Roche Gets CE Mark for cobas smart e, a Benchtop Immunoanalyser With 100+ Planned Assays

Roche received the CE Mark for its cobas smart e immunoanalyser, a compact benchtop platform with a planned menu of over 100 high-medical-value assays, the company said on October 27, 2026. Stock Titan reported the approval. Roche is a Swiss pharmaceutical and diagnostics company that develops prescription medicines and companion diagnostic tests across oncology, neurology, immunology, ophthalmology and infectious diseases.

Roche's cobas smart e Platform Details

The cobas smart e is a standalone immunoanalyser with a footprint under one square metre and 36 reagent positions. Roche said the platform delivers reaction times of 18 minutes or less for more than 90% of its immunoassays, allowing smaller laboratories to bring testing in-house. The system uses the same reagents and Elecsys technology as Roche's high-throughput platforms, which the company said ensures comparability of clinical results across a hub-and-spoke network.

"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."

The platform requires one minute of daily operator intervention and reduces hands-on maintenance by up to two-thirds compared to previous-generation platforms, according to the company. It has an integrated water tank, standard power compatibility and a dust-protection design. Roche said the planned assay menu covers cardiometabolic, oncology and infectious diseases, launched in sequential waves.

Roche's Diagnostics Investment Record

Roche confirmed in June 2026 that it will not pull its previously announced €600 million investment for a diagnostic production site in Penzberg, Germany, according to akta.pro company records. The same records show Roche committed to a Most-Favoured-Nation pricing framework in the US alongside Novartis, securing three-year tariff exemptions and aligning with a broader $200 billion+ US investment pledge by Swiss pharma, including $67 billion in 2026, that lowered the US tariff rate on Swiss exports from 39% to 15%.

Roche's Recent Regulatory and Deal Activity

Roche will seek European approval for its breast cancer drug giredestrant later than it once expected, a delay that highlights how US drug pricing pressure, via most-favored-nation rules, complicates European launches, Endpoints News reported in October 2026. Roche announced phase III Krascendo 1 results showing divarasib monotherapy cut death risk by 44% versus sotorasib or adagrasib in previously treated KRAS G12C-mutated lung cancer, Stock Titan reported in October 2026. Zymeworks licensed its experimental lung cancer drug ZW209 to Roche for up to $813 million, including $55 million upfront and $40 million for a dose-optimization study, Reuters reported in October 2026.

Roche's cobas smart e at IFCC 2026

Roche said it will present the cobas smart e immunoanalyser at the International Federation of Clinical Chemistry and Laboratory Medicine Conference in New Delhi, India, from October 25 to 29, 2026. The company said the platform's assay menu will be launched in sequential waves.