Roche receives CE Mark for compact cobas smart e immunoanalyser

Roche has received CE Mark approval for its cobas smart e immunoanalyser, a compact benchtop system designed to bring central laboratory immunoassay testing capabilities into smaller hospitals and diagnostic facilities.

The platform occupies less than one square metre and is being developed with a planned menu of more than 100 high-medical-value assays across areas including cardiometabolic disease, oncology and infectious diseases.

Roche said more than 90% of its immunoassays can be completed with reaction times of 18 minutes or less on the system.

The company said the platform could allow smaller laboratories to perform a wider range of tests in-house instead of sending samples to larger central facilities, potentially reducing diagnostic turnaround times.

The cobas smart e uses the same universal reagent carriers and Elecsys technology as Roche’s higher-throughput immunoassay systems.

This is intended to support consistent and comparable results when patients are tested at different sites within the same healthcare network.

Matt Sause, Chief Executive Officer of Roche Diagnostics, said smaller hospitals and laboratories have traditionally needed to outsource some testing to maintain central laboratory standards.

He said the new platform is intended to provide the same immunoassay technology in a smaller format suitable for lower-volume facilities.

The cobas smart e joins Roche’s cobas e 402 and cobas e 801 analytical units.

Together, the systems are designed to cover testing environments ranging from smaller clinics to high-volume hospital laboratories.

The cobas smart e can accommodate 36 reagent positions and has a footprint of approximately 0.9 square metres.

It is designed to provide up to two hours of unattended operation when loaded with 36 samples.

Roche said the system requires around one minute of daily operator intervention and can reduce hands-on maintenance by up to two-thirds compared with previous-generation platforms.

The analyser has also been designed for use in settings where laboratory infrastructure may be more limited.

It includes an integrated water tank, standard power compatibility and dust protection, reducing reliance on some of the infrastructure commonly required by larger central laboratory systems.

Roche said these features could support use in rural and resource-constrained settings while maintaining access to a broad immunoassay menu.

The company is planning to introduce the platform’s more than 100 assays in sequential waves.

The cobas smart e is being showcased at the International Federation of Clinical Chemistry and Laboratory Medicine conference in New Delhi.

---

---

Related Topics and Keywords

Biopharma, cardiometabolic testing, CE Mark, clinical diagnostics, cobas smart e, decentralised testing, Diagnostics, Elecsys, immunoanalyser, immunoassay, in vitro diagnostics, infectious disease testing, IVD, laboratory automation, laboratory diagnostics, medtech, oncology diagnostics, pharma news, point of care, Roche, Roche Diagnostics