Identifying solid tumors that may respond to targeted therapies by assessing multiple gene targets simultaneously
Identifying specific variants within genes known to be associated with response or resistance to specific cancer therapies
Identifying variants that may help determine prognosis for patients with solid tumors
Assisting in establishing a diagnosis (eg, KIT and PDGFRA alterations for gastrointestinal stromal tumors)
Aiding in the determination of clinical trial eligibility for patients with genetic variants not amenable to current FDA-approved targeted therapies
This test is not intended for use for hematological malignancies or assessment of germline variants
This test uses targeted next-generation sequencing to evaluate for somatic variants within 50 genes associated with cancer: ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, and VHL.
See Targeted Gene Regions Interrogated by Solid Tumor Targeted Cancer Gene Panel by Next-Generation Sequencing for details regarding the targeted gene regions identified by this test.
Test Id | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
SLIRV | Slide Review in MG | No, (Bill Only) | Yes |
When this test is ordered, slide review will always be performed at an additional charge.
Polymerase Chain Reaction (PCR)-Based Next-Generation Sequencing
CANCP
CAPN
Oncology panel
Tumor panel
Next Gen Sequencing Test
PIK3CA
When this test is ordered, slide review will always be performed at an additional charge.
Varies
Multiple oncology (cancer) gene panels are available. For more information see Oncology Somatic NGS Testing Guide.
Pathology report (final or preliminary), at minimum containing the following information, must accompany specimen in order for testing to be performed:
1. Patient name
2. Block number-must be on all blocks, slides and paperwork (can be handwritten on the paperwork)
3. Tissue collection date
4. Source of the tissue
This assay requires at least 20% tumor nuclei.
-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue144 mm(2)
-Minimum amount of tumor area: tissue 36 mm(2).
-These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei.
-Tissue fixation: 10% neutral buffered formalin, not decalcified
-For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing. In this document, the sizes are given as 4 mm x 4 mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3 mm x 1 mm x 10 slides: approximate/equivalent to 36 mm(2).
Preferred:
Specimen Type: Tissue block
Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.
Acceptable:
Specimen Type: Tissue slide
Slides: 1 Stained and 10 unstained
Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.
Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.
Specimen Type: Cytology slide (direct smears or ThinPrep)
Slides: 1 to 3 slides
Collection Instructions: Submit 1 to 3 slides stained and cover slipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells.
Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.
Additional Information: Cytology slides will not be returned.
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
See Specimen Required
Specimens that have been decalcified (all methods) Specimens that have not been formalin-fixed, paraffin-embedded | Reject |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Ambient (preferred) | ||
Frozen | |||
Refrigerated |
Identifying solid tumors that may respond to targeted therapies by assessing multiple gene targets simultaneously
Identifying specific variants within genes known to be associated with response or resistance to specific cancer therapies
Identifying variants that may help determine prognosis for patients with solid tumors
Assisting in establishing a diagnosis (eg, KIT and PDGFRA alterations for gastrointestinal stromal tumors)
Aiding in the determination of clinical trial eligibility for patients with genetic variants not amenable to current FDA-approved targeted therapies
This test is not intended for use for hematological malignancies or assessment of germline variants
This test uses targeted next-generation sequencing to evaluate for somatic variants within 50 genes associated with cancer: ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, and VHL.
See Targeted Gene Regions Interrogated by Solid Tumor Targeted Cancer Gene Panel by Next-Generation Sequencing for details regarding the targeted gene regions identified by this test.
When this test is ordered, slide review will always be performed at an additional charge.
Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the FDA for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.
Next-generation sequencing has recently emerged as an accurate, cost-effective method to identify variants across numerous genes known to be associated with response or resistance to specific targeted therapies. This test is a single assay that uses formalin-fixed paraffin-embedded tissue to assess for common variants in 50 genes known to be associated with cancer.
See Targeted Gene Regions Interrogated by Solid Tumor Targeted Cancer Gene Panel by Next-Generation Sequencing for details regarding the targeted gene regions identified by this test.
An interpretive report will be provided.
An interpretive report will be provided.
This test cannot differentiate between somatic and germline alterations. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk.
DNA variants of uncertain significance may be identified.
A negative (wildtype) result does not rule out the presence of a variant that may be present but below the limits of detection of this assay (approximately 5%-10%).
This test does not detect genomic copy number variants or large single or multi-exon deletions or duplications.
Rare alterations (ie, polymorphisms) may be present that could lead to false-negative or false-positive results. Test results should be interpreted in the context of clinical findings, tumor sampling, and other laboratory data. If results obtained do not match other clinical or laboratory findings, contact the laboratory for an updated interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.
1. Targeted Cancer Therapies. National Cancer Institute Fact Sheet. Updated April 27, 2022. Accessed May 3, 2022. Available at www.cancer.gov/cancertopics/factsheet/Therapy/targeted
2. Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz Jr LA, Kinzler KW: Cancer genome landscapes. Science. 2013 Mar;339(6127):1546-1558. doi: 10.1126/science.1235122
3. Beadling C, Neff TL, Heinrich MC, et al: Combining highly multiplexed PCR with semiconductor-based sequencing for rapid cancer genotyping. J Mol Diagn. 2013 Mar;15(2):171-176. doi: 10.1016/j.jmoldx.2012.09.003
Next-generation sequencing is performed to test for the presence of a mutation in targeted regions of 50 genes. See Targeted Gene Regions Interrogated by Solid Tumor-Targeted Cancer Gene Panel by Next Generation Sequencing for details regarding the targeted gene regions identified by this test.(Unpublished Mayo method)
Genes analyzed: ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, and VHL
Monday through Friday
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
81445-Targeted genomic sequence analysis panel, solid organ neoplasm
88381-Microdissection, manual
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
CAPN | Solid Tumor Targeted Cancer Panel | 73977-1 |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
52611 | Result Summary | 50397-9 |
52612 | Result | 82939-0 |
52613 | Interpretation | 69047-9 |
52614 | Additional Information | 48767-8 |
52615 | Specimen | 31208-2 |
52616 | Source | 31208-2 |
52617 | Tissue ID | 80398-1 |
52618 | Released By | 18771-6 |