| Roche Diagnostics plans to launch a product based onFully Automatic Clinical Analyzer for Mass SpectrometryLaunch into the market.This Swiss life sciences giant plans to firstEURelease the system, and then inThe United States and ChinaLaunch. Benjamin Lilienfeld, Lifecycle Leader of Roche Serum Workspace System, stated that the instrument will be integrated into the company's existing...Cobas Pro Integrated SolutionsAnalyzer, this is a clinical chemistry and immunochemistry analyzer for medium to high throughput laboratories. 
Through this release,Roche Aims to Enter the Clinical Mass Spectrometry Market, this market has proven to be a tough target for suppliers selling more streamlined, automated instruments.Mass spectrometry offers higher sensitivity and specificity than immunoassays. For molecules such as vitamin D and certain hormones, antibody-based tests may struggle to differentiate between closely related forms, allowing for more accurate testing. In light of this potential advantage, researchers and clinicians have been exploring its use for many years.Explore the use of mass spectrometry for such testing。However, mass spectrometry is much more complex than traditional immunoassays, which means that in practice, such assays are still limited to large clinical reference laboratories and specialized testing companies with the resources and trained personnel needed to develop and run these workflows.In recent years, the two major mass spectrometry companiesSciex and Thermo Fisher ScientificAttempts to gain commercial appeal in the form of simplified clinical mass spectrometry instruments accessible to non-professional users have all ended in failure.The Topaz system, launched by Sciex in 2017, is a streamlined version of its existing 4500MD LC-MS instrument, featuring a sample preparation module and analysis software specifically designed for clinical use. The system can run FDA-approved assays developed by Sciex as well as laboratory-developed tests. This instrument is easier to use than a typical research mass spectrometer, but its level of automation is still far lower than that of traditional clinical analyzers, placing it in an unstable middle ground. Sciex discontinued it in 2020.On the other hand, Thermo Fisher's Cascadion SM clinical analyzer is designed as a sample-to-answer instrument, offering the automation, robustness, and ease of use of traditional chemistry or immunochemistry analyzers. However, potential users have been cautious about the instrument's high price, large footprint, and, perhaps most importantly, its limited assay menu. As a result, Thermo Fisher decided last yearStop using this system。The planned Roche instrument, like the Cascadion, is a fully automated sample-to-result system designed to replicate the user experience of traditional clinical analyzers. At its core will be a machine byTriple Quadrupole Instruments Produced by Hitachi, the company manufactures several clinical analyzers for Roche."It's sample preparation, separation by HPLC, and then measurement by LC-MS," Lilienfeld said. "Then it doesn't just give you some data points. The integrated intelligent software provides you with a fully integrated result. It really is inject the sample, get the result. This is what is primarily used in various laboratories today."Although the experiences of Sciex and Thermo Fisher are not good omens for Roche's entry into the clinical mass spectrometry field, there are reasons to believe that the company can achieve greater success.Roche plans to package the instrument as a component of its Cobas Pro system., a fact that will help labs integrate it into existing workflows."You can use it for statistical sampling, you can use it as a standalone instrument, you can combine it with clinical chemistry or even immunochemistry, and you can connect it to a full laboratory automation [system]," Lilienfeld said, notingThis level of connectivity will be crucial for the system's practicality.。"One of the biggest advantages, we believe, isFully Integrated into Clinical Chemistry and Immunochemistry," he said. He cited the example of drug abuse testing, where immunoassays are commonly used for the preliminary screening of positive samples, followed by confirmation testing based on mass spectrometry.The integration of mass spectrometers with the Cobas Pro chemistry and immunochemistry analyzer allows laboratories to establish workflows where positive samples are automatically run on the mass spectrometer to confirm results.Lilienfeld said that Roche expects the system to find a market in both small labs that lack mass spectrometry expertise and want to enter mass spectrometry-based testing, as well as large labs (such as those that already have extensive mass spectrometry infrastructure but may see new instruments as a way) to streamline their operations."Quest, Labcorp, yes, they are doing mass spectrometry, but now they have 20, 25, 30 different analyzers running mass spectrometry, requiring a large amount of highly skilled labor to operate," he said. "When talking with these customers, they are very interested in integrating their numerous research mass spectrometers into a single, standardized, integrated analyzer so that they can operate faster, rely on our IVD tests for quality, and reduce the number of highly skilled labor."Perhaps the biggest flaw in Sciex and Thermo Fisher clinical mass spectrometry work isFailed to quickly establish their test menuIn the United States, neither of the two companies expanded their menu beyond the initial vitamin D assay before discontinuing the use of the instrument. Lilienfeld said Roche plans to offer "Wide Range of Analyte Menus”。He said that the company will initially offer tests for vitamin D, therapeutic drug monitoring, immunosuppressant testing, and drug abuse testing.Joe El-Khoury, Assistant Professor of Laboratory Medicine at Yale School of Medicine and Director of Clinical Chemistry and Laboratory Medicine, considered purchasing the Sciex Topaz and Thermo Fisher Cascadion for his lab but ultimately declined, largely due toDue to the limited test menuHe said that due to a confidentiality agreement with Roche, he was unable to discuss the specifics of Roche's instruments. However, he stated, "Generally speaking, if a clinical and automated mass spectrometer capable of performing various tests becomes available on the market within the next two to three years, we would definitely be interested."El-Khoury said,An automated mass spectrometer with a reliable test menu and sufficient throughput can "revolutionize the way we conduct certain tests."He cited an example from toxicology, saying that the pediatric emergency department at his medical center had recently been dealing with false positives in morphine immunoassays."This has got their attention," he said. "A lot of the [toxicology] immunoassays that we use today could be translated to mass spectrometry because you could get better performance."El-Khoury said that endocrine testing is another area where automated mass spectrometry analyzers could be very useful. "If you can do all of this through mass spectrometry, you wouldn't even touch immunoassays because of all the interferences.""It's clear that some people will keep [immunoassays], but it's open," he said.
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