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BRAF V600 Mutation Analysis

Test ID: M BRAF CPT Code: 81210

Expected Turnaround Time
14 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
Utilized as an independent predictor of colorectal cancer (CRC) patient responsiveness to EGFR inhibitor therapy and to assist with the differentiation of microsatellite instability high (MSI-H) hereditary non-polyposis colon cancer (HNPCC) from sporadic cancer.

Requisition Forms

Specimen Requirements


Specimen Requirements
  • Paraffin Embedded Tissue Block: FFPE Block, 10% NBF Fixed
  • Paraffin Embedded Tissue Slides: 5 slides or scrolls (minimum 5-10 μM), 10% NBF Fixed

Specimen Stability

Indefinite


Storage Requirements

15°C to 25°C


Shipping Conditions
Ambient

Shipping Recommendations

AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.


Specimen Rejection Criteria

Improper specimen labeling; Insufficient tissue; Insufficient tumor burden; Insufficient DNA isolated


Test Details


Synonyms

EGFR inhibitor response


Keywords
Companion Diagnostics, Molecular Diagnostics, Oncology, Mutation Analysis, DNA Sequencing, Gastrointestinal Cancer, Melanoma, Head and Neck, or Anal Cancer, Lung Cancer, Genomics, Next Generation Sequencing

Test Method
Next Generation Sequencing (NGS)

Methodology Category
Molecular

Regulatory Status
RUO

Special Considerations
  • FFPE block preferred; unbaked slides acceptable.
  • Include a surgical pathology report with the sample

Associations

Colorectal cancer (CRC), hereditary non-polyposis colon cancer (HNPCC), metastatic melanoma, papillary thyroid carcinoma; BRAF Mutation in Melanoma