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Roche Updates Mass Spec Launch, Instrument Upgrades, Upcoming Tests at Investor Day

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NEW YORK – At its investor presentation in London on Wednesday, Roche Diagnostics executives described the company's pipeline plans, which include a variety of new tests, instrument upgrades, and the upcoming launch of its long-awaited fully automated mass spectrometry instrument. 

The presentations covered the whole of Roche's diagnostics business, including point-of-care testing, core laboratory, molecular testing, pathology, and its sequencing efforts, including a nanopore sequencer that is in development. 

Roche Diagnostics CEO Matt Sause highlighted four key disease areas for the company: cardiometabolic, oncology, infectious disease, and neurology, all of which have active pipelines. He added that the firm expects to launch approximately 125 tests in the next three years. 

Palani Kumaresan, the global head of Roche Diagnostics solutions, added that the firm plans to launch about 40 tests each year. The cardiometabolic pipeline is focused on heart failure, coronary artery disease, chronic kidney disease, and diabetes, he noted. The company is developing additional assays with existing and new biomarkers — particularly for the diagnosis of myocardial infarction — and is launching a new point-of-care immunochemistry instrument, the Cobas Sense, which is intended for cardiovascular testing in the emergency department. The platform will have tests for "critical cardiac markers" and lab-like performance, Kumaresan noted. 

The Cobas Sense will provide results in 12 minutes and have the same cutoffs as the Elecsys instrument. A high-sensitivity troponin test is first on the docket, but the firm plans to broaden its menu with tests for NT-proBNP and d-dimer, added Ildikó Amann-Zalán, head of R&D for Roche Diagnostic Solutions. The market potential is CHF 1 billion ($1.1 billion), a "sizable market we'd definitely like to serve," she said. 

The company's neurology pipeline has been an active area of focus for the company and ties in with Roche Pharmaceuticals' development efforts for new drugs for Alzheimer's and other neurodegenerative disorders. Roche Diagnostics has multiple blood-based Alzheimer's tests in development that have breakthrough device designation from the US Food and Drug Administration, including its Elecsys Amyloid Plasma Panel and its pTau217 test. Roche expects to file for regulatory approval for the Amyloid Plasma Panel in 2025 and for the pTau217 test in 2026. 

It also has a test for neurofilament light chain that can be applied to multiple sclerosis patients and may be of use for patients with other neurological disorders, Kumaresan said. The company is also continuing its early research into Parkinson's disease and developing a panel for traumatic brain injuries. 

For infectious diseases, Roche Diagnostics is continuing to "focus on the big indications like hepatitis, HIV, and upper respiratory infections," Kumaresan said. He also emphasized the development of an Elecsys interferon-gamma release assay (IGRA) for latent tuberculosis. 

The latent tuberculosis test was the subject of much interest among investors, and Sause noted that Roche's IGRA test for SARS-CoV-2 acted as a "proof of principle" for the technology. Kumaresan said that the test's development hinges on the need to have the right stimulating peptides targeting tuberculosis, and the firm has partnered with an undisclosed company for the peptides.

Sause noted that there is a large market for latent tuberculosis testing and that Roche will be entering that market with an automated test and a large global installed base of Elecsys instruments that can utilize the test. "Labs always are looking to consolidate their tests on the same platform, so if we can bring that test into an existing platform the lab has, that's an important advantage," Kumaresan added. 

Amann-Zalán also noted that the firm has submitted a four-plex respiratory infection panel to the FDA for Emergency Use Authorization that would detect influenza A/B, SARS-CoV-2, and respiratory syncytial virus on the Cobas Liat platform. 

Roche is working on additional tests for sepsis, vector-borne diseases, and sexually transmitted infections, Kumaresan noted, including a collaboration with Prenosis to investigate the use of machine learning with biomarkers and clinical vital signs to improve the diagnosis of sepsis. 

The oncology business encompasses multiple modalities, including immunohistochemistry, molecular testing, sequencing, and immunoassays, and has solutions across the cancer spectrum, including for screening with its recent FDA clearance of a device for HPV self-collection, diagnosis with its IHC/ISH applications, therapy selection and risk stratification with the Foundation Medicine companion diagnostic tests, and monitoring with the Foundation Monitor test, among others. 

Core lab efforts 

A key area of focus for the company on Wednesday was its serum-based tests and systems, which encompasses most of its clinical laboratory platforms. Benjamin Lilienfeld, the company's lifecycle leader for serum work area systems, noted that the firm's installed base grew significantly across multiple instruments, including the Cobas Pro and Cobas Pure integrated solutions, the point-of-care Cobas Liat platform, and the molecular Cobas 5800, 6800, and 8800 instruments. 

