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

Original from: Roche

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. 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 90% of Roche immunoassays, local facilities can help reduce diagnostic turnaround times.

“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. 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.

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.

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. 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.

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.

Source: 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