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.
NeoTYPE® DNA & RNA - Lung detects genomic alterations that are most relevant to therapy selection, prognosis, and clinical trial options in non-small cell lung cancer. It is appropriate for patients with newly diagnosed, recurrent, or resistant disease.
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.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.
8-10 days