For high-volume clinical laboratories, Roche plans to launch the Cobas ISE Neo and Cobas c703 units in countries accepting CE-IVD marking in mid-2024 and in the US in 2025. The new units will double the throughput on the Cobas Pro solution, with the c703 instrument allowing users to run 2,000 tests per hour and minimizing the hands-on time for maintenance. Lilienfeld said that the c703 will help address the "severe shortage of qualified lab staff we see all around the world." The company's goal is to transition its customers to the latest fully standardized instrument generation over the next few years, which will help protect and expand its installed base in the field. 

Mass spec peek 

The most newsworthy reveal of the presentation, however, was the official unveiling of Roche's Cobas i601 mass spectrometry instrument. The platform, which has been under development for more than 10 years, will allow Roche to "tap into a completely new business segment," Lilienfeld said. It is "not just another mass spec solution" and will be able to fully integrate into the firm's existing Cobas Pro solution and a laboratory's clinical chemistry and immunochemistry testing. 

The entire testing process is automated, encompassing sample input, sample preparation, sample separation on liquid chromatography, mass spectrometry, and result interpretation. The platform is standardized and fully IVD compliant, Lilienfeld said, including the ready-to-use reagent packs containing the mass spectrometry analytes. It also includes standard buffers that will be mixed according to the needs of various analytes, as well as proprietary liquid chromatography cartridges. 

"Today, one of the most time-consuming and critical points is the exchange of the liquid chromatography columns," but the new instrument "will bring down a complex process that takes sometimes more than an hour to literally 20 to 30 seconds," Lilienfeld said. 

The instrument will be launched with a broad assay menu that will come in two waves over the next multiple years under the reagent brand Ionify. The first wave will include a steroid panel, Vitamin D testing, immunosuppressant drug testing, and therapeutic drug monitoring tests, while the second wave will add additional Vitamin D subclasses and therapeutic drug monitoring analytes, as well as a drugs-of-abuse panel. Lilienfeld added that there are "plenty of opportunities for more and additional assays," as well. 

The firm is "bringing … something completely new to market" and wanted to focus on high-volume parameters that are currently run in mass spectrometry laboratories, he said. However, the company has a list "with literally hundreds of candidates for the future." Because the instrument is a liquid chromatography triple-quant mass spectrometer, it is best for peptides. Larger proteins may be challenging to detect, but anything that is small is "perfectly suitable for this instrument." 

Kumaresan noted that there may be a possibility of "post-translational modifications" in the future and that he believes the platform is a "generational technology … that we can continue to drive forward in the coming years." 

The Cobas i601 will launch at the end of 2024 in markets that accept CE marking and next year in the US and will help Roche address a CHF 3 billion sales market, he said, adding the company intends to reach a 25 percent market share by 2031. 

The new platform will "advance mass spec from specialized testing to routine testing discipline," Lilienfeld said. "The difference is you don't need to be a specialist anymore to run this. A normal lab technician running the core lab … is also able to run mass spectrometry in the future." 

CEO Sause added that feedback from laboratories that have done early evaluations of the platform has been very positive. 

While multiple companies, including Danaher's Sciex and Thermo Fisher Scientific, have tried and failed to gain traction with fully automated clinical mass spectrometry instruments, Roche has high hopes for its platform. Lilienfeld said that he doesn't know why Thermo Fisher failed with its Cascadion instrument but noted that Roche has "vast experience in bringing technologies that used to be lab-developed to the market and [making] it IVD." 

Molecular testing upgrades 

Roche's molecular testing business will also see changes over the coming years, with multiple instrument upgrades coming. A second version of the high-throughput Cobas 6800 and Cobas 8800 instruments will be launching by the end of 2024, with increased testing flexibility and greater automation, said Nico Michel, lifecycle leader for infectious diseases in the molecular lab business. The update will be retrofittable, meaning existing customers will gain access to the new features. 

Users will be able to run up to six different tests per run and can add an optional second thermocycler to the Cobas 6800, which will increase active testing time from 384 results per eight-hour shift to 576 results per shift. The full assay menu will be available for the update, Michel said. 

In 2025, the company also plans to launch a gastrointestinal infection panel on the updated Cobas Eplex platform, which came with Roche's 2021 acquisition of GenMark Diagnostics and launched last month. The GI panel will target 19 bacteria, parasites, and viruses and will introduce dynamic panel ordering, allowing laboratories to develop their own specific sub-panels that best meet the needs of their healthcare system, Michel said. The addition of the GI panel to the existing respiratory panel and blood culture identification panel on Eplex will help "accelerate placements of the system and growth of revenue in the … syndromic panel testing market," he added. 

Roche will also introduce a respiratory flex panel using its new Temperature Activated Generation of Signal (TAGS) technology on the Cobas 5800, 6800, and 8800 instruments that will detect and differentiate between 12 respiratory viruses. The technology allows detection of up to 15 individual targets within one PCR sample, using five channels with three probes — one conventional and two TAGS probes — to differentiate three targets per channel. The TAGS signal is delayed until thermal activation at medium and high temperatures. 

The respiratory flex panel will be the first of multiple assays using the new tech, Michel said, and will be launched in CE markets in 2024, with the US to follow.