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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. A microsatellite instability (MSI) NGS result of "indeterminate" will create a reflex to MSI by PCR as long as the tumor percentage is ≥40% 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. SNVs/Indels/CNVs (44 genes): AKT1, ALK, ARAF, ARID1A, ATM, ATR, ATRX, BRAF, CDKN2A, CDKN2B, EGFR, ERBB2*, ERBB3, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, KEAP1, KIT, KMT2D, 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. RNA Fusions (19 genes): 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. IHC: PD-L1 22C3 FDA for NSCLC (tech-only available) Other Markers: Microsatellite Instability (MSI) and Tumor Mutation Burden (TMB) included.
Level of Service
A block is preferred for testing: >20% tumor and >10 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.
Storage & 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.
81445x1. Add 88360x1 for PD-L1 IHC.
*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.
Last Updated: January 22, 2025