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The stain that decides whether stomach or junction cancer is claudin 18.2-positive and so eligible for zolbetuximab.
Ventana Medical Systems' (Roche Tissue Diagnostics) CLDN18 (43-14A) RxDx Assay was approved on 18 October 2024 (PMA P230018) as the companion diagnostic for zolbetuximab in gastric or gastro-oesophageal junction adenocarcinoma.
Immunohistochemistry with the 43-14A antibody; the FDA list defines a positive result as claudin 18 staining in at least 75% of viable tumour cells. Connects to Claudin 18.2.
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Companion diagnostic for zolbetuximab in gastric or GEJ adenocarcinoma (claudin 18 in at least 75% of viable tumour cells) |
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Query for this drug: (TITLE:"VENTANA CLDN18 43-14A RxDx Assay" OR ABSTRACT:"VENTANA CLDN18 43-14A RxDx Assay" OR TITLE:"VENTANA CLDN18" OR ABSTRACT:"VENTANA CLDN18" OR TITLE:"43-14A RxDx Assay" OR ABSTRACT:"43-14A RxDx Assay") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about VENTANA CLDN18 (43-14A) RxDx Assay, not a curated reading list.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
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