Code
NTG-DRLX-02CX
Profile
Active-Compendium
81459x1. Add 88360x1 for PD-L1 IHC.
81479x1. If sample is insufficient to produce RNA fusion results but DNA SNV/indel and/or CNV results are reported, 81479x1 still applies. If only RNA fusion results are reported, use 81445x1 instead. Add 88360x1 for PD-L1 IHC.
Clinical
Oncology,Pathology
<p>A block is preferred for testing: >20% tumor and >5 mm2 of tissue surface area for NGS (~500 tumor cells)(additional 100 neoplastic cells for PD-L1). If submitting 5-micron unstained slides, the following number of slides are requested: Samples with >25 mm2 of tissue: 10 unstained slides (2 sections per slide preferred) Samples with 10-24 mm2 of tissue: 20 unstained slides (2 sections per slide preferred) Please submit 1 additional unstained slide for H&E and 3 additional unstained slides if performing PD-L1 testing.</p>
Flag Active
True
Orderable Test Description
<p>NeoTYPE® DNA & RNA - Lung is a targeted next-generation sequencing profile that detects single nucleotide variants (SNV), insertions/deletions (InDels), copy number variants (CNV), and RNA fusions and splice variants in a total of 50 genes (44 genes analyzed by DNA and 19 by RNA), plus microsatellite instability (MSI) and tumor mutation burden (TMB). PD-L1 immunohistochemistry is optional. Results are summarized and details provided for prognostic findings, therapy susceptibility or resistance, available clinical trials, and more.<br><br>
A microsatellite instability (MSI) NGS result of "indeterminate" will create a reflex to MSI by PCR as long as the tumor percentage is ≥20% and paired normal tissue is available. If the sample is insufficient to produce either DNA or RNA results, the available results will be reported and alternate CPT® Codes may apply.<br><br>
SNVs/Indels/CNVs (44 genes):<br>
AKT1, ALK, ARAF, ARID1A, ATM, ATR, ATRX, BRAF, CDKN2A, CDKN2B, EGFR, ERBB2*, ERBB3, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, KEAP1, KIT, KRAS, MAP2K1, MET*, NF1, NFE2L2, NOTCH1, NRAS, NTRK1, NTRK3, PDGFRA, PIK3CA, PTEN, RB1, RBM10, RET, ROS1, SMAD4, SMARCA4, SMO, STK11, TERT Promoter, and TP53* CNV detection in addition to SNVs and indels. The full coding sequence of each DNA gene is tested.<br><br>
RNA Fusions (19 genes):<br>
ALK, BRAF, FGFR1, FGFR2, FGFR3, FGFR4, MET** including METex14 skipping, NOTCH1, NOTCH2, NRG1, NTRK1, NTRK2, NTRK3, PDGFB, PDGFRA, PDGFRB, RAF1, RET, ROS1 ** Splice variant detection in addition to fusions. The full coding sequence of each RNA gene is tested.<br><br>
IHC:<br>
PD-L1 22C3 FDA for NSCLC (tech-only available)<br><br>
Other Markers:<br>
Microsatellite Instability (MSI) and Tumor Mutation Burden (TMB) included.</p>
A microsatellite instability (MSI) NGS result of "indeterminate" will create a reflex to MSI by PCR as long as the tumor percentage is ≥20% and paired normal tissue is available. If the sample is insufficient to produce either DNA or RNA results, the available results will be reported and alternate CPT® Codes may apply.<br><br>
SNVs/Indels/CNVs (44 genes):<br>
AKT1, ALK, ARAF, ARID1A, ATM, ATR, ATRX, BRAF, CDKN2A, CDKN2B, EGFR, ERBB2*, ERBB3, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, KEAP1, KIT, KRAS, MAP2K1, MET*, NF1, NFE2L2, NOTCH1, NRAS, NTRK1, NTRK3, PDGFRA, PIK3CA, PTEN, RB1, RBM10, RET, ROS1, SMAD4, SMARCA4, SMO, STK11, TERT Promoter, and TP53* CNV detection in addition to SNVs and indels. The full coding sequence of each DNA gene is tested.<br><br>
RNA Fusions (19 genes):<br>
ALK, BRAF, FGFR1, FGFR2, FGFR3, FGFR4, MET** including METex14 skipping, NOTCH1, NOTCH2, NRG1, NTRK1, NTRK2, NTRK3, PDGFB, PDGFRA, PDGFRB, RAF1, RET, ROS1 ** Splice variant detection in addition to fusions. The full coding sequence of each RNA gene is tested.<br><br>
IHC:<br>
PD-L1 22C3 FDA for NSCLC (tech-only available)<br><br>
Other Markers:<br>
Microsatellite Instability (MSI) and Tumor Mutation Burden (TMB) included.</p>
Orderable Turn Around Time
8-10 Days
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"RNA Sequencing": {"Fusions": ["MET", "RAF1", "ROS1", "FGFR2", "NOTCH1", "FGFR4", "NRG1", "PDGFB", "NOTCH2", "RET", "FGFR1", "NTRK1", "NTRK2", "NTRK3", "PDGFRA", "PDGFRB", "ALK", "BRAF", "FGFR3"]}, "DNA Sequencing": {"SNVs + Indels": ["KIT", "KRAS", "KEAP1", "NRAS", "NOTCH1", "FBXW7", "MAP2K1", "STK11", "ATRX", "ALK", "ARAF", "NF1", "NFE2L2", "CDKN2B", "RB1", "RBM10", "RET", "CDKN2A", "ROS1", "TERT", "AKT1", "ARID1A", "ATM", "FGFR2", "FGFR3", "SMARCA4", "ATR", "ERBB3", "EGFR", "ERBB2", "ERBB4", "FGFR4", "NTRK1", "FGFR1", "MET", "SMO", "NTRK3", "PDGFRA", "PIK3CA", "PTEN", "SMAD4", "TP53", "BRAF"], "Genomic Signatures": ["MSI", "TMB"]}}
Keywords string
DNA & RNA Lung, Lung DNA & RNA, Lung 2.0, DNA and RNA, Non-small cell lung cancer NeoTYPE® DNA & RNA - Lung
Title URL
neotype-dna-rna-lung
TAT Details
NGS: 8-10 Days
IHC: 2 Days
Storage and transportation
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.