NEW YORK – Following the European launch of its new Cobas I 601 mass spectrometry analyzer in December, Roche is now preparing to release an initial set of tests on the instrument including for steroid hormones, Vitamin D, and immunosuppressant and therapeutic drug monitoring.
The company is also planning a US launch for the system in the second half of this year for running tests including vitamin D and certain steroid assays under CLIA before the tests and system possibly receive US Food and Drug Administration 510(k) clearance, said Benjamin Lilienfeld, lifecycle leader serum work area systems at Roche Diagnostics.
He said the company has also had initial discussions about the instrument with some Asian countries.
Lilienfeld said Roche will roll out the initial set of tests in Europe over the course of 2025. It currently has CE marking for four tests on the system for steroid hormones. In two to three years, it plans to launch another set of tests for the European market that will include additional subclasses of vitamin D, additional tests for therapeutic drug monitoring, and a "fairly big panel" for drugs of abuse testing, he said.
The company plans to launch the same tests in a similar sequence in the US, Lilienfeld said.
The Cobas I 601 analyzer is a fully automated, sample-to-answer clinical analyzer that can be integrated into the company's larger Cobas Pro system. It brings to clinical mass spectrometry the simplicity and ease of use that has long been common to conventional clinical chemistry and immunoanalyzers.
Robert de Jonge, professor and head of clinical chemistry at Amsterdam UMC, said that the Cobas I 601 has allowed his lab to shift its mass spectrometry experts away from routine mass spec testing to focus on things like the development and running of new laboratory-developed tests.
"We are a university hospital, so for us, discovering and making new techniques is a core business, but a lot of our [capacity is used] by tests that were once exciting and new, like vitamin D, but which are now relatively routine but are still operated by specialized techs in specialized environments," he said. "It frees up our capacity to develop new things, to do high-end mass spec."
De Jonge said the instrument could also allow his lab to return results more rapidly for certain tests or to test patients more frequently than was previously feasible.
Currently, he said, many mass spec tests are done in batches, run once or twice per week depending on the volume. The automated nature of the Cobas I 601, along with its ability to do random access testing, means labs can run samples as they come in instead of saving them for batch testing.
"You can have a result for the emergency department in an hour or two hours," de Jonge said.
He said he expects this to be particularly useful for certain kinds of therapeutic drug monitoring where delays in testing can negatively impact patient care. He cited as an example the challenge of monitoring antiepileptic drugs in pregnant women, in whom the levels of these drugs can fluctuate dramatically.
"Because we measure them only two or three times a week, sometimes [doctors] are following blind protocols for dosing or adjusting the dose," he said. "Now we can just measure it and have an exact level and adjust [the dose] accordingly."
Roche is the second company to take a stab at a fully automated mass spec-based clinical analyzer. Thermo Fisher Scientific's Cascadion SM Clinical Analyzer was likewise a sample-to-answer instrument intended to offer the same ease of use as conventional clinical analyzers. The company began selling the system in Europe in 2018 and in the US in 2020 but never managed to get commercial traction. It discontinued the product in 2022.
The Cascadion suffered from a limited test menu, which consisted solely of vitamin D in the US and of vitamin D plus an immunosuppressant panel in Europe. As Joe El-Khoury, assistant professor of laboratory medicine and director of clinical chemistry, laboratory medicine at Yale School of Medicine, told 360Dx following Thermo Fisher's decision to discontinue the system, vitamin D turned out to be a poor lead test for the system due to improvements in competing immunoassays and the fact that it doesn't typically require a quick turnaround time.
El-Khoury said, however, that had Thermo Fisher offered immunosuppressant testing on the Cascadion in the US, he would have seriously considered purchasing the instrument. Labs doing immunosuppressant testing for managing transplant patients, for instance, must have those assays available around the clock, which currently means having specialized mass spec staff available, as well.
De Jonge said that he and his colleagues looked into obtaining a Cascadion for Amsterdam UMC but that they were not able to reach an agreement with Thermo Fisher. He said the instrument's limited test menu was a concern and added that he did not feel the company had generated sufficient data demonstrating the performance of its tests before taking them to market.
Including the tests Roche aims to launch in its second wave of releases, it has assays to 66 analytes planned for the platform.
Looking to the second wave of releases, Lilienfeld said the company expects drugs of abuse testing to be important for driving uptake, especially in the US.
Drugs of abuse testing is a major application of clinical mass spectrometry. According to a recent report by the US Department of Health and Human Services (HHS) Office of Inspector General (OIG), four of the top 25 tests by Medicare spending in 2023 were mass spectrometry-based drug tests, which accounted for a total of $403.9 million in spending.
Roche could also benefit from the FDA's recently instituted rule on laboratory-developed tests (LDTs). A large proportion of clinical mass spec-based tests are LDTs, which are now subject to additional regulatory requirements. While the long-term fate of the rule remains unclear, it could make Roche's offerings of FDA-cleared in vitro diagnostic versions of certain commonly run mass spec tests more compelling.
Lilienfeld said the issue of LDT regulation has been "very much part of the discussions" the company has had with potential US customers.
"Some of them told us, 'You are coming at the right time with this,'" he said. "I think it is fair to say it is not really clear where [LDT regulation] is going, but independently of that, it is a benefit. … [Customers] don't have to worry which way the [LDT] discussions go. They get an FDA-approved assay, they are definitely on the safe side."
Lilienfeld said that while the instrument's integration with the larger Cobas Pro system makes it a straightforward fit for existing Roche customers, the company also sees it as a potential "door opener" to introduce non-Roche customers to its products beyond the Cobas I 601.