassay and immunoanalyzer business through its Phadia division. Sciex, however, is similarly positioned given the immunoassay business of its Danaher stablemate Beckman Coulter, and the Barclays note suggested that Sciex parent company Danaher "is the only other company that has sufficient scale in both mass spectrometry and in the healthcare/diagnostic channel to develop a seamless clinical mass spectrometry system," though the analysts added that they believe Thermo Fisher has a "significant head start in the clinical mass spec market."
Danaher did hit a notable milestone in its clinical mass spec business this week, however, receiving US Food and Drug Administration clearance for a mass spec-based Vitamin D assay, making it the first and currently only FDA-cleared mass spec Vitamin D assay on the market.
Beyond competition among mass spec vendors, there is also the question of how large in vitro diagnostic companies like Roche and Abbott will respond to Thermo Fisher's planned launch.
In an interview earlier this year, SISCAPA Assay Technologies CEO Leigh Anderson, a clinical mass spec expert and close observer of the industry, said that "evidence continues to grow that at least one major IVD company is building a [mass spec]," that could compete with a walkaway analyzer like Thermo Fisher's. He did not specify what that evidence was, but suggested that such an instrument could present "a major barrier to entry for the MS instrument [vendors]."