CLDN18.2

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Reporting test results

Best practices for accurate and consistent reporting of CLDN18.2 expression and positivity.

Both membrane stain intensity and percentage of tumour cells stained are essential for CLDN18.2 reporting1

In addition to membranous stain intensity and percentage of tumour cells stained, it is recommended that the biomarker report also include:

  • Type of testing method and antibody used, including companion diagnostic vs laboratory-developed test and antibody clone
  • A description of the status of the sample, such as “positive,” “negative,” or “inconclusive” 
  • Any relevant notes or observations regarding the sample or results
CLDN18.2-positivity is defined as ≥ 75% of tumour cells demonstrating moderate to strong (2+/3+) membranous CLDN18 staining, based on IHC assessments in 2 recently published global Phase 3 studies.1-3
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CLDN18.2 reporting template

Developed by a committee of experts, this template can help you generate reporting and integrate CLDN18.2 reporting into your current protocols.

Consistent, integrated reporting of biomarkers can inform clinical decision-making and may improve patient care4

 

Integrated biomarker reporting

  • Gives the HCP the ability to review biomarker test results that inform their clinical approach
  • Can be used as a tool to help pathologists educate the multidisciplinary team

 

Pathologists drive consistent, integrated reporting, helping their multidisciplinary teams optimize treatment plans.

CLDN18.2=claudin 18 isoform. G/GEJ=gastric/gastroesophageal junction. IHC=immunohistochemistry.

References: 1. Fassan M, Kuwata T, Matkowskyj KA, et al. Claudin-18.2 immunohistochemical evaluation in gastric and gastroesophageal junction adenocarcinomas to direct targeted therapy: a practical approach. Mod Pathol. 2024;37(11):100589. 2. Shitara K, Xu RH, Ajani JA, et al. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Gastric Cancer. 2024;27(5):1058-1068. 3. Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023;29(8):2133-2141. 4. Warner JL, Jain SK, Levy MA. Integrating cancer genomic data into electronic health records. Genome Med. 2016;8(1):113. 10-26-2016.