BRAF Codon 600 Mutation Detection with Reflex to MLH1 Promoter Methylation

0051750
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Example Reports
Not Detected
Positive

Ordering Recommendation

Recommended reflex test to differentiate between Lynch syndrome and sporadic colorectal cancer in tumors showing loss of MLH1.

Mnemonic

BRAF RFLX

Methodology

Polymerase Chain Reaction/Pyrosequencing

Performed

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

Reported

5-10 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Tumor tissue.

Specimen Preparation

Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Tissue block will be returned after testing. Transport tissue block or 5 unstained 5 micron slides. (Min: 3 slides). Transport block 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.

Storage/Transport Temperature

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

Unacceptable Conditions

Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens.

Remarks

Include surgical pathology report.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reference Interval

Test Number
 Components
 Reference Interval
  BRAF codon 600 Mutation Detection By report
  MLH1 Promoter Methylation By report

Interpretive Data

Refer to report.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

If BRAF codon 600 Mutation Detection is negative, then MLH1 Promoter Methylation will be added. Additional charges apply. 
For billing requirements, BRAF Bill will be added separately. Additional charges apply.

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
01/03/2022
X
11/15/2021
X
X
N/A

CPT Codes

88381; add 81210; If reflexed, add 81288

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Components

Component Test Code* Component Chart Name LOINC
0051751 BRAF codon 600 Mutation Detection 58415-1
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

  • BRAF Gene Mutation Assay
  • EGFR targeted therapy
  • MLH1
  • sporadic Lynch Syndrome
  • V600E
BRAF Codon 600 Mutation Detection with Reflex to MLH1 Promoter Methylation