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Beaumont Laboratory

BRAF Mutation Analysis in Metastatic Colon Cancer and Non-Small Cell Lung Cancer

BRAF, colon cancer, melanoma, papillary thyroid, non-small cell lung cancer, V600E, SOFTPATH: MBRFG, SOFTLAB: MBRFG, SOFTMOL: MBRF

Specimen Collection Criteria

Collect: Paraffin-embedded tissue. A paraffin block must be submitted. (Slides or paraffin shavings are not acceptable.) Submit formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue should be well fixed and well processed. Average tissue size 5.0 mm2.

  • DNA will be assessed for quality. If it is deemed unacceptable, testing will be cancelled with client notification.
  • The specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, and source of specimen. 

Physician Office/Drawsite Specimen Preparation

Maintain paraffin-embedded tissue at room temperature (20-26°C or 68-78.8°F) until transport.

Preparation for Courier Transport

Transport: Paraffin-embedded tissue, at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

  • Decalcified tissue.
  • Fixatives other than 10% neutral buffered formalin.
  • Specimens fixed/processed in alternative fixatives (e.g. alcohol, zinc formalin).
  • Improper labeling or inadequate information. 
  • Less than 10 percent tumor cellularity, at discretion of medical director.
  • Poor quality and/or quantity of extracted genomic DNA.

Testing will be cancelled on specimens meeting the above criteria with client notification


Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Room Temperature (20-26°C or 68-78.8°F): 7 days


Royal Oak Clinical Molecular Pathology Laboratory.


Once per week, usually Wednesday.
Results available in 10 business days.

Reference Range

No BRAF mutations detected.

Test Methodology

Tissue sections are reviewed by a pathologist and relevent tumor is selected for analysis. DNA is isolated from the sample and quantified. The DNA is amplified using reagents supplied in a BRAF mutation detection kit (EntroGen, Inc., Tarzana CA). The samples are analyzed using an ABI 7500 FAST Real-Time PCR Instrument (Applied Biosystems Inc, Foster City, CA). False positive or negative results may occur for reasons that include genetic variants or somatic heterogeneity of the tissue sample.


--Negative; No BRAF mutation detected.

--Positive; BRAF V600 mutation(s) detected.

Clinical Utility

  • The BRAF Mutation Analysis Assay provides additional guidance in therapeutic treatment decisions for patients with metastatic colorectal adenocarcinoma, non-small lung cancer (NSCLC), malignant melanoma, and papillary thyroid carcinoma.
  • Mutations in the BRAF gene, a known downstream signaling molecule in the EGFR signaling pathway, have been described in approximately 15-30% of lung adenocarcinoma, 30-50% of colorectal adenocarcinoma, 37-50% of malignant melanoma, and 40-45% of papillary thyroid carcinoma.
  • Recent studies have shown that NSCLC and malignant melanoma positive for the BRAF V600E mutation are responsive to targeted therapeutic agents. In addition, the presence of BRAF V600 mutations may have other prognostic and therapeutic implications in colorectal and papillary thyroid carcinoma.

CPT Code


Last Updated


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UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.

This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.