This story has been updated to include comments from an early access user.
NEW YORK (360Dx) – Sciex announced the launch today of its Topaz LC-MS system, as the company takes aim at the clinical mass spectrometry market.
Based on Sciex's existing 4500MD LC-MS system, the platform is a simplified and streamlined instrument targeting hospital labs and other facilities that are interested in using mass spec for clinical assays but that don't necessarily have the resources and expertise the technology has traditionally required.
The company has also released the first US Food and Drug Administration-cleared assay for use on the instrument, its Vitamin D 200M Assay. The company received de novo FDA clearance in May for the assay, which measures levels of vitamin D2 and D3 while also separating out the D3 epimer.
The Topaz is a notable step in making mass spectrometry a more accessible clinical tool, said Aaron Hudson, senior director and GM of Sciex Diagnostics. The clinical market is a major target for many mass spec vendors, but to date the technology has made limited inroads in large part due to the complexity of mass spec assays and instrumentation and the expertise required to run them successfully.
"If you put yourself in a position of a lab that doesn't have mass spec, our feedback suggests that it's quite a daunting task to bring in mass spectrometry and set up your own methods and then try and get reimbursement [for tests]," Hudson said. "However, many [clinical labs] do want to move towards mass spectometry. So there's this barrier."
"Our strategy is, well, now you kind of have it with training wheels," he added. "You can get a Class I mass spec medical device in your lab. You can put the Vitamin D assay on there, which is cleared by the FDA, so there are fewer worries around validation and that sort of thing. And so it's a much shorter time frame for you to start getting reimbursed and to get a better, faster return on the investment in the mass spec system."
According to Sciex, the Office of Inspector General has reported Vitamin D as one of the top five laboratory assays reimbursed by Medicare, accounting for some 8.7 million laboratory tests and $337 million in reimbursement payments. Vitamin D testing is an area of significant interest within clinical mass spectrometry as some clinicians hope the technology can improve on the performance of existing immunoassays.
Hudson said Sciex views hospital labs as the first target market for the Topaz. The instrument's simplicity will allow these labs to run it using existing personnel without the need to hire a mass spec expert, he said. "It gives much more flexibility in the level of staff that can run the instrument."
Much of this improved ease of use revolves around the system's ClearCore MD software, which Hudson noted offers a simplified interface for setting up and running assays as well as reviewing and delivering results.
Hudson said the company also views the system as having potential to move into clinical labs that are already running Vitamin D and other assays on mass spec but that would like a more streamlined solution.
As it begins selling the system, the most obvious competitor will be Thermo Fisher Scientific's Cascadion SM Clinical Analyzer, which is similarly designed to let clinical labs run mass spec-based assays without needing specially trained staff. Thermo Fisher is currently developing assays for use on the Cascadion for testing Vitamin D, testosterone, and immunosuppressant drug monitoring and has targeted for future assay development monitoring of therapeutics, testing for drugs of abuse, and various endocrinology assays.
The Cascadion arguably goes further than the Topaz in packaging mass spec as a clinical instrument, with a design that is modeled after conventional immunoassay-based clinical analyzers and removes users from any direct interaction with the system's chromatography or mass spec components.
Additionally, unlike the Topaz, the Cascadion is not designed for batch assays but for running samples one at a time, as is done with conventional clinical analyzers. This could make it a better fit with existing clinical lab workflows.
Hudson suggested, though, that Sciex sees the system's similarity to a traditional mass spec instrument as an advantage.
"This is a very traditional LCMS system," he said. "It's in thousands of labs around the world already in slightly different formats. If you want to train your team on LC-MS, then this is an LC-MS platform. It's simplified, but you're able to train your team on it, and they can give the new people coming through their clinical chemistry lab a really good understanding of what LC-MS is."
He said the company considered the ability of users to develop their own assays on the instrument important, as well.
"Rather than being fully locked down, it's a closed system if you want to run Vitamin D, but open if you want to develop your own [laboratory-developed tests]," he said. "In our mind, it's important for labs to be able to do that."
The Cascadion, by contrast, is an entirely closed system that does not allow labs to develop their own assays for use on the platform.
James Ritchie, professor of pathology and laboratory medicine at Emory University and director of the core laboratory at Emory Crawford Long Hospital, suggested that the extent to which potential buyers will be interested in developing their own assays remains "the big question."
"If you have a large enough volume of whatever you are doing and the method is stable you would probably go with the Cascadion," he said, noting that despite Sciex's streamlining, the Topaz still "requires a little more technical involvement."
Ritchie and his group have had the Topaz in their lab for around six months, he said. He has also been participated in an advisory group that worked on the Cascadion, though he has not had a chance to access that instrument as of yet.
He suggested that in his own lab he could see the potential value of both platforms. On the one hand, given his lab's high-throughput "a standalone, hands-free instrument [like the Cascadion] where the tech doesn't do anything would be a real plus," he said. At the same time, "we also do a lot of [laboratory-developed test] assay development, and we want to preserve the ability to do that," he added.
Ultimately, with both instruments going after essentially the same markets, "a lot of it will be personal choice," on the part of buyers, Ritchie said.
And more competition is on the way. At the American Association for Clinical Chemistry annual meeting this week, Roche announced it is partnering with Hitachi to build a mass spec-based clinical analyzer.
One area where the Sciex instrument will, at least initially, have an advantage, is availability. The Roche instrument is still in its early stages and Thermo Fisher has not received regulatory approval for the Cascadion system or any associated assays. The company said it anticipates receiving CE-IVD marking in 2018, which will allow it to sell the device in the EU, and that it expects FDA 510(k) clearance will come sometime after that.
Sciex's Topaz and Vitamin D assay, by contrast, are already FDA-cleared and will be available in the fourth quarter of this year.