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FDA-approved companion diagnostic

Ventana CLDN18 (43-14A) RxDx Assay

Qualitative IHC assay using anti-CLDN18 (43-14A) to detect CLDN18.2 protein expression in FFPE gastric and GEJ adenocarcinoma tissue for treatment planning.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: CLDN18.2 protein expression
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About this test

FDA approval details
PMA number
P230018
Supplements
Manufacturer
Ventana Medical Systems, Inc. (Roche Diagnostics)
Approval date
October 18, 2024
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
CLDN18.2 protein expression
What this test is

VENTANA CLDN18 (43-14A) RxDx Assay is an FDA-approved, qualitative immunohistochemistry test that uses a rabbit monoclonal anti-CLDN18 antibody to detect CLDN18.2 protein expression in FFPE gastric and gastroesophageal junction adenocarcinoma tissue. It classifies tumors as CLDN18.2 positive or negative to support selection of CLDN18.2-targeted treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaClaudin 18 (CLDN18)Claudin 18 (CLDN18) protein expression (≥75% viable tumor cells (% TC) staining)VYLOY

IVD Manufacturer

Ventana Medical Systems, Inc. (Roche Diagnostics)

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Order this test

If your organization is connected to Casandra, you can place an electronic order forVentana CLDN18 (43-14A) RxDx Assay directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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