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Thermo Fisher Discontinues Cascadion SM Clinical Analyzer


NEW YORK – Thermo Fisher Scientific has discontinued its Cascadion SM Clinical Analyzer, ending one of the more notable forays into clinical mass spectrometry in recent years.

According to Bradley Hart, senior director of clinical research at Thermo Fisher, the company has decided to move away from the fully automated, sample-to-answer model embodied by Cascadion and focus its clinical efforts on less streamlined, but more flexible and more powerful instrumentation.

Hart said the decision to discontinue the product was made last year, at which time the company began informing its customers.

Thermo Fisher introduced the Cascadion in 2017 and began selling it in Europe in 2018. A US launch followed in 2020. The instrument was notable for packaging mass spec technology in a system featuring the automation, robustness, and ease of use of a conventional immunoassay-based clinical analyzer. Thermo Fisher expected the instrument would allow clinical labs to run mass spec-based assays without requiring staff specially trained on mass spec, making LC-MS/MS more broadly accessible.

Mass spectrometry is widely used in clinical labs for a variety of applications, but clinical mass spec instrumentation remains highly complex, often requiring Ph.D.-level scientists to oversee operations. Additionally, many tests run on mass spectrometers are laboratory-developed tests, with a limited roster of in vitro diagnostics available. Mass spec proponents have long held that these factors have limited clinical uptake of the technology despite its superior analytical performance and the cost savings it could potentially offer.

Hart suggested, though, that in simplifying mass spec instrumentation sufficiently to make for a fully automated, walkaway system, Thermo Fisher had eliminated some of the power and flexibility that are key to the technology's appeal.

"Clinical markets like to have automated analyzers, but you have to think about what value mass spec brings to this industry," he said, noting that in addition to strong analytical performance, the ability to quickly add tests for new analytes was a major advantage of mass spec.

"When you build an automated analyzer, you start to constrain some of mass spec's value," Hart said. "We evaluated Cascadion, and the decision was made to discontinue it based on the overall feedback we were hearing from the [lab] industry."

Interestingly, around the time Thermo Fisher introduced the Cascadion, its competitor in the life science mass spec space, Sciex, launched a clinical mass spec instrument that aimed for a different balance of simplicity, flexibility, and power. Called the Topaz, the system was essentially a simplified version of its existing 4500MD LC-MS instrument with a sample prep module and analysis software designed for clinical use. It was more streamlined than a typical research-use mass spec, but far less automated than a traditional clinical analyzer. Sciex offered US Food and Drug Administration-cleared assays for the system, but, unlike Cascadion, users could also develop their own tests on it.

Despite this different approach to the clinical market, the Topaz also found little commercial success, and Sciex discontinued the system in 2020, the same year Thermo Fisher launched Cascadion in the US.

In an interview following Sciex's decision to discontinue the Topaz, James Ritchie, the former director of the core laboratory at Emory Crawford Long Hospital and an early-access user of the instrument, noted that the complexity of the system had made it difficult for Sciex to sell it into primary core labs. He added that Beckman Coulter, one of Sciex's Danaher stablemates, had undercut the Topaz by selling Sciex's traditional clinical mass spec instruments to labs as part of equipment deals, and that the decline of the pain drug testing market had "flooded" the market with used mass spec instruments that created further difficulties for the Topaz.

Ultimately, neither Sciex nor Thermo Fisher were able to find the optimal balance between automation and ease of use on the one hand and power, flexibility, and test menu size on the other.

Joe El-Khoury, assistant professor of laboratory medicine and director of clinical chemistry, laboratory medicine at Yale School of Medicine, had looked into purchasing a Topaz prior to its demise and, more recently, a Cascadion for his facility. Regarding Cascadion, he said the system's limited menu, which in the US consisted solely of an assay to vitamin D (in the EU vitamin D and an immunosuppressant panel were available), was the deal breaker.

"We were interested in buying it," he said. "We looked at quotes from them multiple times. But with [Cascadion] you were restricted to [a limited menu] that you were paying a very high fee for, and it simply didn't make business sense for us to do it."

El-Khoury added that Vitamin D, which both Sciex and Thermo Fisher chose as the lead assays for their systems, turned out to be a poor choice of analyte due to improvements in competing immunoassays.

"Now, I'm comparing the high cost of getting [Cascadion] to an immunoassay running on a line that I already have," he said.

Even so, El-Khoury said he would have seriously considered purchasing a Cascadion had Thermo Fisher managed to get its planned immunosuppressant panel up and running on the system.

While Vitamin D testing isn't typically an urgent matter, labs doing immunosuppressant testing for managing transplant patients, for instance, must have those assays available around the clock. El-Khoury noted that for his lab this means keeping specialized mass spec staff working during weekends.

Had immunosuppressant tests been available on Cascadion, "I could have put [the platform] in my automated chemistry lab and shut down my specialized chemistry lab for the weekend," he said. "That would have saved me shifts and would have made much more sense as a business plan."

Even in the case of immunosuppressant testing, Cascadion faced potential headwinds, however. El-Khoury noted that while immunoassays for immunosuppressants have traditionally performed poorly, they have improved in recent years. In fact, he said that his lab had recently moved its assay for the immunosuppressant tacrolimus, which comprises the majority of immunosuppressant testing, from mass spectrometry to a Roche immunoassay.

"Now, on mass spec we are only running sirolimus and cyclosporin A [for immunosuppressant testing], which are not major volumes," El-Khoury said. "That's the big change that has happened in the last year. So maybe [Thermo Fisher] realized that market had gotten a lot smaller, and it wasn't really worth it."

Leigh Anderson, CEO of clinical proteomics firm SISCAPA Assay Technologies, suggested that looming competition from lab giant Roche might also have factored into Thermo Fisher's decision. The Swiss firm intends to bring a fully automated mass spec clinical analyzer to market in the EU in 2024 with launches in the US and China to follow. Roche first announced its plans for the system in 2017.

"What they did was communicate to Thermo and Sciex that the instant they got any traction, Roche had this ready to roll out and crush them," Anderson said.

Thermo Fisher's Hart said the company's clinical mass spec strategy going forward will prioritize open, more flexible systems capable of measuring a wide range of analytes and quickly bringing aboard tests for new molecules. The company currently has two triple quadrupole instruments, its Quantis MD and Altis MD, registered as clinical devices. It has not yet registered any of its Orbitrap instruments as clinical devices, but Hart said the company sees a role for these systems and that their move into the clinic is "not a matter of if, but when."

While mass spec has largely been a tool for small molecule analysis in clinical applications like toxicology, immunosuppressant testing, and newborn screening, Hart said Thermo Fisher sees a growing role for the technology and its instruments in protein-based testing. He cited the recent acquisition of The Binding Site Group and its diagnostics for blood cancers and immune system disorders as an area where the company's mass spec portfolio could prove effective. He also highlighted outside customers in the protein diagnostics space including Alzheimer's testing firm C2N and infectious disease diagnostics firm NanoPin.