Clinical Significance:
Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a primary resection available for testing.  The presence of BRAF V600E mutation has been associated with responsiveness to combined therapy with oral inhibitors of BRAF and MEK.  Other mutations have been observed in NSCLC; however, the clinical significance is has not been well-characterized. 

Specimen Requirements and Collection:
Formalin-fixed tissue containing a sufficient amount of tumor (generally at least several mm of tumor tissue submitted in the tissue block)

Methodology:
DNA isolation and extraction, library prep, and next-generation sequencing (NGS)

Forms:
Molecular pathology requisition form

Transport:
Send formalin-fixed, paraffin-embedded (FFPE) tissue and cell block containing tumor at room temperature.  Also acceptable 10-unstained, 4-5 micron slides with 1 post H&E.  Please include a surgical pathology report

Unacceptable specimen:
Specimens fixed in alternative fixatives or metal fixatives (ex. B-plus).  Decalcified specimens.

Reference Range:
BRAF V600E mutation not detected = negative result
BRAF V600E mutation detected = positive result

CPT codes:
88381, 81210, G0452

Test reported:
Results are reported within 7-10 days