This cancer gene mutation panel for the identiﬁcation of mutations in 50 cancer-related genes utilizes targeted Next-Generation Sequencing (NGS) and the Ion AmpliSeq Cancer Hot Spot Panel v2 by Ion Torrent (Life Technologies). The panel facilitates the detection of actionable and targetable mutations in lung, colon, rectum, thyroid, brain and skin cancer for appropriate diagnosis, prognosis and selection of therapy.
One Hematoxylin and Eosin (H&E) and six unstained sections are required for most tests. 10 unstained sections or more are required if the tissue is small. Neoplastic content should be greater than 20 percent. A surgical pathology and/or cytology report and completed requisition form must accompany all specimens.
50-Gene was developed and tested in Englander Institute for Precision Medicine (EIPM) and NewYork-Presbyterian (NYP) Hospital laboratories. 50-Gene has not been approved by the Food and Drug Administration (FDA). The FDA has determined that such approval is not necessary. 50-Gene may be used for clinical purposes and should not be regarded as only experimental or investigative. The lack of a given genetic alteration in this report does not necessarily indicate the absence of the alteration in a tumor, as technical aspects of the assay, including inadequate coverage of specific genes, limit the data that can be acquired in certain genetic regions. Alterations that occur in the germ line are not reported. If a possible pathogenic (inherited) germ line mutation is suspected, counseling from a board-certified genetic counselor will be recommended.