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 ≥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:
- 10 unstained slides (2 sections per slide preferred) plus 1 additional unstained slide for H&E and 3 additional unstained slides for PD-L1 testing.
- Samples from cell block, FNAs, small needle core biopsies: 20 unstained slides (2 sections per slide preferred) plus 1 additional unstained slide for H&E and 3 additional unstained slides for PD-L1.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.
8-10 days*
*Published Turnaround time (TAT) begins from sample receipt at one of our NeoGenomics laboratories. Additional time (beyond published TAT) may be needed for New York state clients where findings require fusion confirmation testing per regulatory guidelines.