Roche’s Ventana CLDN18 (43-14A) RxDx Assay Receives CE Mark Approval to Diagnose G/GEJ Cancer Patients with CLDN18 Protein Expression
Shots:
- Roche's Ventana CLDN18 (43-14A) RxDx Assay has received CE certificate to determine CLDN18 protein expression in G/GEJ adenocarcinoma patients, who will then be treated with Astellas' Vyloy (zolbetuximab). It will enable therapeutic decision-making
- Approval was supported by SPOTLIGHT & GLOW trials that employed the assay to determine G/GEJ patients with CLDN18.2 +ve tumors and found ~38% of them with the same. Patients were administered with Vyloy + CT, leading to a 25-31% reduced disease progression/death
- The assay is a qualitative IHC test for evaluating CLDN18 (18.1 & 18.2 isoforms) protein expression in G/GEJ adenocarcinomas using the OptiView DAB IHC Detection Kit on a BenchMark ULTRA instrument
Ref: Roche | Image: Roche
Related News:- Roche Reports Topline Data from P-III (REGENCY) Trial of Gazyva/Gazyvaro (Obinutuzumab) for Treating Lupus Nephritis
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
