KRAS Mutation Detection

0040248
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Example Reports
LTB
Not Detected
Positive

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Additional Technical Information
Ordering Recommendation

Aid in treatment decisions in individuals with solid tumors including colorectal and non-small cell lung cancers. Does not cover extended RAS; detects mutations in KRAS codons 12, 13, and 61 only.

Mnemonic
KRAS
Methodology

Polymerase Chain Reaction/Pyrosequencing

Performed

DNA isolation: Sun-Sat
Assay: Mon, Wed, Fri

Reported

7-12 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Tumor tissue. Also acceptable: DNA extracted by CLIA certified lab with corresponding client-circled H&E slide.

Specimen Preparation

Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Transport tissue block or 5 unstained 5-micron slides. (Min: 3 slides) Transport block(s) and/or slide(s) in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Extracted DNA: Transport 40 uL DNA with at least 50 ng/uL concentration. (Min: 40 uL) Transport DNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Extracted DNA: Refrigerated.

Unacceptable Conditions

Less than 25 percent tumor. DNA extracted by a non-CLIA lab. DNA extracted without a corresponding circled H&E slide. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens.

Remarks

Include surgical pathology report.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerate: Indefinitely; Frozen: Indefinitely

Reference Interval
Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

This assay detects mutations in codons 12, 13, and 61.

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
08/19/2019
X
N/A
CPT Codes

88381; 81275; 81276

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Components
Component Test Code* Component Chart Name LOINC
0040249 KRAS Mutation Detection 21702-6
2002148 Block ID 57723-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • anti-EGFR therapy resistance testing
  • Cetuximab (Erbitux)
  • Codon 12,13
  • Codon 61
  • KRAS codons 12, 13, 61
  • Panitumumab (Vectibix)
  • RAS
KRAS Mutation Detection