Claudin 18.2 immunohistochemistry testing using the VENTANA® CLDN18 (43-14A) clone, which is a FDA approved assay, can identify patients whose tumour tissue showing expression of the protein under a specific cut-off, to be benefited from treatment by zolbetuximab (VYLOY® ), which is a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, together with fluoropyrimidine- and platinum-containing chemotherapy, as the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction adenocarcinomas.

 

The FDA approval of the drug and its companion diagnostic can be found in the following site:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric-or-gastroesophageal-junction-adenocarcinoma

 

Specimen requirements: FFPE tissue unstained sections on coated slides (4µm)

Turnaround time: 5 working days from day of specimen received