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NeoTYPE DNA ; RNA Lung (plus PD-L1)

Message
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

 


Test Code
LAB6587


CPT Codes
81445x1. Add 88360x1 for PD-L1 IHC

Preferred Specimen
FFPE Tissue:  Paraffin block preferred.   Please use 10% buffered formalin fixative.  Do not use zinc fixatives.


Minimum Volume
Minimum surface area 10mm2 with ≥20% tumor content. 


Other Acceptable Specimens
Send ≥10 unstained sections on positively charged sides cut at 5 microns plus one H&E slide (which NeoGenomics will keep). Add 3 slides if ordering PD-L1 IHC.


Instructions
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.


Methodology
Molecular

Report Available
10 Days


Clinical Significance
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.


Performing Laboratory
Neogenomics Laboratories



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.