Veripath Test Directory

Synonyms Epidermal Growth Factor Receptor Mutation Analysis
EGFR Mutation Analysis in NSCLC
Description Exons 18-21(tyrosine kinase domain) by DNA Sequencing
Specimen Requirements 
Specimen Type Formalin fixed paraffin tissue on slides, FNA, Solid Tissue
Preferred Collection Volume
Minimum Collection Volume
Collection Instructions Please contact Molecular Diagnostics lab at 214-648-0960 for more instruction.
Specimen Handling NSCLC-associated tissue only. Corresponding pathologist's report must accompany specimen.

Formalin-fixed paraffin-embedded (FFPE) unstained slides: 10 unstained sections, each 10-microns thick, total >500mg tumor; corresponding H&E stained 5-micron section required; no mercury­ based (B-5) fixation; FNA cell blocks should have >50% tumor cells.

FNA specimens: unrefrigerated fresh neat, in saline, or RPMI. Specimens must be received in lab within 3 hours of collection. Refrigerated (not frozen) samples must be received in lab within 24 hours of collection. At least 10,000 tumor cells are required. Tumor cells must be >50% of specimen as predetermined by referring cytopathologist.

Solid Tissue, fresh or frozen: >500 mcg tumor. Tumor must constitute >50% of specimen as predetermined by referring pathologist. Collect in RPMI, saline, or neat. Fresh specimens must be received in lab within 3 hours of collection. Frozen specimens must be received in lab within 72 hours of collection, ship on dry ice.
Rejection Criteria Mercury-based fixative (B-5) FFPE specimens. Unstained FFPE sections without corresponding H&E section. Fresh FNA or solid tissue received in water. Heparinized specimens. Frozen FNA cells.
Methodology PCR and Sanger DNA Sequencing
Reference Range No Mutation Detected
CPT Code(s) 81235, (88381 or 88387)
Department Molecular Diagnostics
Contact Information Lab: (214)-648-0960
Turn Around TimeInternal Cases: <14 days from order or biopsy date, whichever is later; External Cases: <7 days from order date or receipt of unstained slides, whichever is later.
Performed As requested
Performed by Molecular Diagnostics
Updated/Reviewed 12/07/2016