NEW YORK (360Dx) – Roche's announcement last week at the American Association of Clinical Chemistry annual meeting that it is developing a mass spectrometry-based clinical analyzer gives the space both meaningful validation and a formidable new competitor.
Speaking to analysts at the AACC meeting, Jean-Claude Gottraux, head of Roche professional Dx said the company plans to develop a mass spec-based system with Hitachi, its collaborator on a number of other clinical instruments.
As reported in a research note issued by Barclays analyst Jack Meehan, Gottraux said the company plans "to take mass spectrometry from the dark corners of the research lab and put [it] into the mainstream, into the main lab."
He added that Roche believes mass spec "is the next frontier," and that the company is planning a launch menu that it will release "in several waves."
Gottraux noted that Roche expects mass specs will likely cannibalize some existing parts of its clinical business, but that "if there is going to be some kind of cannibalization of our portfolio, we prefer to be the ones who do it rather than be on the receiving end."
Roche executives were not available to comment as of press time.
The Roche announcement comes after Thermo Fisher Scientific and Sciex introduced their own clinical mass spec products in recent months, marking the most serious efforts to date by mass spec vendors to position the technology as a competitor to existing clinical platforms like immunoassay-based clinical analyzers.
Sciex last week formally introduced its Topax LC-MS system (after issuing a release in May upon receiving US Food and Drug Administration de novo clearance), a streamlined mass spec platform based on the company's existing 4500MD LC-MS. The company has also released the first FDA-cleared assay for use on the instrument, its Vitamin D 200M Assay. The assay measures levels of vitamin D2 and D3 while also separating out the D3 epimer. Both the platform and the Vitamin D assay will be available in the second half of 2017
Thermo Fisher in June introduced its own clinical mass spec system, the Cascadion SM Clinical Analyzer. Unlike the Topaz, which remains recognizably a mass spec instrument, albeit a simplified one, the Cascadion is designed to look and operate essentially like a conventional clinical analyzer, which could give it an edge over the Topaz, particularly among high-throughput users interested in a turnkey option.
Sciex is developing additional automation for the Topaz in collaboration with its Danaher stablemate Beckman Coulter. The company has also argued that the Topaz's ability to switch between a locked down format for running FDA-cleared assays and an open format for running laboratory-developed tests is a potential selling point for the system.
The extent to which potential buyers will be interested in this sort of LDT capability, versus the more turnkey operation of the Cascadion system, remains "the big question," said James Ritchie, professor of pathology and laboratory medicine at Emory University and director of the core laboratory at Emory Crawford Long Hospital. Ritchie and his group have had the Topaz in their lab for around six months as early access users. He has also participated in an advisory group that worked on the Cascadion.
Assuming it does bring a mass spec-based system to market, Roche will be a serious competitor for the Topaz and Cascadion, Ritchie said, noting that the firm's large clinical presence will give it an advantage. According to the Barclay's report, Roche is by far the largest provider of centralized core lab technologies, with 26 percent of the market. Beckman Coulter is also a major player, with 13 percent of the market.
Ritchie said that Roche will be able to incentivize existing customers to opt for its mass spec via various sales deals.
"If your main core lab is all Roche, it's easy to buy up into another piece of equipment because they will extend your contract another year or two or make some other financial deals once they have their foot in the door," he said. "That counts for something."
A Roche instrument could be made even more attractive if it were built to be compatible with existing lab automation lines, Ritchie said, noting that the Cascadion's standalone nature is "probably its main drawback."
Sciex will have an advantage in terms of being first to market with a launch this year. Thermo Fisher said it plans to launch the Cascadion in Europe next year, but it has not provided a date for a US launch, and it has not received the required regulatory approvals as of yet.
The timeline for the Roche system is even less clear, though SISCAPA Assay Technologies CEO Leigh Anderson, a clinical mass spec researcher and close observer of the industry, said that the company's partner Hitachi has been doing R&D on triple quadrupole instrumentation, the most likely mass spec format to be used in a clinical system.
Anderson said in February that he had knowledge of a major life science company that was developing a mass spec-based clinical analyzer to compete with potential offerings from mass spec vendors like Thermo Fisher and Sciex, though he did not name Roche at that time.
"It sounds like Thermo decided to put a stake in the ground [in response to Sciex's Topaz launch], and it sounds like Roche has decided to put a stake in the ground at the same time to dissuade as many customers as possibly from defecting from a pure Roche platform," Anderson said. "Bottom line, it is tremendous validation for the idea [of mass spec as a clinical technology], and that is good for the space in many ways."