Test Catalog

Test Id : KRASP

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KRAS Somatic Mutation Analysis, Tumor

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Overview

Test Catalog

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

Detecting molecular markers associated with response or resistance to specific cancer

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
SLIRV Slide Review in MG No, (Bill Only) Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, slide review will always be performed at an additional charge.

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

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

Digital Droplet 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 Somatic Mutation Analysis

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)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, slide review will always be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Pathology report (final or preliminary) must accompany specimen in order for testing to be performed. At minimum, it should contain the following information:

1. Patient name

2. Block number-must be on all blocks, slides and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue

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

Preferred:

Specimen Type: Tissue

Container/Tube: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block.

 

Acceptable:

Specimen Type: Tissue

Container/Tube: Slides

Specimen Volume: 1 stained and 5 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 5 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.

 

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1 to 3 slides

Collection Instructions: Submit 1 to 3 slides stained and coverslipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells.

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned.

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

Forms

1. Molecular Genetics: Inherited Cancer Syndromes Patient Information (T519) in Special Instructions.

2. If not ordering electronically, complete, print, and send a Oncology Test Request (T729) with the specimen.

 

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.

Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or 1 slide stained with hematoxylin and eosin and 5 unstained, nonbaked slides (5-microns thick sections) of the tumor tissue.

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

Specimens that have been decalcified (all methods)   Specimens that have not been formalin- fixed, paraffin-embedded 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
Varies Ambient (preferred)
Refrigerated

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

Detecting molecular markers associated with response or resistance to specific cancer

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, slide review will always be performed at an additional charge.

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

Strategies that focus on early detection and prevention effectively decrease the risk of mortality associated with cancer. In addition, an increase in survival rate for individuals with advanced stage disease has been observed as a result of advancements in standard chemotherapeutic agents and the development of specialized targeted therapies. Monoclonal antibodies against epidermal growth factor receptor (EGFR), such as cetuximab and panitumumab, represent an area of targeted therapy for patients with colorectal and non-small cell lung cancer (NSCLC). However, studies have shown that not all individuals with colorectal cancer or NSCLC respond to EGFR targeted molecules. Because the combination of targeted therapy and standard chemotherapy leads to an increase in toxicity and cost, strategies that help to identify the individuals most likely to benefit from such targeted therapies are desirable.

 

EGFR is a growth factor receptor that is activated by the binding of specific ligands (epiregulin and amphiregulin), resulting in activation of the RAS/MAPK pathway. Activation of this pathway induces a signaling cascade ultimately regulating a number of cellular processes including cell proliferation. Dysregulation of the RAS/MAPK pathway is a key factor in tumor progression. Targeted therapies directed to EGFR, which inhibit activation of the RAS/MAPK pathway, have demonstrated some success (increased progression-free and overall survival) in patients with cancer, in particular, colorectal cancer and NSCLC.

 

One of the most common somatic alterations in colon cancer and NSCLC is the presence of activating variants in the protooncogene KRAS. KRAS is recruited by ligand-bound (active) EGFR to initiate the signaling cascade induced by the RAS/MAPK pathway. Because altered KRAS constitutively activates the RAS/MAPK pathway downstream of EGFR, agents such as cetuximab and panitumumab, which prevent ligand-binding to EGFR, do not appear to have any meaningful inhibitor activity on cell proliferation in the presence of altered KRAS. Current data suggest that the efficacy of EGFR-targeted therapies in colon cancer and NSCLC is confined to patients with tumors lacking KRAS mutations. An exception is the KRAS G12C variant that is targetable with variant-specific inhibitors.

 

This test uses DNA extracted from tumor tissue to evaluate for the presence of KRAS (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) variants. A positive result indicates the presence of an activating KRAS mutation and can be a useful marker by which patients are selected for EGFR-targeted therapy.

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

An interpretative report will be provided.

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

Not all patients whose tumors have wild-type KRAS respond to epidermal growth factor receptor (EGFR)-targeted therapies.

 

Rare alterations (ie, polymorphisms) exist that could lead to false-negative or false-positive results.

Test results should be interpreted in context of clinical findings, tumor sampling, and other laboratory data. If results obtained do not match other clinical or laboratory findings, please contact the laboratory for possible interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

 

This assay was designed to detect variants 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.Allegra CJ, Rumble BR, Hamilton SR, et al: Extended RAS gene mutation testing in metastatic colorectal carcinoma to predict response to anti-epodermal growth factor receptor monoclonal antibody therapy: ASCO Provisional Clinical Opinion update 2015. J Clin Oncol. 2016 Jan 10;34(2):179-185

2.Spano JP, Milano G, Vignot S, Khayat D: Potential predictive markers of response to EGFR-targeted therapies in colorectal cancer. Crit Rev Oncol Hematol. 2008;66:21-30

3.Lam DC: Clinical testing for molecular targets for personalized treatment in lung cancer. Respirology 2013Feb;18(2):233-237

4.Hong DS, Fakih MG, Strickler JH, et al: KRAS G12C inhibition with sotorasib in advanced solid tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217

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

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

A pathology review and macrodissection to enrich for tumor cells is performed prior to DNA extraction.

 

Digital droplet polymerase chain reaction is used to test for the presence of KRAS codon 12, 13, 61, and 146 variants. (Unpublished Mayo method).

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.

8 to 12 days

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

Unused slides: 5 years;. Extracted DNA: 3 months. Unused portions of blocks will be returned.

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. 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.

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

81276-KRAS additional variant(s)

88381-Microdissection, manual

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
KRASP KRAS Somatic Mutation Analysis In Process
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.
610680 Result Summary 50397-9
610681 Result 82939-0
610682 Interpretation 69047-9
610683 Specimen 31208-2
610684 Source 31208-2
610685 Tissue ID 80398-1
610686 Released By 18771-6
610687 Method 85069-3
610688 Disclaimer 62364-5
614165 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