TEST:

MelaNodal Predict™

The MelaNodal Predict assay is a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay based upon the CP-GEP (clinicopathologic and gene expression profile) model that combines the gene expression of 8 target genes (MLANA, GDF15, CXCL8, LOXL4, TGFBR1, ITGB3, PLAT, SERPINE2) and two control genes (RLP0 and ACTB) with the clinicopathological features of patient age and Breslow depth to predict a cutaneous melanoma patient's risk of sentinel lymph node mestastasis from fomalin-fixed, paraffin-embedded primary tumor tissue obtained from those who are being considered for the sentinel lymph node biopsy procedure (SLNB) in accordance with current recommended SLNB eligibility to identify patients who may safely forgo the SLNB procedure due to a low risk of nodal metastasis.