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Test Code BRAFD BRAF V600E/V600K Somatic Mutation Analysis, Tumor

Reporting Name

BRAF V600 Somatic Mutation Analysis, Tumor

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Therapy selection for patients with cancer (eg, melanomas that may respond to BRAF inhibitors, colon cancers that may not respond to EGFR inhibitors)

 

Aiding in the diagnosis/prognosis of certain cancers (eg, hairy cell leukemia, papillary thyroid cancers, and association with aggressiveness)

 

Aiding in determining risk for Lynch syndrome (eg, an adjunct to negative MLH1 germline testing in cases where colon tumor demonstrates MSI-H and loss of MLH1 protein expression)

 

This test is not intended as a screening test to identify cancer.

Method Name

Droplet Digital Polymerase Chain Reaction (ddPCR)


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

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

-Date of tissue collection

-Source of the tissue



Specimen Required


Preferred:

Specimen Type: Tissue block

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

 

Acceptable:

Specimen Type: Tissue slide

Slides: 1 Hematoxylin and eosin 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

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reject Due To

Specimens that have been decalcified (all methods)
Specimens that have not been formalin-fixed, paraffin-embedded
Bone marrow in EDTA
Reject

Reference Values

An interpretive report will be provided.

Interpretation

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

Day(s) Performed

Varies

Report Available

6 to 12 days

Test Classification

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

81210

88381-Microdissection, manual

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BRAFD BRAF V600 Somatic Mutation Analysis, Tumor 97025-1

 

Result ID Test Result Name Result LOINC Value
608306 Result Summary 50397-9
608307 Result 97025-1
608308 Interpretation 69047-9
608309 Additional Information 48767-8
608310 Specimen 31208-2
608311 Source 31208-2
608312 Released By 18771-6
608235 Method 85069-3
608222 Tissue ID 80398-1
606746 Disclaimer 62364-5

Forms

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

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.

 

For more information see Lynch Syndrome Testing Algorithm.

Special Instructions