Veripath Test Directory

Epic Test Name HER 2 MUTATION ANALYSIS
Components
Synonyms ERBB2, HER2
Description Exon 19,20 Mutations
Specimen Requirements 
Container
Specimen Type Formalin fixed paraffin tissue on slides, whole blood
Preferred Collection Volume 10-micron unstained section, 10 slides
Minimum Collection Volume
Collection Instructions Please contact Molecular Diagnostics lab at 214-648-0960 for more instruction.
Specimen Handling Corresponding pathologist's report must accompany specimen. Formalin-fixed paraffin-embedded (FFPE) unstained slides: 10 unstained sections, each 10-microns thick, corresponding H&E stained 5-micron section required; no mercury¬ based (B-5) fixation; FNA cell blocks should have >25% tumor cells.

Whole blood: ACD yellow top tube is preferred or EDTA purple top tube is acceptable. Fresh specimens must be received in lab within 2 days of collection. Refrigerated (not frozen) samples must be received in lab within 3 days of collection. At least 20% tumor cells are required.
Rejection Criteria Mercury-based fixative (B-5) FFPE specimens. Unstained FFPE sections without corresponding H&E section. Heparinized specimens. FFPE with low % tumor cells. Decalcified bone tissue
Methodology DNA Sequencing and Mass Spectrometry by Sequenom
Reference Range No Mutation Detected
CPT Code(s) 81403, (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
Link
Notes
Updated/Reviewed 12/07/2016


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