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KRAS Mutation Analysis, 7 Mutation Panel, Colorectal

Important Note

Test subject to Local Coverage Determination (LCD) Molecular Pathology Procedures (L35000).

Please check with the patient’s insurance to determine if prior authorization is required. Reminder- Medicare does not provider prior authorization. If in doubt about the coverage for a Medicare patient, please obtain an ABN.

Additional Codes

Primary ID

Epic Code

Mayo Test ID

KRASC1

N/A

KRASC

 

Useful For

Prognostic markers for cancer patients treated with epidermal growth factor receptor-targeted therapies

Additional Tests

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

Testing Algorithm

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

Method Name

Polymerase Chain Reaction (PCR) Analysis

Reporting Name

KRAS Mutation Analysis, Colorectal

Specimen Type

Varies


Specimen Required


Pathology report must accompany specimen in order for testing to be performed.

 

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 Minimum Volume

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.

Specimen Stability Information

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

Reject Due To

Hemolysis NA
Lipemia NA
Icterus NA
Other Specimens that have been decalcified (all methods); specimens that have not been formalin-fixed, paraffin-embedded; bone marrow in EDTA

Reference Values

An interpretative report will be provided.

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

5 days

Specimen Retention Time

Unused portions of blocks will be returned. Unused slides are stored indefinitely.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

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

 

Additional Test

88381-Microdissection, manual

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KRASC KRAS Mutation Analysis, Colorectal 85509-8

 

Result ID Test Result Name Result LOINC Value
53273 Result Summary 50397-9
53274 Result 82939-0
53275 Interpretation 69047-9
53276 Specimen 31208-2
53277 Source 31208-2
54445 Tissue ID 80398-1
53278 Released By 18771-6

NY State Approved

Yes

Forms

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

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