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Roche Planning 2024 Launch of Automated Mass Spec Clinical Analyzer


NEW YORK – Roche Diagnostics plans to bring a fully automated mass spectrometry-based clinical analyzer to market in 2024.

The Swiss life science giant intends to release the system first in the EU followed by launches in the US and China. Benjamin Lilienfeld, lifecycle leader of serum work area systems at Roche, said the instrument will be integrated into the company's existing Cobas Pro Integrated Solutions analyzer, a clinical chemistry and immunochemistry analyzer for mid- to high-throughput laboratories.

With the release, Roche aims to crack a clinical mass spec market that has proven a tough target for vendors marketing more streamlined, automated instrumentation.

Mass spec offers greater sensitivity and specificity than immunoassays, and for molecules like Vitamin D and certain hormones where antibody-based tests can have trouble distinguishing between closely related forms, it can enable more accurate testing. Given this potential advantage, researchers and clinicians have for years explored use of mass spec for these sorts of assays.

However, mass spec is significantly more complicated than conventional immunoassays, which has meant that, in practice, such assays have remained confined to large clinical reference labs and esoteric testing businesses with the resources and trained personnel required to develop and run these workflows.

In recent years, two major mass spec firms, Sciex and Thermo Fisher Scientific, have tried and failed to gain commercial traction for what they marketed as simplified clinical mass spec instruments accessible to nonexpert users.

Sciex's Topaz system, which the company launched in 2017, was a simplified version of its existing 4500MD LC-MS instrument with a sample prep module and analysis software designed for clinical use. The system could run both US Food and Drug Administration-cleared assays developed by Sciex and laboratory-developed tests. Easier to use than a typical research-use mass spec but still far less automated than a traditional clinical analyzer, the instrument occupied an uneasy middle ground, and Sciex discontinued it in 2020.

Thermo Fisher's Cascadion SM Clinical Analyzer, on the other hand, was intended as a sample-to-answer instrument featuring the automation, robustness, and ease of use of a conventional chemistry or immunochemistry analyzer. However, potential users were wary of the instrument's high price, large footprint, and, perhaps most important, limited assay menu, and Thermo Fisher decided last year to discontinue the system.

The planned Roche instrument is, like the Cascadion, a fully automated sample-to-answer system designed to replicate the user experience of a traditional clinical analyzer. At its core will be a triple quadrupole instrument produced by Hitachi, which manufactures several of Roche's clinical analyzers.

"It's preparation of the sample, the separation on HPLC, and then the measurement on the LC-MS," Lilienfeld said. "And then it doesn't just give you some data points. There is intelligent software integrated that will give you a fully integrated result. It's really sample in, results out. And that's the big difference from the mass spectrometry analyzers that are largely in use today in various labs."

While the experiences of Sciex and Thermo Fisher don't bode well for Roche's push into clinical mass spectrometry, there are some reasons to think the company could meet with more success.

The fact that Roche plans to package the instrument as a component within its Cobas Pro system will help labs integrate it into their existing workflows.

"You can do stat samples, you can use it as a standalone instrument, you can combine it with clinical chemistry or even immunochemistry, you can connect it to a total lab automation [system]," Lilienfeld said, noting that this level of connectivity would be key to the system's usefulness.

"We believe one of the biggest advantages is the full integration into clinical chemistry and immunochemistry," he said. He cited the example of drugs-of-abuse testing where initial screening is often done using immunoassays with positive samples then passed on for mass spec-based confirmatory testing.

Integration of the mass spec analyzer with the Cobas Pro chemistry and immunochemistry analyzers could allow labs to set up workflows where positive samples are automatically run on the mass spec analyzer to confirm the result.

Lilienfeld said Roche expects the system will find a market both among smaller labs without mass spec expertise who want to move into mass spec-based testing and larger labs like national laboratories that already have extensive mass spec infrastructure but may see the new instrument as a route to streamlining their operations.

"Quest, Labcorp, yes, they are doing mass spectrometry, but they have 20, 25, 30 different analyzers right now running mass spectrometry, with a huge amount of highly skilled labor that is needed to run it," he said. "Speaking to these customers, they are very much interested in consolidating their numerous research mass spectrometry analyzers onto a single, standardized, integrated analyzer so that they can be faster, they can rely on IVD tests where we are taking responsibility for the quality, and they can reduce the number of highly skilled laborers."

Perhaps the biggest pitfall for Sciex's and Thermo Fisher's clinical mass spec efforts was a failure to quickly build out their assay menus. In the US, neither company grew their menu beyond an initial vitamin D assay before discontinuing their instruments. Lilienfeld said Roche plans to offer "a broad menu of different analytes."

He said the company will initially offer tests for vitamin D, therapeutic drug monitoring, and immunosuppressant testing, with assays for steroids and drugs-of-abuse testing to follow.

Joe El-Khoury, assistant professor of laboratory medicine and director of clinical chemistry, laboratory medicine at Yale School of Medicine, considered purchasing both a Sciex Topaz and Thermo Fisher Cascadion for his lab but ultimately declined, in large part due to the limited assay menus. He said he could not discuss the Roche instrument specifically due to a non-disclosure agreement he has with the company but said that, generally speaking, "if a clinical and automated mass spec analyzer that does a variety of tests becomes available in the next two to three years, we will absolutely be interested."

El-Khoury said that an automated mass spec analyzer with a solid test menu and sufficient throughput could "completely change how we operate with certain tests."

He cited the example of toxicology where he said his medical center's pediatric emergency department has recently been dealing with an issue of false positives on morphine immunoassays.

"It's causing huge concern for them," he said. "With the [toxicology] immunoassays we are using today, a lot of them could be converted to mass spec because of the better performance you get."

Endocrine testing is another area where an automated mass spec analyzer could be highly useful, El-Khoury said. "If you could do all that by mass spec, you wouldn't even touch an immunoassay because of all the interferences."

"Some, obviously, will stay [immunoassays], but it's wide open," he said.