Test Catalog

Test Id : CLD18

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Claudin 18 (CLDN18) (43-14A), Semi-Quantitative Immunohistochemistry, Manual

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identification of tumor cells expressing claudin 18

 

As an aid in screening patients who may be eligible for VYLOY (zolbetuximab) treatment

Method Name
A short description of the method used to perform the test

Immunohistochemistry (IHC)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

CLDN18, SemiQuant IHC, Manual

Aliases
Lists additional common names for a test, as an aid in searching

CLDN18

Claudin 18

Claudin 18.2

GPCLDN18

43-14A

ISCLDN18IHC

Specimen Type
Describes the specimen type validated for testing

Special

Shipping Instructions

Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.

Necessary Information

A pathology/diagnostic report and a brief history are required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Specimen Type: Tissue

Supplies: Pathology Packaging Kit (T554)

Collection Instructions: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue

Additional Information: One slide will be stained with hematoxylin and eosin and returned.

Forms

If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Decalcified paraffin embedded tissue
Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or Zinc formalin
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
Refrigerated

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identification of tumor cells expressing claudin 18

 

As an aid in screening patients who may be eligible for VYLOY (zolbetuximab) treatment

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Claudin 18 (CLDN18) is a member of the claudin protein family that regulates cell adhesion. A qualitative immunohistochemistry assessment using mouse monoclonal anti-claudin 18, clone 43-14A, serves as a biomarker in gastric and gastroesophageal junction cancer and may aid in identifying patients eligible for VYLOY (zolbetuximab) treatment.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

Claudin 18.2 is a biomarker for gastric and gastroesophageal junction cancer. When positive (defined as at least moderate membranous staining in greater than or equal to 75% of viable tumor cells), it predicts response to zolbetuximab which has been approved for the treatment of gastric and gastroesophageal adenocarcinoma.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test has been validated for nondecalcified paraffin-embedded tissue specimens fixed in 10% neutral-buffered formalin. Recommended fixation time is between 6 and 48 hours. This assay has not been validated on tissues subjected to the decalcification process or use of alternative fixatives for bone and bone marrow specimens or cell blocks.

 

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Kubota Y, Kawazoe A, Mishima S, et al. Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer. ESMO Open. 2023;8(1):100762

2. Cao W, Xing H, Li Y, et Al. Claudin18.2 is a novel molecular biomarker for tumor-targeted immunotherapy. Biomark Res. 2022;10(1):38

3. Pellino A, Brignola S, Riello E, et al. Association of CLDN18 protein expression with clinicopathological features and prognosis in advanced gastric and gastroesophageal junction adenocarcinomas. J Pers Med. 2021;11(11):1095

4. Arnold A, Daum S, von Winterfeld M, et al. Prognostic impact of Claudin 18.2 in gastric and esophageal adenocarcinomas. Clin Transl Oncol. 2020;22(12):2357-2363

Method Description
Describes how the test is performed and provides a method-specific reference

Immunoperoxidase staining and detection of Claudin 18 (CLDN18) is performed in formalin-fixed, paraffin-embedded tissue sections using the VENTANA CLDN18 (43-14A) RxDx Assay. The 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval and peroxidase inhibitor, incubated with a monoclonal antibody (clone 43-14A), and visualized using a proprietary kit detection system. Sections are counterstained with hematoxylin. Stained slides are examined microscopically by the consulting anatomic pathologist.(Package insert: VENTANA CLDN18 (43-14A) RxDx Assay. Ventana Medical Systems, Inc.; 1016387US Rev A, 10/11/2024)

 

Results are interpreted using the manufacturer-provided interpretation guide.(Instruction manual: VENTANA CLDN18 (43-14A) RxDx Assay Interpretation Guide for Gastric Adenocarcinoma including Gastroesophageal Junction (GEJ). Ventana Medical Systems, Inc.; 1021576EN Rev B, 10/01/2024)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Until reported

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88360

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CLD18 CLDN18, SemiQuant IHC, Manual 105011-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
620666 Interpretation 50595-8
621004 Participated in the Interpretation No LOINC Needed
621005 Report electronically signed by 19139-5
621006 Material Received 81178-6
621007 Disclaimer 62364-5
621008 Case Number 80398-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2024-03-26