- Using targeted next-generation sequencing to identify lung tumors that may respond to targeted therapies by assessing somatic mutations simultaneously within EGFR, BRAF, KRAS, HRAS, NRAS, ALK, ERBB2 and MET and identifying rearrangements (fusions) involving ALK, ROS1, RET, and NTRK1.
- Diagnosis and management of patients with lung cancer
Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the FDA for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.
Next-generation sequencing has recently emerged as an accurate, cost-effective method to identify alterations across numerous genes known to be associated with response or resistance to specific targeted therapies. This is a single assay that uses formalin-fixed paraffin-embedded tissue or cytology slides to assess for common somatic mutations and rearrangements (fusions) involving 11 genes known to be associated with lung cancer. The results of this test can be useful for assessing prognosis and guiding treatment of individuals with lung tumors. These data can also be used to help determine clinical trial eligibility for patients with alterations in genes not amenable to current FDA-approved targeted therapies.
- Formalin-fixed, paraffin-embedded tissue block
- Slides: 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue
- Direct smears or ThinPrep cytology slides: 1 to 2 slides (stained and coverslipped) with a minimum of 5000 total nucleated cells
- Polymerase Chain Reaction (PCR)-Based Next Generation Sequencing
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Day(s) and Time(s) Test Performed
- Monday through Friday; Varies
- 12 days