NeoTYPE® DNA & RNA - Brain

NeoTYPE® DNA & RNA - Brain uses targeted next-generation sequencing (NGS) to detect single nucleotide variants, insertions/deletions, and gene fusions in 83 unique genes total (62 DNA, 28 RNA; overlapping targets included), plus microsatellite instability (MSI) and tumor mutational burden (TMB). In addition, FISH is performed to detect nine key copy number alterations and PD-L1 immunohistochemistry is performed. MGMT Promoter Methylation Analysis by PCR is an optional add-on. Results are incorporated into one report providing diagnostic, prognostic, and therapeutic implications, as well as potential clinical trial options.

A microsatellite instability 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 both DNA and RNA results, the available results will be reported and alternate CPT® Codes may apply.

SNVs/Indels (62 genes):
AKT1, APC, ATRX, BAP1, BCOR, BCORL1, BRAF, CDK6, CDKN2A, CDKN2B, CIC, CTNNB1, DICER1, EED, EGFR, EPCAM, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, FUBP1, GNA11, GNAQ, H3F3A (H3-3A), HIST1H3C (H3C3), HRAS, IDH1, IDH2, KDM6A, KRAS, MAP2K1, MET, MLH1, MSH2, MSH6, MYC, MYCN, NOTCH1, NF1, NF2, NRAS, PDGFRA, PIK3CA, PMS2, PTCH1, PTEN, RB1, SETD2, SF3B1, SMAD4, SMARCA4, SMARCB1, SMO, SRC, SUFU, SUZ12, TERT Promoter, TP53, TSC1, TSC2, and VHL

RNA Fusions (28 genes):
ALK, BRAF, CIC, EGFR including EGFRvIII, EML4, ETV6, EWSR1, FGFR1, FGFR2, FGFR3, FUS, KIAA1549, MAML2, MET, MN1, MYB, MYBL1, NTRK1, NTRK2, NTRK3, PRKCA, RAF1, ROS1, STAT6, TACC3, TFG, YAP1, and ZFTA (C11orf95)

CNVs by FISH (9 CNVs):
1p/19q co-deletion, +7/-10 (trisomy 7, monosomy 10), CDKN2A (p16) deletion, EGFR amplification, MET amplification, MYCN amplification, PDGFRA amplification, and PTEN deletion (FISH is global only)

IHC:
PD-L1 LDT (tech-only available)

Other Biomarkers:
Microsatellite Instability (MSI) and Tumor Mutation Burden (TMB) included. MGMT Promoter Methylation Analysis may be added.

As of May 12, 2025, this test serves as replacement for the following test(s) that are no longer offered:
Brain NGS Fusion Panel