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FDA Rule on Laboratory-Developed Tests Could Shake up Clinical Mass Spectrometry Space


NEW YORK – Among the broad swaths of the lab business affected by the US Food and Drug Administration's recently issued rule on laboratory-developed tests (LDTs), clinical mass spectrometry could be particularly impacted.

Given that a large proportion of clinical mass spec-based tests are laboratory developed, the FDA rule could lead instrument vendors to rethink their commercial strategies or product mix. It could also provide a tailwind for Roche's forthcoming launch of its Cobas i601 mass spectrometry instrument, which will offer FDA-cleared in vitro diagnostic versions of certain commonly run mass spec tests.

The FDA rule "is a threat to all the big mass spec vendors," said Ravinder Singh, director of the Mayo Clinic Endocrine Laboratory, where he has implemented a variety of mass spec-based clinical tests. He predicted that many clinical labs that were planning to buy new mass spectrometers will reconsider that decision in the wake of the FDA rule.

This will likely benefit Roche, Singh added, suggesting that its Cobas i601 system will appeal particularly to smaller hospitals and labs that want to use mass spectrometry but don't have the expertise or desire to take LTDs through the new FDA requirements. Simplicity and ease of use have always been the major selling points of the Roche instrument, which will function as an end-to-end clinical analyzer integrated into the company's larger Cobas Pro system. The FDA rule further heightens that value proposition.

"I think that certainly [FDA oversight of LDTs] is going to make that instrument more attractive," said Joe El-Khoury, assistant professor of laboratory medicine and director of clinical chemistry and laboratory medicine at Yale School of Medicine.

He said that because the Roche instrument will launch with a limited assay catalog, major academic centers like Yale will still continue to run and develop mass spec-based LDTs, even if they move to the Roche system for certain tests, as El-Khoury said his lab will likely do. The impact of the FDA rule will likely have the most significant impact on decision-making at smaller labs and labs that have not yet invested heavily in mass spec, he noted.

"The real attractiveness of the [Roche] system may be more for sites that were thinking of doing mass spec but that, with the FDA rule, may pull back, and this now looks like a more attractive option," El-Khoury said. "For smaller hospitals that don't have anyone with mass spec experience … it is going to be an opportunity to jump in with an automated system and not have to invest in personnel" to perform an LDT.

During Roche's recent investor day, Benjamin Lilienfeld, the company's lifecycle leader for serum work area systems, fielded questions about how the FDA rule might affect the Cobas i601's commercial prospects but did not address the matter directly.

"We've always been … looking at the mass spectrometry market in a way that we want to bring it and advance it from an LDT market to an IVD market," he said. "And we believe that … we can really advance these labs now to a higher standard in terms of mass spectrometry testing." 

Roche plans to launch the Cobas i601 this year in markets that accept the CE mark and in the US in 2025. The company has said it aims by 2031 to capture a 25 percent share of what it calculates to be a CHF 3 billion ($3.39 billion) market.

Roche's entry into the clinical mass spec market follows previous attempts by Sciex and Thermo Fisher Scientific to market instruments specifically for clinical use.

Sciex launched its system, called the Topaz system, in 2017. The instrument was a simplified version of the company's existing 4500MD LC-MS instrument with a sample prep module and analysis software designed for clinical use. It could run both FDA-cleared assays developed by Sciex and laboratory-developed tests. While it was easier to use than a typical research-use mass spec, it was still far less automated than a traditional clinical analyzer and required substantial expertise. This proved an unsatisfying middle ground, and Sciex discontinued the Topaz in 2020.

Thermo Fisher's Cascadion SM Clinical Analyzer, on the other hand, was a sample-to-answer instrument similar to the Roche Cobas i601 and featured the automation, robustness, and ease of use of a conventional chemistry or immunochemistry analyzer. The company was never able to get commercial traction for the system, however, in part due to a limited test menu, which in the US consisted solely of an assay to vitamin D. It discontinued sales in 2022.

Roche plans to launch the Cobas i601 with a test menu that includes a steroid panel, vitamin D testing, immunosuppressant drug testing, and therapeutic drug monitoring tests. Subsequent tests will include assays for vitamin D subclasses, therapeutic drug monitoring, and drugs of abuse.

Meanwhile, other mass spec vendors may need to rethink their approaches to the clinical markets. Singh said that he believes Thermo Fisher undertook development of the Cascadion with an eye toward the possibility of the FDA taking over regulation of LDTs, but having failed in that effort, it is unclear whether the company will try a similar approach again. Thermo Fisher declined a request for comment.

Waters has long played in the clinical market and last year launched a new instrument, the Xevo TQ Absolute IVD Mass Spectrometer, aimed at that space. This year, it launched a pair of reagent kits for clinical labs developing LDTs for measuring steroid hormones. The company has also prioritized growing its clinical business in recent years. At this year's JP Morgan Healthcare Conference in January, Waters President and CEO Udit Batra said that its clinical business had gone from low-single-digit growth from 2017 to 2019 to double-digit growth in 2021 to 2023 and noted that it expects high single-digit growth in coming years. The company declined a request for comment on its clinical strategy following the FDA rule.

Sciex, which also sells mass specs to clinical customers, was likewise not able to provide comments on its future plans by press time.

Vendors may be waiting to see how the FDA rule ultimately shakes out before making any changes in strategy, suggested Jeremy Smith, market manager for forensics and clinical at Shimadzu, which also has a clinical mass spec business.

Smith said that he expects the company will begin discussions in coming weeks about the FDA rule's potential impact on its clinical business, but added that Shimadzu and other mass spec vendors are currently at a "wait and see kind of point."

"I think all the mass spec vendors out there, all the big names … kind of have to play this out a little bit," he said. "As of right now, we are proceeding with business as usual. There are no big changes for us right now in the works."

Smith said he does see the FDA rule potentially benefiting the new Roche system.

"Having FDA clearance on a device like that certainly gives them a leg up because they can say, hey, we have all the compliance necessary, use this for your test, done and done," he said. "From a competition perspective, it can make us think, well, 'Do we want to start working in this direction or don't we?'"

While Roche's large installed base and extensive experience in clinical instrumentation and in vitro diagnostics might deter some potential competitors from developing similar FDA-cleared clinical mass spec systems, it could actually spur additional vendors to tackle the market, suggested Leigh Anderson, CEO of clinical proteomics firm SISCAPA Assay Technologies.

He said that his first impression following Roche's introduction of the Cobas i601 was that it would be the "nail in the coffin" for competing vendors' clinical efforts, but his conversations with several vendors made him reconsider.

"This proves that there is a market, and if Roche has 25 percent of the market globally, the other 75 percent is available," Anderson said. "It has actually encouraged them."

"The issue is, who has the capital and the ambition to compete with Roche?" he said, noting that potential competitors need to develop an automated mass spec instrument with integrated sample processing, "which is no joke."