Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000607931.2
Last updated in GTR:
2023-06-27
View version history
GTR000607931.2,
last updated:
2023-06-27
GTR000607931.1,
registered in GTR:
2023-06-23
Last annual review date for the lab: 2024-06-14
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At a Glance
Test purpose:
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Diagnosis;
Drug Response;
Prognostic; ...
Conditions (9):
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chromosomal region/mitochondrion: classification prediction score indicating the resemblance to a CNS tumor subtype based on methylation profile.;
classification prediction score indicating the resemblance to a CNS tumor subtype based on methylation profile.
Methods (1):
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Molecular Genetics - Methylation analysis: Microarray
Target population: Help
Patients diagnosed with a CNS tumor.
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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CNS Methyl Array
Manufacturer's name:
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Illumina MethylationEPIC BeadChip
Specimen Source:
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- Fresh tissue
- Frozen tissue
- Paraffin block
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
Test Order Code:
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CTCMA
View other test codes
View other test codes
Contact Policy:
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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:
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Samples can be accepted 7 days a week (Monday - Sunday). All samples must be labeled with the name and at least one secondary identifier (e.g. MRN, DOB, SPID). Please Submit disease involved sample with a completed requisition form and a pathology report documenting the diagnosis. Please refer to our …
Order URL
Informed consent required:
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No
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Lab contact for this test,
Test strategy,
Test development
Conditions
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Total conditions: 9
Condition/Phenotype | Identifier |
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Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 2
Chromosomal region/Mitochondrion | Associated condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Methylation analysis
Microarray
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Drug Response;
Prognostic;
Therapeutic management
Target population:
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Patients diagnosed with a CNS tumor.
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided.
Not provided.
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 Comments:
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This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip platform and software developed by the German Cancer Research Center (DKFZ) to subtype CNS tumors (see references below). This array assesses a whole genome methylation profile (over 850,000 CpG sites) and compares it …
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Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors to subtype CNS tumors. This array assesses a whole genome methylation profile (over 850,000 CpG sites) and compares it to over 2,800 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor …
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Assay limitations:
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This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Alternative Assessment
Yes
Method used for proficiency testing: Help
Alternative Assessment
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:
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Not provided
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
IMPORTANT NOTE:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.