Test Catalog

Test Id : KRASD

Order This Test

Cell-Free DNA KRAS 12, 13, 61,146, Blood

Download
Overview

Test Catalog

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

As an alternative to invasive tissue biopsies for the determination of KRAS 12, 13, 61,146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutation status

 

Selection of patients with colorectal cancer who are most likely to benefit from epidermal growth factor receptor (EGFR)-targeted therapies

Genetics Test Information
Provides information that may help with selection of the correct genetic test or proper submission of the test request

This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of KRAS mutations at codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) in patients with colorectal cancer and can be used to assess eligibility for targeted therapies.

 

This test is not validated for serial monitoring of patients with cancer. This test is also not intended as a screening test to identify cancer.

Highlights

This test provides rapid detection of KRAS mutations in colorectal cancer patients as an alternative for KRAS analysis of tissue.

 

Current data suggests that the efficacy of epidermal growth factor receptor (EGFR)-targeted therapy in colorectal cancer patients is limited to patients whose tumors do not harbor mutations in the KRAS gene.

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

Digital Droplet Polymerase Chain Reaction (PCR)

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

cfDNA KRAS 12, 13, 61, 146 Blood

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

CRC

Colorectal cancer

EGFR

Epidermal growth factor receptor

Cell free DNA

cfDNA

cell-free DNA

circulating tumor DNA

liquid biopsy

KRAS WT

KRAS codon 12

KRAS codon 13

KRAS codon 61

KRAS codon 146

Circulating tumor cells

KRAS

RAS

Specimen Type
Describes the specimen type validated for testing

Whole blood

Ordering Guidance

This test is not a prenatal screening test. To evaluate for the presence of common fetal chromosome abnormalities using cell-free DNA, order NIPS / Cell-Free DNA Prenatal Screen.

Shipping Instructions

1. Samples should be transported at ambient temperature or refrigerated (4 degrees C).

2. Samples are viable for 7 days in the Streck Black/Tan Top Tube Kit (T715).

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

Supplies: Streck Black/Tan Top Tube Kit (T715)

Container/Tube: Streck Cell-Free DNA blood collection kit (T715)

Specimen Volume: Two 10-mL Streck Cell-Free DNA blood collection tubes

Additional Information: Only blood collected in Streck Cell-Free DNA BCT tubes will be accepted for analysis. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.

Forms

If not ordering electronically, complete, print, and send an 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

One 10 mL Streck tube

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

No specimen collected in the Streck Cell-Free DNA blood collection tubes will be rejected.

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
Whole blood Ambient (preferred) 7 days Streck Black/Tan top
Refrigerated 7 days Streck Black/Tan top

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

As an alternative to invasive tissue biopsies for the determination of KRAS 12, 13, 61,146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutation status

 

Selection of patients with colorectal cancer who are most likely to benefit from epidermal growth factor receptor (EGFR)-targeted therapies

Genetics Test Information
Provides information that may help with selection of the correct genetic test or proper submission of the test request

This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of KRAS mutations at codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) in patients with colorectal cancer and can be used to assess eligibility for targeted therapies.

 

This test is not validated for serial monitoring of patients with cancer. This test is also not intended as a screening test to identify cancer.

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

Approximately 30% to 50% of colorectal cancers (CRC) have mutations in KRAS. Most occur in hotspot regions in codons 12, 13, 61, and 146. These mutations lead to constitutive activation of the RAS/MAPK pathway downstream of epidermal growth factor receptor (EGFR), limiting the effectiveness of anti-EGFR therapies, such as cetuximab and panitumumab, which inhibit ligand-mediated activation of EGFR. Therefore, identification and quantitation of these mutations is critical in selecting the appropriate therapy.

 

This test uses DNA extracted from peripheral blood 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 may be useful for guiding the treatment of individuals with colorectal cancer.

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided.

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. Mutation testing of a tissue specimen for KRAS mutations should be considered for patients with who have a negative result with this test.

 

The limit of detection of this assay for the detection of KRAS mutations is influenced by the amount of cell-free DNA (cfDNA) in the blood. 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.

Supportive Data

This test has been evaluated by our laboratory as an alternative to assessing paraffin-embedded tumor specimens for KRAS mutations in patients with colorectal cancer. 

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

1. Schwarzenbach H, Hoon DS, Pantel K: Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer 2011;11(6):426-437

2. 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

3. Olmedillas Lopez S, Garcia-Olmo DC, Garcia-Arranz M, et al: KRAS G12V Mutation Detection by Droplet Digital PCR in Circulating Cell-Free DNA of Colorectal Cancer Patients. Int J Mol Sci 2016;17:484

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

Blood samples are collected in Streck Cell-Free DNA BCT tubes. cell-free DNA (cfDNA) is isolated from double-spun plasma and assessed for the presence of KRAS codon 12, 13, 61, and 146 mutations using digital droplet PCR.(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.

5 to 10 days

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 Regional Manager. 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

81276

81479 (if appropriate for government payers)

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
KRASD cfDNA KRAS 12, 13, 61, 146 Blood 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.
113123 Result Summary 50397-9
113125 Interpretation 69047-9
113126 Additional Information 48767-8
113127 Specimen 31208-2
113128 Source 31208-2
113129 Released By 18771-6
113508 Result 75974-6

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