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Targeted Oncology Microarray Analysis
Clinical Genetic Test
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offered by
Institute for Genomic Medicine (IGM) Clinical Laboratory
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GTR Test Accession: Help GTR000597228.1
CANCERINHERITED DISEASEURINARY SYSTEM DISEASE ... View more
Last updated in GTR: 2021-12-14
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Last annual review date for the lab: 2023-07-14 LinkOut
At a Glance
Test purpose: Help
Prognostic; Risk Assessment; Therapeutic management
Conditions (7): Help
Wilms tumor 5; Nephroblastoma; Neuroblastoma; ...
Chromosomal regions/ Mitochondria (7): Help
Gain of 1q; Gain of 1q, 2p, 17q; LOH at 1p, 11p15, and 17p; LOH at 1p, 3p, 4p and 11q; Loss of 1p, 11p15, 16q, and 17p; ...
Methods (1): Help
Molecular Genetics - Deletion/duplication analysis: Microarray
Target population: Help
Individuals diagnosed with Wilms tumor or Neuroblastoma.
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Institute for Genomic Medicine (IGM) Clinical Laboratory
View lab's website
View lab's test page
Manufacturer's name: Help
Affymetrix OncoScan CNV Assay
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
Test Order Code: Help
TONCMA
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

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
Samples can be accepted 7 days a week (Monday - Sunday). All samples must be labeled with minimum of two patient identifying information (e.g., Patient Name and Date of Birth). Please Submit disease-involved sample with a completed requisition form and a pathology report documenting the diagnosis. Please refer to our …
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Order URL
Test development: Help
Manufactured (research use only; not FDA-reviewed)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Lab contact for this test, Test strategy
Conditions Help
Total conditions: 7
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 7
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Deletion/duplication analysis
Microarray
* Instrument: Not provided
Clinical Information
Test purpose: Help
Prognostic; Risk Assessment; Therapeutic management
Target population: Help
Individuals diagnosed with Wilms tumor or Neuroblastoma.
Variant Interpretation:
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
Not provided. No systemic re-evaluation of previously reported variants/findings are currently performed.
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Platform:
Affymetrix CytoScan HD Array
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
For regions targeted by this assay, >95% sensitivity for detecting loss/gain/LOH of the region. The sensitivity, specificity, and accuracy/precision of this assay is dependent upon the quality of the input DNA. Highly degraded DNA and contaminated DNA will yield poor results.
Assay limitations: Help
Following will not be detected: genomic loss, gain, or LOH outside of the targeted regions, balanced chromosomal rearrangements
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Intra-Laboratory
VUS:
Laboratory's policy on reporting novel variations Help
Unusual or clinically significant novel variants will be communicated to the ordering provider via telephone call or email communication.
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
Additional Information

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.