Cancer Gene Mutation Panel for the identiﬁcation of mutations in 50 cancer-related genes uses 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, colorectal, thyroid, brain and skin cancer (melanoma)for appropriate diagnosis, prognosis and selection of therapy. The panel will also identify relevant genes that may have implications for enrollment of the patient in clinical trials. The genes interrogated in the panel are listed below:
A surgical pathology and/or cytology report and completed requisition form must accompany all specimens.
Specimen Type: Paraffin embedded tissue sections
- Tissue should be fixed in formalin and not exposed to decalcification solution. The paraffin block should contain at least a 3 mm area of tumor.
- The minimum amount of neoplastic cellularity acceptable in the tissue section is 20%.
- One H&E and 6 unstained sections are required for most of the tests. Ten unstained sections or more are required if the tissue is small. Please call the lab if you have questions.
- Slides should be properly labeled with a block label that matches the surgical pathology specimen number on the surgical pathology report.
Specimen Type: Fixed Fine Needle Aspiration (FNA) samples
- One H&E and 4-6 unstained sections from cell block are required.
- Fresh specimens should be collected into preservative solution
- Slides should be properly labeled with a number that matches the specimen number on the cytology report.
Specimen Type: Frozen tissue
- A minimum of 2 x 2 x 2 mm of frozen tissue containing at least 20% neoplastic cells is necessary
Ordering the Test
Please discuss with your oncologist whether ordering this test is right for you.
50-Gene was developed and its performance characteristics was determined by the Englander Institute for Precision Medicine/New York Hospital Laboratories. This method has not been cleared by the Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. 50-Gene may be used for clinical purpose and should not be regarded as experimental or research only.
The lack of a given genetic alteration in this report does not necessarily indicate the absence of the alteration in the tumor since technical aspects of the assay, including inadequate coverage of some genes, limit the data that can be acquired in some genetic regions. Alterations that occur in the germline are not reported. If a possible pathogenic germline mutation (inherited) is suspected, then counseling by a board certified genetic counselor will be recommended in note.