Roche receives CE Mark for cobas® smart e immunoanalyser, completing a portfolio that brings central-lab precision to healthcare settings ranging from small clinics to large hospital laboratories
Roche’s immunoassay portfolio now spans small local clinics through the highest-volume hospital laboratories.
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Rhea-AI Summary
Roche (RHHBY) has received the CE Mark for its cobas smart e immunoanalyser, a standalone testing platform for smaller laboratories.
The system complements Roche’s cobas e 402 and cobas e 801 analytical units and uses the same reagents and Elecsys technology. Roche plans a menu of over 100 assays, launched in sequential waves. The platform occupies under one square metre, with reaction times of 18 minutes or less for more than 90% of Roche immunoassays. Roche says it enables smaller facilities to bring testing in-house and reduce diagnostic turnaround times.
Positive
- Minor pointCE Mark received for cobas smart e, adding a cleared platform to Roche’s immunoassay portfolio.
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- The cobas smart e immunoanalyser – the newest addition to Roche’s industry-leading cobas immunoassay systems portfolio – is engineered to deliver central-lab performance in a footprint under one square metre.
- With a planned menu of over 100 high-medical-value assays, and reaction times of 18 minutes or less for more than
90% of tests, the platform allows smaller laboratories to bring testing in-house, reducing turnaround times for patients.1,2,3 - The cobas smart e uses the same reagents and Elecsys® technology as Roche's high-throughput platforms, optimising patient management with consistent test results over time and across different locations.
Basel, 27 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received the CE Mark for its cobas smart e immunoanalyser, a compact, standalone platform engineered to deliver reliable testing with a planned menu of over 100 high-medical-value assays.1,2 As the latest offering in Roche’s industry-leading cobas immunoassay systems portfolio, the platform bridges critical operational gaps across health systems by fitting central-laboratory precision into a footprint under one square meter. This enables decentralised sites to manage diverse testing demands directly in-house. With reaction times of 18 minutes or less across more than
“For smaller hospitals and laboratories, maintaining central-lab quality has traditionally meant outsourcing tests,” said Matt Sause, CEO of Roche Diagnostics. “The cobas smart e immunoanalyser fits on a benchtop, bringing Roche's immunoassay standards directly into these care settings. This means our cobas® immunoassay solutions now span the full range of healthcare settings while delivering consistent high-quality results, ensuring patients get timely, accurate answers, no matter where they live."
The cobas smart e immunoanalyser joins the cobas® e 402 and cobas® e 801 analytical units, which run up to 60, 120 and 300 tests an hour respectively. Together, they scale from small local clinics to the highest-volume hospital laboratories, using the same universal reagents and Elecsys® technology, which helps ensure comparability of clinical results.
Across global healthcare systems, acute workforce shortages continue to strain diagnostic delivery, as health systems confront a projected global shortfall of 11 million health workers by 2030.4 The cobas smart e immunoanalyser combines minimal maintenance with guided, step-by-step tasks to simplify workflows and improve the productivity of lab personnel while also supporting the delivery of better patient care. Requiring just one single minute of daily operator intervention, the system reduces hands-on maintenance efforts by up to two-thirds compared to previous-generation platforms.1,2
In addition to easing staffing pressures, the platform is engineered to withstand challenging physical and environmental conditions that often limit testing in decentralised settings. Equipped with an integrated water tank, standard power compatibility and a dust-protection design, the utility-independent engineering of the cobas smart e immunoanalyser bypasses traditional infrastructural barriers, enabling uninterrupted service across rural and resource-constrained clinics.1,2
Featuring an expansive planned menu of over 100 high-medical-value assays across critical disease areas — including cardiometabolic, oncology and infectious diseases — the cobas smart e immunoanalyser enables low-volume labs to bring essential testing in-house, reducing the delay and cost of sending samples out.1,2,3 Furthermore, because it utilises the same universal reagent carriers and Elecsys® technology as Roche's high-throughput central laboratory platforms, it ensures comparability of clinical results across an entire hub-and-spoke network.1,2
For more information, visit the Roche booth at the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Conference in New Delhi, India from 25 - 29 October 2026.
About the cobas smart e immunoanalyser
The cobas smart e immunoanalyser is the newest member of the cobas immunoassay testing family. It holds 36 reagent positions on a compact benchtop footprint of ~0.9 m² with a planned menu of over 100 assays, across a wide range of disease areas which will be launched in sequential waves.1,2,3 Designed to support customers focused on maximising efficiency for their time, space and their teams, the cobas smart e immunoanalyser has a high uptime while requiring less hands-on time, with up to 2 hours of walk-away time on a load of 36 samples.1,2 The possible immunoassay reaction time for routine and emergency samples are the lowest available on the central laboratory market, with a reaction time of 18 minutes or less for routine testing.1,2 This new immunoanalyser complements cobas e 801 and cobas e 402 analytical units for immunoassay testing as it uses the same reagent packs, system reagents and well-established Elecsys technology. For more information, visit cobas.com.
To find out more about Roche’s cobas® smart e immunoanalyser, click here
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] cobas® smart e analyzer user guide – pre-launch version 0.1 – data on file
[2] Ref-13688 cobas e 411 Operator Manual V 3.3.1
[3} Ref: SWA assay menu and reagent specifications analysis | Data on file | Source: Reagent method sheets.
[4] World Health Organization. Health workforce. https://www.who.int/health-topics/health-workforce#tab=tab_1 (Accessed August 2026).
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FAQ
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What regulatory milestone has Roche’s cobas smart e immunoanalyser achieved?
Roche has received the CE Mark for its cobas smart e immunoanalyser. The compact, standalone platform joins the company’s cobas immunoassay portfolio and is designed for smaller laboratories.