The NeoTYPE Thyroid Tumor Profile analyzes 32 biomarkers through a combination of next-generation sequencing (NGS), FISH, and IHC as listed below. Test orders include summary interpretation of all results to help guide treatment decisions. If Pan-TRK IHC is expressed or equivocal, reflex to either NTRK NGS Fusion Panel (Default) or NTRK 1-3 FISH Panel will be added. 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.
NGS (26 genes + 2 biomarkers): AKT1, ALK, ARID1A, ATM, BRAF, CDKN2A, CTNNB1, ERBB2, ERBB4, HRAS, KRAS, MEN1, MET, Microsatellite Instability (MSI), NF1, NF2, NRAS, PIK3CA, PTEN, RET, SMAD4, SMO, SRC, TERT Promoter, TP53, TSC1, TSC2, Tumor Mutation Burden (TMB)
FISH (2 FISH): MET, RET (tech-only available)
IHC (2 biomarkers): PD-L1 LDT, Pan-TRK (tech-only available for PD-L1)
The NeoTYPE Thyroid Profile is useful to classify fine needle aspirates of thyroid nodules that are indeterminate or suspicious on cytology. Presence of mutations or gene rearrangements as detected by FISH predicts malignancy with varying degrees of specificity depending on the gene mutated and histological subtype. BRAF mutation V600E is associated with poor prognosis in papillary thyroid carcinoma (PTC).
- FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature.