ALK Mutation Analysis
Methodology
Molecular
Test Description and clinical significance
Genes
ALK
Disease:
Anaplastic large cell lymphomas, Neuroblastoma, and Non-small cell lung cancer
Molecular test that utilizes NGS technology to detect mutations in ALK. At least 16 mutations in the ALK gene have been identified in some people with neuroblastoma , at least 15 translocations involving the ALK gene have been identified in people with anaplastic large cell lymphoma (ALCL). It has been also found that group of people with non-small cell lung cancer have an inversion of chromosome 2. This inversion fuses the ALK gene with another gene called EML4 and results in the EML4-ALK fusion protein.
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)
81401
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.
