ERBB2 Mutation Analysis
Alternative name:
c-ERBB2 (HER-2/neu)
Methodology
Molecular
Test Description and clinical significance
Genes
ERBB2
Disease:
Breast invasive ductal carcinoma, lung adenocarcinoma, colon adenocarcinoma, and bladder urothelial carcinoma
Molecular test that utilizes NGS technology to detect mutations in ERBB2. This gene encodes a member of the epidermal growth factor (EGF) receptor family of receptor tyrosine kinases. This protein has no ligand binding domain of its own and therefore cannot bind growth factors detected by next generation sequencing.
Specimen Requirements
Collection:
FFPE sections, 5-10 sections are recommended at 4 to 10 micron. A minimum of 20 ?l of each DNA with a concentration of at least 5ng/?l and an OD260/280 ratio of 1.7-1.9 and 2.0-2.1 respectively, obtained on a spectrophotometer is required.
Stability:
FFPE blocks- Indefinitely/ FFPE Slides-4 weeks
Unacceptable Conditions:
Specimen submitted is in the incorrect fixative. Insufficient specimen (less than 10% of tumor). Unlabeled or improperly labeled specimens. Decalcified specimens. Improperly stored DNA or RNA.
Storage & Transport
Store FFPE blocks and slides at room temperature. Genomic DNA must be stored at 2–8°C for several weeks post extraction, then at –15 to –25°C for long term storage
CPT(s)
81479
New York Approved
NO
TAT
10 Days
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
