Executives from several major mass spec vendors presented this week at the JP Morgan Healthcare Conference in San Francisco, offering comments on their company's recent performances and glimpses into their plans moving into 2013.
The presentations reinforced the emerging interest in mass spectrometry as a clinical tool with companies including Bruker, AB Sciex, and Agilent highlighting their efforts in this area.
They also provided insight into the sales performance of several recent high-profile mass spec releases, specifically Thermo Fisher Scientific's Q Exactive instrument and AB Sciex's 4600 and 5600 TripleTOF machines.
Despite various hurdles that remain– including questions of cost, sensitivity, and throughput – mass spec vendors have in recent years demonstrated an interest in moving their instruments into the clinic to perform protein-based tests, and several reiterated this interest this week.
Notably, Bruker CEO Frank Laukien said during his company's presentation that its "clinical and in vitro diagnostic component… is becoming more and more important, and is now beginning … to move the needle with good growth and also with above-average margins."
Bruker has been collaborating with researchers including SISCAPA Assay Technologies CEO Leigh Anderson on MALDI mass spec methods for clinical proteomics. Last January the company and its collaborators published a paper in the Journal of Proteome Research demonstrating the ability of its autoflex speed MALDI-TOF instrument to perform relative quantitation of peptides with coefficients of variation of between 1 and 2 percent, suggesting the platform's clinical potential (PM 1/30/2012).
Laukien also noted that Bruker last year released its first LC-triple quad instruments, the EVOQ Qube and EVOQ Elite (PM 9/7/2012). These additions could likewise prove important to the firm's clinical ambitions, as much clinical proteomics research has focused on the potential of triple quadrupole mass specs as diagnostic platforms.
To date, however, Bruker's primary successes in the clinical proteomics arena have come from its MADLI Biotyper instrument, a mass spec-based system for pathogen detection and clinical microbiology. The company began selling the instrument in Europe in 2006 and, since then, has obtained regulatory clearance for diagnostic applications in Canada, Australia, New Zealand, Taiwan, and Japan and placed more than 700 MALDI Biotypers worldwide "either paid as a lease or as an acquisition," Laukien said.
The company is aiming for US Food and Drug Administration approval of the device in the second half of 2013, he added. It is also pursuing a CE-IVD mark for the device in Europe.
Agilent likewise highlighted its clinical mass spec ambitions this week, with Nick Roelofs, president of the company's Life Sciences group, citing it as a potential growth area.
"There is a real move for analytical equipment in the clinic, and we are trying to pursue that by being an instrument provider," he said. Roelofs added that diagnostics research was pulling LC-MS into the clinic.
"Customers are developing laboratory-developed tests," he said. "There's a lot of that going on in the US, and there's also a lot of that going on in emerging markets where there is no paradigm to displace. And we believe that the mass spectrometer is a fundamental instrument in this space."
Indeed, Agilent is currently collaborating with firms developing LDT protein biomarker tests, most notably through its collaboration with Integrated Diagnostics for its LDT proteomic tests for lung cancer and Alzheimer’s disease (PM 1/13/2012).
Roelofs noted Agilent's move last year to register its Infinity Series 1200 liquid chromatography systems and 6000 Series mass spectrometry systems as Class I medical devices with the US Food and Drug Administration, clearing the way for their use in clinical settings (PM 1/20/2012).
"We believe that will help our customers develop methods and accelerate this transformation [in clinical mass spec] that we're trying to participate in," he said.
Danaher CEO Larry Culp also touched briefly on clinical mass spec during his presentation. "I think over time you'll certainly see more mass specs in the clinic," he said, noting that the company's Beckman Coulter assets could ease the path into the clinic for its mass spectrometers.
Culp also offered some information on sales of AB Sciex's 5600 TripleTOF and 4600 TripleTOF instruments, noting that the introduction of these products had been "very strong" and have "expanded the size of the served markets by about $400 million."
Thermo Fisher Scientific CEO Marc Casper likewise used his company's presentation to provide data on sales of one of the firm's recent high-profile mass spec releases, the Q Exactive.
Since the company launched sales of the device at the end of 2011, "it has built out a well-over-$100 million business … basically taking share in the Q-TOF market," Casper said.
When Thermo Fisher introduced the Q Exactive at the 2011 American Society for Mass Spectrometry annual meeting in June, Ian Jardine, the company's vice president of global R&D, told ProteoMonitor that it was "going directly after the Q-TOF market" (PM 6/10/2011).
Q-TOFs, at that time, represented a roughly $250 million per year market, suggesting that, with more than $100 million in Q Exactive sales over the last year, Thermo Fisher has taken considerable market share from other vendors.
And, indeed, as reported by ProteoMonitor sister publication GenomeWeb Daily News, Waters CEO, president, and chairman Doug Berthiaume said during his company's presentation this week that the company's high-end mass spec platforms were hurt in 2012 by competition from the Q Exactive (GWDN 1/8/2013).
In addition to competing in the Q-TOF market, the Q Exactive has also shown promise as a potential alternative to triple quadrupoles for peptide and protein quantitation, with papers published separately by the labs of University of Wisconsin-Madison researcher Josh Coon and Bruno Domon, head of the Luxembourg Clinical Proteomics Center, demonstrating that the system could compete with triple quads in terms of sensitivity while potentially offering easier targeted assay development and better specificity (PM 10/12/2012).
In his presentation, Casper hinted at significant new mass spec releases in 2013, noting that Thermo Fisher has "great products lined up" for launch at this year's ASMS meeting.
Casper also addressed the clinical mass spec market, noting that the clinical relevance is fast approaching. According to reporting by GWDN, he said that while he doesn't foresee mass specs getting the needed regulatory clearances required for them to move to clinical settings in 2013, it could occur in the relatively near future.