Roche cobas smart e immunoanalyser gains CE Mark
- Roche received CE Mark for the cobas smart e compact immunoanalyser.
- Benchtop footprint of ~0.9 m² with 36 reagent positions and a planned menu of over 100 high-medical-value assays.
- More than 90% of tests have reaction times of 18 minutes or less, with up to 2 hours walk-away on 36 samples.
- Operational design requires ~1 minute daily operator intervention, claims up to two-thirds less hands‑on maintenance, and includes integrated water tank, standard power compatibility and dust protection for decentralised sites.
Product and regulatory status
Roche has secured CE Mark approval for the cobas smart e immunoanalyser, a compact standalone platform designed to bring central-lab immunoassay performance into smaller laboratories and decentralised care settings.
Performance and assay menu
The system has a benchtop footprint of roughly 0.9 m², holds 36 reagent positions and carries a planned menu of more than 100 high‑medical‑value assays across cardiometabolic, oncology and infectious disease areas. Roche states that over 90% of immunoassays will have reaction times of 18 minutes or less and that the analyser supports up to 2 hours of walk‑away time on a 36‑sample load.
Operations and deployment
The cobas smart e is engineered for low maintenance and simplified workflows, requiring about one minute of daily operator intervention and claiming up to a two‑thirds reduction in hands‑on maintenance versus prior platforms. It includes an integrated water tank, standard power compatibility and a dust‑protection design to support use in rural and resource‑constrained environments.
Integration within Roche’s portfolio
The analyser uses the same Elecsys technology and universal reagent carriers as Roche’s higher‑throughput cobas immunoassay platforms, enabling result comparability across hub‑and‑spoke networks and complementing devices that scale to higher test rates (noted platform throughputs include 60, 120 and 300 tests/hour).
Source: Roche