RegulatoryCompany release

Roche wins CE Mark for compact cobas smart e immunoanalyser aimed at small labs

Roche · Tue 27 Oct 2026

Roche says its benchtop cobas smart e immunoassay platform, planned to offer over 100 assays, can bring central-lab-comparable results to smaller laboratories and clinics.

Roche announced on 27 October 2026 that its cobas smart e immunoanalyser has received the CE Mark. The benchtop immunoassay platform occupies about 0.9 m², making it a compact option for smaller laboratories and clinics.

The company plans to offer more than 100 assays on the system. These will be introduced in sequential waves rather than all at once, so the available menu will build up over time.

According to Roche, the analyser uses the same reagents and Elecsys technology as its e 402 and e 801 units. The company says this allows smaller sites to run testing in-house and obtain results comparable to those produced in central laboratories.

The source material available to VigiEye did not include details on assay launch timetables, pricing, availability by country or any US regulatory status, so these remain unconfirmed.

What it means for your team

  • Quality teams at smaller sites should note that Roche positions results as comparable to central-lab output because the reagents and Elecsys technology match the e 402 and e 801; any comparability claims should still be verified locally.
  • Regulatory and procurement teams should track the sequential assay launch waves to see when specific tests needed by their labs become available.
  • Market-access and laboratory-network planners may see scope to move some immunoassay testing in-house, but no pricing or country availability has been disclosed.

Company's press release: Roche ↗

Article written by VigiEye from the official source (Roche). Claims are the company's own. AI-assisted; check the source before acting.

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