Oncomine is a targeted Next-Generation Sequencing (NGS) test for the identification of clinically significant somatic mutations, including Single Nucleotide Variants (SNVs), insertions and deletions (indels), gene fusions and Copy Number Alterations (CNAs), from the DNA and RNA of 143 cancer-related genes (greater than 2,500 amplicons) in solid tumors. Genes examined in the assay are categorized by genomic alteration into 73 hot-spot gene categories (with SNVs and indels), including 49 genes with focal CNAs, such as ERBB2, and 23 genes with known fusions, such as ALK and ROS1 in NSCLC. The test also includes four pairs of “5’/3’” expression imbalance assays for ALK, ROS1, RET and NTRK1. In addition, the test provides full coverage of 26 tumor suppressor genes.
A surgical pathology and/or cytology report and completed requisition form must accompany all specimens.
One Hematoxylin and Eosin (H&E) slide and 15-20 unstained sections with a minimum of 20-percent neoplastic cellularity
One H&E slide and 15-20 unstained cell block sections with a minimum of 20-percent neoplastic cellularity
Cells suspended in CytoLyt or PreservCyt solution, preserved at room temperature no longer than eight days
Oncomine was developed and tested by the Weill Cornell Medicine Clinical Genomics Laboratory, Englander Institute for Precision Medicine (EIPM) and Department of Pathology & Laboratory Medicine and approved by the New York State Department of Health (NYSDOH). Oncomine has not been approved by the Food and Drug Administration (FDA). The FDA has determined that such approval is not necessary. Variants of uncertain origin (germ-line versus somatic origin) cannot be determined unequivocally with this test. If a possible pathogenic (inherited) germ line mutation is suspected, counseling from a board-certified genetic counselor will be recommended.