VENTANA CLDN18 (43-14A) RxDx Assay - Immunohistology cell marker IVDs

Intended purpose

Intended for laboratory use in the assessment of claudin 18 (CLDN18) protein in formalin-fixed, paraffin-embedded (FFPE) gastric adenocarcinoma including gastroesophageal junction (GEJ) tissue specimens stained on a BenchMark IHC/ISH instrument. The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with zolbetuximab in accordance with the approved therapeutic product labelling.

Functional description

The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with zolbetuximab in accordance with the approved therapeutic product labelling