CC-SIGN® NTRK Gene Fusion Next-Generation Sequencing Panel
This NGS-based laboratory-developed test is designed to detect fusion events in NTRK1, NTRK2, and NTRK3, regardless of fusion partner.
Clinical information obtained from the CC-SIGN® NTRK Gene Fusion NGS Panel can determine if a patient is a candidate for TRK tyrosine kinase inhibitor treatment.
The US Food and Drug Administration (FDA) has approved the use of first-generation TRK tyrosine kinase inhibitors—including larotrectinib (Vitrakvi®) and entrectinib (Rozlytrek®)—to treat patients whose tumors harbor NTRK1, NTRK2, or NTRK3 fusions.
NTRK Fusions are Clinically Actionable
TRK tyrosine kinase inhibitors, such as larotrectinib and entrectinib, are drugs utilized to treat solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. These drugs provide a treatment option to patients with no satisfactory alternative therapies or whose cancer has progressed following treatment, specifically in cases that are either metastatic or where surgical resection is likely to result in severe morbidity.1,2 This treatment targets cancers with NTRK fusions and is not limited by tissue or tumor type.
1. U.S. Food & Drug Administration. FDA approves larotrectinib for solid tumors with NTRK gene fusions. Available at https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626720.htm. [Online] Updated Dec 17, 2018.
2. U.S. Food & Drug Administration. FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC. Available at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinibntrk-solid-tumors-and-ros-1-nsclc [Online] Updated Aug 16, 2019.
14 days (upon specimen receipt)
Ten (10) unstained, 4 µM sections of formalin-fixed, paraffin-embedded (FFPE) on charged, unbaked slides
One H&E stained slide with best tumor area circled by a pathologist (minimum of 20% tumor content for best results)
Room (ambient) temperature
Specimen Mailing Address
Cleveland Clinic Laboratories
2119 E. 93rd Street, L15
Cleveland, OH 44106
This test is intended for determining NTRK gene fusion status to identify candidates for larotrectinib treatment.
This test does not detect single nucleotide variants; some data show acquired kinase domain resistance mutations that are not interrogated by this test.
Exons 2, 4, 6, 8, 10-14
Exons 5, 7, 9, 11-18
Exons 4, 7, 10, 12-16