Test Catalog

Test Id : KRASW

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KRAS Somatic Mutation Analysis, Peritoneal Fluid

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Overview

Test Catalog

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

Staging of the pancreatic ductal adenocarcinoma(1)

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

Droplet Digital Polymerase Chain Reaction (ddPCR)

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

KRAS Mutation Analysis, Peritoneal

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

Cetuximab (Erbitux)

Colorectal cancer

CRC

EGFR

Epidermal growth factor receptor

Erbitux (Cetuximab)

KRAS

KRAS codon 12

KRAS codon 13

KRAS codon 146

KRAS codon 61

KRAS G12C

KRAS WT

Non-small cell lung cancer

NSCLC

Patiumumab (Vectibix)

RAS

Vectibix (Patiumumab)

Specimen Type
Describes the specimen type validated for testing

Peritoneal

Necessary Information

1. A pathology report (final or preliminary) is required and must accompany specimen for testing to be performed.

2. The following information must be included in the report provided.

-Patient name and second identifier

-Date of fluid collection

-Source of the fluid

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

Container/Tube: 50-mL Falcon tube

Preferred: Fresh, peritoneal washing; no fixatives added to wash

Specimen Volume: Two 50-mL Falcon tubes

Collection Instructions: Containers must be labeled with two unique patient identifiers.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

100 mL of peritoneal washing

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

Fixative added 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
Peritoneal Refrigerated (preferred) 10 days
Ambient 5 days

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

Staging of the pancreatic ductal adenocarcinoma(1)

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

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with predilection for peritoneal dissemination. Accurate peritoneal staging is important for management of patients with PDAC. The KRAS oncogene is the most frequently mutated oncogene in PDAC. Detection of KRAS mutations within peritoneal fluid has been associated with clinically positive laparoscopic findings (gross metastases and/or positive peritoneal cytology) and elevated peritoneal fluid carbohydrate antigen 19-9 and/or carcinoembryonic antigen and may portend an increased risk of residual/recurrent pancreatic cancer metastases within the peritoneal cavity.

 

This test uses DNA extracted from cells shed into the peritoneum to evaluate for the presence of KRAS (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutations. A positive result indicates the presence of an activating KRAS mutation and can be a useful marker to aid in the staging of pancreatic ductal adenocarcinoma.

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

The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.

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

Patients with a negative test result may still harbor a KRAS mutation below the level of detection.

 

The limit of detection of this assay is influenced by the amount of cells and DNA in the peritoneal wash. This is a biological variable that cannot be controlled.

 

This assay was designed to detect mutations in KRAS codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T).

 

This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.

 

This test cannot differentiate between somatic and germline alterations.

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

1. Yonkus JA, Alva-Ruiz R, Abdelrahman AM, et al. Molecular peritoneal staging for pancreatic ductal adenocarcinoma using mutant KRAS droplet-digital polymerase chain reaction: Results of a prospective clinical trial. J Am Coll Surg. 2021;233(1):73-80.e1. doi:10.1016/j.jamcollsurg.2021.05.009

2. Kim NH, Kim HJ. Preoperative risk factors for early recurrence in patients with resectable pancreatic ductal adenocarcinoma after curative intent surgical resection. Hepatobiliary Pancreat Dis Int. 2018;17(5):450-455 doi:10.1016/j.hbpd.2018.09.003

3. Avula LR, Hagerty B, Alewine C. Molecular mediators of peritoneal metastasis in pancreatic cancer. Cancer Metastasis Rev. 2020;39(4):1223-1243. doi:10.1007/s10555-020-09924-4

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

Droplet digital polymerase chain reaction is used to test for the presence of KRAS codon 12, 13, 61, and 146 mutations.(Yonkus JA, Alva-Ruiz R, Abdelrahman AM, et al. Molecular peritoneal staging for pancreatic ductal adenocarcinoma using mutant KRAS droplet-digital polymerase chain reaction: Results of a prospective clinical trial. J Am Coll Surg. 2021;233[1]:73-80.e1. doi:10.1016/j.jamcollsurg.2021.05.009)

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 10 days

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

Extracted DNA: 3 months

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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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.

81275-KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, variants in codons 12 and 13

81276-KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, additional variants

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
KRASW KRAS Mutation Analysis, Peritoneal 21702-6
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.
616453 Result Summary 50397-9
616454 Result 82939-0
616455 Interpretation 69047-9
616456 Specimen 31208-2
616457 Source 31208-2
616459 Released By 18771-6
616460 Method 85069-3
616461 Disclaimer 62364-5
616462 Additional Information 48767-8

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
Test Changes - Specimen Information 2024-12-19
Test Changes - Specimen Information 2024-08-14