RegulatoryCompany release

Roche launches VENTANA BAP1 (SP527) assay worldwide to aid mesothelioma diagnosis

Roche · Wed 28 Oct 2026

The automated immunohistochemistry test is FDA-registered as Class I and carries IVDR Class C approval in the EU, and joins Roche's recent MTAP and Claudin-4 assays.

Roche announced on 28 October 2026 the global launch of its VENTANA BAP1 (SP527) assay, an automated immunohistochemistry test intended to support pathologists in diagnosing malignant mesothelioma.

According to the company, the assay helps distinguish malignant mesothelioma from lung, breast and stomach cancers, as well as from benign growths. These differential diagnoses are a routine challenge in mesothelioma work-ups.

On regulatory status, Roche says the test is registered with the US Food and Drug Administration as a Class I in vitro diagnostic (IVD). In the European Union it has approval under the In Vitro Diagnostic Regulation (IVDR) as a Class C device.

The BAP1 assay follows Roche's recently launched MTAP and Claudin-4 assays. Roche states the aim of the portfolio is to reduce the amount of tissue consumed in diagnosis, so that enough sample remains for molecular testing.

What it means for your team

  • Regulatory teams tracking IVDR can note another Class C immunohistochemistry assay reaching the EU market under the new framework.
  • The FDA position is registration as a Class I IVD, a lower-risk category than devices requiring premarket clearance or approval; as general context, Class I devices are typically exempt from premarket notification.
  • Laboratory and quality teams may want to consider how the combined BAP1, MTAP and Claudin-4 panel affects tissue use and the availability of material for downstream molecular testing.

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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