CC-SIGN® NTRK Plus Gene Fusion NGS Panel
CC-SIGN® NTRK Plus Gene Fusion NGS Panel is a laboratory developed test designed to detect fusion events in NTRK1, NTRK2, and NTRK3, regardless of fusion partner.
The US Food and Drug Administration has recently approved the use of larotrectinib (Vitrakvi®) to treat patients whose tumors harbor NTRK1, NTRK2, or NTRK3 fusions. Clinical information obtained from CC-SIGN® NTRK Plus Gene Fusion NGS Panel can determine if a patient is a candidate for treatment.
Expert Consultation Services
• Consultation with expert pathologists is available when necessary or desired.
• A concise, in-depth report is provided for each case.
• Results within 14 days of specimen receipt.
What Is Larotrectinib?
Larotrectinib is a drug utilized for the treatment of solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.1 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.
Genes Involved in Fusions Interrogated in this Test
A specimen positive for a fusion in one of these three genes makes the patient a candidate for larotrectinib treatment.
• Ten (10) unstained, 4 µM sections of formalin-fixed, paraffin-embedded (FFPE) tissue 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)
This test is intended for determining NTRK gene fusion status to identify candidates for larotrectinib treatment.
The NTRK Plus Gene Fusion NGS Panel interrogates for fusions involving 34 genes, including NTRK1, NTRK2, and NTRK3. Given their potential clinical relevance, results for all tested genes are reported.
This test does not detect single nucleotide variants; some data show acquired kinase domain resistance mutations that are not interrogated by this test.
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