Alternative Name
NGS ALK, NTRK, RET, ROS1 Fusion Profile | NGS Lung Fusion Profile
Methodology
Molecular
Test Description

The Lung NGS Fusion Profile is an RNA-based next-generation sequencing panel that detects translocations and fusions of the genes ALK, NTRK1, NTRK2, NTRK3, RET and ROS1 with known and novel fusion partners. Point mutations in select exons of these six genes are also detected. Examples of some of the published fusions detectable in this test include EML4-ALK, KIF5B-ALK, NPM1-ALK, CD74-NTRK1, MPRIP-NTRK1, TPM3-NTRK1, TRIM24-NTRK2, PAN3-NTRK2, ETV6-NTRK3, CCD6-RET (aka RET-PTC1), KIF5B-RET, NCOA4-RET (aka RET-PTC3), CD74-ROS1, SLC34A2-ROS1, and TPM3-ROS1.

This test may be used to select patients for therapy with the FDA-approved TRK inhibitor Vitrakvi® (larotrectinib).

We recommend FISH as the primary method of ALK, RET, and ROS1 rearrangement detection. We suggest using this test for NTRK analysis and/or cases that fail to provide conclusive FISH results. See also NTRK NGS Fusion Profile and NTRK & RET NGS Fusion Profile.

Clinical Significance

Fusions of the ALK, NTRK1, NTRK2, NTRK3, RET and ROS1 kinase genes with various partner genes have been reported as oncogenic drivers in multiple cancer types including lung adenocarcinoma. Chimeric proteins resulting from the gene fusions may be overexpressed or constitutively activated and lead to progression of cancer. Patients whose tumors have such gene fusions may respond to various kinase inhibitors. In non-small cell lung carcinoma (NSCLC), these gene fusions are detected with the following approximate frequencies: ALK (4-6%), NTRK (1%), RET (1-2%), and ROS1 (1-2%).

Specimen Requirements

FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Storage and Transportation

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*
81445
Turnaround Time

14-21 days

Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.