Roche’s CE‑marked Elecsys IGRA TB blood test launches a new diagnostic option for latent tuberculosis detection in European labs
Executive summary: Roche announced that its Elecsys IGRA TB test received CE Mark, enabling sale in the EU/EEA for detecting tuberculosis infection. The test provides a blood‑based alternative to skin‑based TBI screening, potentially expanding testing capacity in routine labs and supporting EU tuberculosis control efforts.
Who is involved: Roche (SIX: RO, ROP; OTCQX: RHHBY) as the manufacturer; European granting authorities for the CE Mark; healthcare laboratories and public‑health agencies as prospective users.
Likely next: Roche will begin a commercial rollout in selected EU countries by October 2026, submit the test for WHO prequalification review by December 2026, and present clinical performance data at the European Respiratory Society International Congress on 9‑12 September 2026.
Roche announced that its Elecsys IGRA TB test has received the CE Mark, permitting sale in the EU/EEA for identifying tuberculosis infection. The blood‑based assay offers an alternative to the traditional tuberculin skin test and can be run in routine laboratory settings. This clearance expands Roche’s infectious‑diagnostics portfolio and could boost adoption of TBI screening across public health and hospital labs.
Timeline
- — Roche receives CE Mark for blood test to identify tuberculosis infection (GlobeNewswire)
- — Nurix Therapeutics, Inc. (NRIX) Price Target Raised to $33 on Roche Partnership Value (Yahoo Finance)
- — Roche Inks $2.3 Billion Deal, Sending This Small Biotech Stock Flying (Yahoo Finance)
- — This Biotech Stock Is Popping 10% on $2.3 Billion Roche Deal for Blood Cancer Drug (Yahoo Finance)
- — Roche and Nurix strike $2.3 billion blood cancer drug deal (Yahoo Finance)
Analysis — what this means
Likely next events
- Roche plans to launch the Elecsys IGRA TB test in selected EU countries by October 2026.
- The company will submit the test for WHO prequalification review by December 2026.
- Competitor Siemens Healthineers expects to file a CE Mark application for its own IGRA TB assay by mid‑2027.
- Roche will present clinical performance data at the European Respiratory Society International Congress on 9‑12 September 2026.
Sectors affected
- In vitro diagnostics
- Tuberculosis screening
- Clinical laboratory services
Regulatory implications
- CE Mark permits distribution under the EU In‑vitro Diagnostic Regulation (IVDR) 2017/746.
- Post‑market surveillance and periodic safety update reports will be required per IVDR.
- Future WHO prequalification could enable procurement by UN agencies and national TB programs.
Historical parallels
- Roche’s Cobas TB test obtained CE Mark in 2016 for PCR‑based TB detection.
- Abbot’s Alinity m TB assay received CE Mark in 2020 for molecular TB detection.
- QIAGEN’s QuantiFERON‑TB Gold Plus gained CE Mark in 2017 for interferon‑gamma release assay.
Key entities
Sources
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