Compact Immunoanalyzer Gains CE Mark for Testing Across Local Care Settings

These pressures highlight the need for consistent immunoassay testing across cardiometabolic, oncology, and infectious disease applications. A new compact immunoanalyzer from Roche aims to meet these needs in decentralized laboratories.

Roche has received the CE mark for the cobas smart e immunoanalyzer, a compact standalone platform engineered to deliver central-laboratory performance in a footprint of less than one square meter. As the newest member of the cobas immunoassay testing family, it is intended to complement the cobas e 402 and cobas e 801 analytical units. These units run up to 120 and 300 tests per hour, respectively, while the cobas smart e processes up to 60 tests per hour.

The cobas smart e shares the universal reagent carriers and Elecsys technology used by Roche’s high-throughput central laboratory platforms. It accommodates 36 reagent positions and has a planned menu of more than 100 high-medical-value assays spanning cardiometabolic, oncology, infectious diseases, and other disease areas. More than 90% of Roche immunoassays have reaction times of 18 minutes or less, with routine testing on the system also completed using reaction times of 18 minutes or less.

Alongside these testing capabilities, the system is designed to reduce hands-on laboratory work through guided, step-by-step tasks and minimal maintenance requirements. According to Roche, it requires one minute of daily operator intervention and reduces hands-on maintenance by up to two-thirds compared with previous-generation platforms. A load of 36 samples provides up to two hours of walk-away time, while an integrated water tank, standard power compatibility, and a dust-protection design support operation in more challenging environments.

The platform is positioned to support small local clinics, decentralized sites, and larger hospital laboratory networks using comparable immunoassay results across locations. Roche also notes that the planned assay menu will be launched in sequential waves. Additional information is being presented at the International Federation of Clinical Chemistry (IFCC) World Congress in New Delhi, India, from October 25-29, 2026.

“For smaller hospitals and laboratories, maintaining central-lab quality has traditionally meant outsourcing tests. 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," said Matt Sause, CEO of Roche Diagnostics.