TruSight Oncology 500 is a hybridization-capture-based Next-Generation Sequencing (NGS) assay which covers 523 cancer-related genes. DNA sequencing of the entire coding region is performed for the identification single nucleotide variants (SNVs), insertions and deletions (indels), and copy number alterations (CNAs), along with the molecular biomarkers tumor mutation burden (TMB) and microsatellite instability (MSI). RNA sequencing is also performed for 55 genes for the detection of oncogenic fusion sin a fusion-partner agnostic manner.
Formalin-fixed paraffin embedded tissue: One Hematoxylin and Eosin (H&E) slide and 15-20 unstained sections with a minimum of 20-percent neoplastic cellularity
Formalin-fixed cytology cell block: One H&E slide and 15-20 unstained cell block sections with a minimum of 20-percent neoplastic cellularity
Fine needle aspiration specimen: Cells suspended in CytoLyt or PreservCyt solution, preserved at room temperature no longer than eight days