VENTANA CLDN18 (43-14A) RxDx Assay* is a qualitative immunohistochemical assay intended for laboratory use in the assessment of Claudin 18 (CLDN18) protein in formalin fixed, paraffin-embedded (FFPE) gastric adeno- carcinoma including gastroesophageal junction (GE J) tissue stained with OptiView DAB IHC Detection Kit on a BenchMark ULTRA IHC/ISH instrument.
1 Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: CancerToday. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today. Accessed 20 September 2024. 2 Brenner et al. Projected estimates of cancer in Canada in 2024, CMAJ, May 13, 2024, Volume 196, Issue 18, doi: 10.1503/cmaj.240095
1 Astellas press release, Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium. https://www.astellas.com/en/news/26946. Accessed June 12, 2023. 2 Astellas press release, Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series. https://www.astellas.com/en/news/27481. Accessed June 12, 2023. 3 Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet 2023;401(10389):1655-1668.4 Shah, M.A., Shitara, K., Ajani, J.A. et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med 2023;29:2133-2141.
1 Roche. VENTANA CLDN18 (43-14A) RxDx Assay, Package Insert (1021574EN Rev A), 2024.2 Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab + mFOLFOX6 as 1L treatment for patients with CLDN18.2+/HER2- locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: primary phase 3 results from SPOTLIGHT. Presented at: ASCO Gastrointestinal Cancers Symposium; January 19-21, 2023; San Francisco, CA. 3 Xu R, Shitara K, Ajani J, et al. Zolbetuximab + CAPOX in 1L claudin-18.2+ (CLDN18.2+)/HER2- locally advanced (LA) or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: primary phase 3 results from GLOW. Presented at: ASCO March Plenary Session; March 22, 2023. 4 Hong JY, et al. Claudin 18.2 expression in various tumor types and its role as a potential target in advanced gastric cancer. Transl Cancer Res. 2020 May;9(5):3367-3374.
Self-paced digital training program that will include:
●Biology and background on the assay
●Guided interpretation of the assay
●Interactive mini-test on scoring sample cases
* Please refer to the VENTANA CLDN18 (43-14A) RxDx Assay method sheet for the full intended use statement and approved therapeutic labeling