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MayoComplete Solid Tumor Panel
Clinical Genetic Test
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offered by
Mayo Clinic Laboratories
View lab's test page
LinkOut
GTR Test Accession: Help GTR000597215.1
CAP
Last updated in GTR: 2021-12-07
View version history
Last annual review date for the lab: 2023-05-30 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Conditions (1): Help
Solid tumor
Genes (476): Help
ABL1 (9q34.12), ABL2 (1q25.2), ABRAXAS1 (4q21.23), ACVR1 (2q24.1), ACVR1B (12q13.13), ...
Methods (3): Help
Molecular Genetics - Microsatellite instability testing (MSI): Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients with solid tumors that would benefit from biomarker-assisted management
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Mayo Clinic Laboratories
View lab's website
View lab's test page
Test short name: Help
MCSTP
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Dentist
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Public Health Mandate
  • Registered Nurse
Lab contact: Help
Antonina Wojcik, MS, Certified Genetic counselor, CGC, Genetic Counselor
GCMolgen@mayo.edu
1-800-533-1710
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
https://www.mayocliniclabs.com/test-catalog/Specimen/606162
Order URL
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 476
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 3
Method Category Help
Test method Help
Instrument *
Microsatellite instability testing (MSI)
Next-Generation (NGS)/Massively parallel sequencing (MPS)
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Target population: Help
Patients with solid tumors that would benefit from biomarker-assisted management
View citations (4)
  • Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer: A Joint Consensus Recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists. Li MM, et al. J Mol Diagn. 2017;19(1):4-23. doi:10.1016/j.jmoldx.2016.10.002. PMID: 27993330.
  • Marcus L, Lemery SJ, Keegan P, Pazdur R. FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors. Clin Cancer Res. 2019;25(13):3753-3758. doi:10.1158/1078-0432.CCR-18-4070. Epub 2019 Feb 20. PMID: 30787022.
  • Subbiah V, Solit DB, Chan TA, Kurzrock R. The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB) ≥10: a decision centered on empowering patients and their physicians. Ann Oncol. 2020;31(9):1115-1118. doi:10.1016/j.annonc.2020.07.002. Epub 2020 Aug 05. PMID: 32771306.
  • Instruction manual: TruSight Oncology 500 High-Throughput. Illumina; 11/2020
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
All detected variants are evaluated according to the most recent American College of Medical Genetics and Genomics (ACMG), Association for Molecular Pathology (AMP), American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) recommendations. Variants are classified based on known, predicted, or possible pathogenicity and reported with interpretive … View more

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
No. The laboratory encourages health care providers to contact the laboratory at any time to learn how the status of a particular variant may have changed over time.
Research:
Is research allowed on the sample after clinical testing is complete? Help
Research testing is only performed under IRB approved protocol with an opt-out policy in place.
Recommended fields not provided:
Clinical validity, Clinical utility, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
Next-generation sequencing is performed to estimate tumor mutational burden (TMB) and microsatellite instability (MSI) status, somatic sequence variants, gene amplifications, fusions, and specific transcript variants in solid tumors. This test detects single nucleotide variants and small insertions and deletion within 514 genes, amplification of 59 genes, gene fusions involving 55 … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The MayoComplete Solid Tumor panel utilizes the Illumina TruSight Oncology 500 chemistry to identify tumor mutation burden (TMB) status, microsatellite instability (MSI) status, sequence variants involving exonic regions and exon/intron boundaries of 514 genes ≥ 2.0% VAF, gene amplifications in 59 genes ≥ 2.2x fold change, fusions involving any of … View more
Assay limitations: Help
Next-generation sequencing is performed to estimate tumor mutational burden (TMB) and microsatellite instability (MSI) status, somatic sequence variants, gene amplifications, fusions, and specific transcript variants in solid tumors. This test detects single nucleotide variants and small insertions and deletion within 514 genes, amplification of 59 genes, gene fusions involving 55 … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP

Description of PT method: Help
CAP Vended
VUS:
Software used to interpret novel variations Help
Variants may be analyzed using any combination of the following: Qiagen Clinical Insight (QCI), Alamut, REVEL, Polyphen-2, SIFT, AGVGD, MutationTaster, SpliceSiteFinder-like, MaxEntScan, NNSPLICE, GeneSplicer, gene and somatic-specific online databases, ISCA, UCSC Genome Browser

Laboratory's policy on reporting novel variations Help
All novel alterations and copy number variants are evaluated for potential pathogenicity and included in the written report, accordingly.
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.