Several major mass spec vendors took the stage this week at the JP Morgan Healthcare Conference in San Francisco, highlighting strong sales of recent instrument launches and sketching out potential future directions for their businesses.
A number of presentations touched on the continuing rise of clinical mass spec, with Danaher, Agilent, and Bruker discussing efforts to move various systems into the clinic.
Danaher President and CEO Larry Culp, for instance, reiterated that company's plans to obtain US Food and Drug Administration for its mass spectrometers, which are housed in its AB Sciex business. AB Sciex made significant headway in this respect in 2013, releasing its 3200MD and 3200MD QTRAP instruments as FDA Class I exempt medical devices, making them available for clinical use.
In May, these devices received the EU CE-IVD mark, which allowed them to be sold in the EU for general in vitro diagnostic use including in hospitals and clinical diagnostic laboratories.
AB Sciex also last year formalized a collaboration with its Danaher stablemate Beckman Coulter to develop that company's Biomek lab automation platform for use in sample prep for clinical mass spec assays.
Agilent CEO Bill Sullivan likewise addressed his company's clinical ambitions. Noting that its 2012 purchase of molecular diagnostics firm Dako provided the firm with assets that would help it navigate the clinical diagnostics regulatory environment, Sullivan observed that, parallel to the development of genomic tests, "mass spectrometers are [also] moving into the clinic."
He added that, in particular, mass spec was proving useful as part of laboratory-developed tests. And, indeed, Agilent has over the last several years focused on positioning its platforms for use in proteomic LDTs, collaborating with researchers like SISCAPA Assay Technologies' Leigh Anderson and diagnostic firms like Sera Prognostics, Applied Proteomics, and Integrated Diagnostics on platforms and workflows for mass spec-based proteomic diagnostics.
In October, this effort bore its first fruit – in terms of actual clinical implantation, at least – as Indi launched a proteomic LDT for lung cancer using an Agilent 6490 triple quad and based, in part, on workflows developed through the two companies' collaboration.
With its MALDI Biotyper instrument, Bruker has arguably enjoyed the most success of any mass spec vendor in terms of clinical proteomics. In its presentation this week, the company noted that it has to date placed more than 1,000 of the devices, which use proteomic analyses to make microbial identifications.
This year, the instrument received US FDA 510(k) clearance, as did its primary competitor in the proteomic microbial ID space, BioMérieux's Vitek MS system.
Bruker also this week highlighted its plans to develop MALDI-TOF mass spec as a platform for clinical validation of protein biomarkers and proteomic IVDs. This sets the company apart from its competitors, which, by and large, have focused on establishing triple quad-based workflows as standard for clinical proteomics.
While triple quads have traditionally offered better performance in terms of sensitivity and reproducibility, recent research has suggested that MALDI systems could close that gap. MALDI also offers potential advantages in terms of throughput and workflow simplicity.
In addition to discussing clinical proteomics, several vendors also took a moment to highlight the strong sales of certain recently launched instruments. Waters President and CEO Douglas Berthiaume, for instance, cited his firm's Q-TOF and Synapt mass specs, noting that their sales grew in the double digits in 2013.
Danaher's Culp, meanwhile, singled out AB Sciex's 6500 instrument as a top performer. Launched at the American Society for Mass Spectrometry's 2012 meeting, the instrument has hit $100 million in sales, he said.
And, Thermo Fisher Scientific CEO Marc Casper said that he expected that the company's Orbitrap Fusion Hybrid mass spec would likewise prove a "$100 million product." The instrument, which sells for roughly $800,000 and combines a quadrupole, ion trap, and Orbitrap in a single device, will prove "a revolutionary product in terms of applications at the high end of proteomic research," Casper said.
He said, as well, that high end mass specs were among the company's fastest growing products in 2013, and asserted that it had taken "substantial market" share from its mass spec competitors.
Casper also discussed Thermo Fisher's impending acquisition of Life Technologies, noting that the company saw great potential for Life Tech's Ion Torrent next-generation sequencing platform. Agilent and Danaher also discussed NGS during their presentations, with both firms identifying sequencing as a gap in their portfolios that they could in the future take steps to fill.
Clearly, such vendor interest in NGS is primarily important with regard to their genomics businesses. However, NGS could play an interesting role in proteomic research, as well.
For instance, a number of firms and researchers have explored NGS as a read-out platform for proteomic experiments conducted using reagents like DNA-linked antibodies and aptamers. And, in fact, prior to being acquired by Thermo Fisher, Life Tech announced that it was developing its Ion Torrent technology for protein analysis.
Perhaps more interesting is the role of NGS in building sample-specific reference databases for mass spec-based proteomics. Use of such databases, which are typically generated via RNA-seq, has become more widespread as proteomic researchers grow increasingly interested in analyzing protein variants specific to particular cell lines, tissues, or individuals.
Indeed, several researchers have suggested to ProteoMonitor in recent months that use of sample-specific databases will in the future become standard proteomics practice. This, in turn, could increase demand for streamlined NGS-mass spec workflows that will allow researchers to more easily generate and use such databases.
Currently, Thermo Fisher is the only firm that could theoretically put together such an offering. Agilent and Danaher's comments this week suggest, however, that this may not remain the case.