The treatment of non-small cell lung adenocarcinoma has become more successful due to targeted treatments based on the molecular profile of a patient’s particular tumor. The Lung Cancer Mutation Analysis panel is now available for clinical testing at the Spectrum Health Advanced Technology Laboratories (ATL).
This panel is designed to follow the current National Comprehensive Cancer Network (NCCN) guidelines for non-small cell lung cancer by evaluating EGFR, ALK and other driver genetic alterations using multiplex testing. Targeted agents may be available for treatment based on the genetic alteration profile identified.
Spectrum Health ATL has run about 175 patient samples in the first 6 months after the Lung Cancer Mutation panel launched in Jun 2015. In addition to mutations detected in the EGFR and ALK genes by the previous EGFR reflex to ALK testing algorithm, this new Lung Cancer Mutation panel detected 17 other genetic alterations in BRAF, HER2, RET and MET genes during this period. These findings provided potential targeted treatments for an additional 10% of patients.
The Lung Cancer Mutation panel offered by ATL is designed to fulfill the current recommendations published by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines). These guidelines recommend testing for sequence mutations in specific regions of the EGFR, KRAS, BRAF, and HER2 (ERBB2) genes, gene rearrangements involving the ALK, ROS1 and RET genes, and amplification of the MET gene. Sequence mutations in the EGFR, KRAS, BRAF, and HER2 genes is tested using next generation sequencing by AmpliSeq™ technology on the Ion Torrent Personal Genome Machine (PGM™) in the Molecular Diagnostics laboratory. Rearrangements of the ALK, ROS1 and RET genes as well as amplification of the MET gene are detected by Fluorescence in-situ hybridization (FISH) in the Cytogenetics laboratory. Both Molecular Diagnostics and Cytogenetics laboratories are located at ATL. Ordering clinicians receive genetic alterations results of all eight genes in one comprehensive report with appropriate interpretation.
Ordering Tests
The Lung Cancer Mutation Analysis panel is composed of mutation analysis for targeted exons of EGFR, BRAF, KRAS and HER2 (ERBB2) by next generation sequencing and gene rearrangement analysis for ALK, ROS1 and RET, as well as MET amplification by FISH. This new order will replace the current order of EGFR with reflex to ALK FISH. Samples with limited tumor tissue available will be triaged and testing will be done in the following order: EGFR/KRAS/ BRAF/HER2 (multiplex testing), ALK, ROS1, MET, RET. Genes that are not tested will be noted in the results report and charges will be credited. Additionally, ALK, ROS1 and RET gene rearrangements and MET amplification by FISH will be available as stand-alone orders.
Specimen requirements are an H&E stained slide which has the tumor circled and 10 unstained 5μ slides, as well as the corresponding block. Please use the updated ATL Surgical Specimen Testing form.
Test Results
The average turnaround time of the test is 7 days (range 3-14 days), which is critical to patient care. Compared to other commercial testing options on market, the Lung Cancer Mutation panel at ATL requires less testing materials for more effective and value based testing.
To order the Lung Cancer Mutation panel test, please use these forms:
Questions can be directed to Molecular Diagnostics (486.6280) or Cytogenetics (486.6279).