GTR Test Accession:
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GTR000552197.3
CAP
Last updated in GTR:
2018-07-02
View version history
GTR000552197.3,
last updated:
2018-07-02
GTR000552197.2,
last updated:
2018-01-12
GTR000552197.1,
registered in GTR:
2016-10-25
Last annual review date for the lab: 2019-10-16
Past due
LinkOut
At a Glance
Test purpose:
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Diagnosis;
Prognostic;
Therapeutic management
Conditions (11):
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Mutations of 73 genes: ASXL1, ATM, BCOR, BIRC3, BRAF, BTK, CALR, CARD11, CBL, CBLB, CCND1, CCND3, CD79A, CD79B, CDKN2A, CEBPA, CREBBP, CSF3R, DNMT3A, EP300, ETV6, EZH2, FLT3, FBXW7, GATA1, GATA2, HRAS, ID3, IDH1, IDH2, IKZF1, IL7R, JAK1, JAK2, JAK3, KDM6A;
Targeted gene rearrangements of 74 genes: ABL1, ABL2, ALK, BCL11B, BCL2, BCL6, BCR, BIRC3, CBFB, CCND1, TFG, CCND3, CDK6, CHD1, CHIC2, CIITA, CREBBP, CRLF2, CSF1R, DEK, DUSP22, TP63, EBF1, EIF4A1, EPOR, ERG, ETV6, FGFR1, GLIS2, IKZF1, IKZF2, IKZF3, TYK2,
Methods (2):
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Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Specimen Source:
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- Bone marrow
Who can order: Help
- Genetic Counselor
- Health Care Provider
Test Order Code:
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HopeSeq HemeComplete
Lab contact:
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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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Informed consent required:
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Decline to answer
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
Test strategy,
Test development
Conditions
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Total conditions: 11
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: 2
Method Category
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Test method
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Instrument *
Deletion/duplication 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:
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Diagnosis;
Prognostic;
Therapeutic management
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
What is the protocol for interpreting a variation as a VUS?,
Are family members with defined clinical status recruited to assess significance of VUS without charge?,
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
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Technical accuracy greater than 90%
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
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:
Molecular resources:
Practice guidelines:
Consumer resources:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.