GTR Test Accession:
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GTR000527618.1
Registered in GTR:
2015-08-12
View version history
GTR000527618.1,
registered in GTR:
2015-08-12
Last annual review date for the lab: 2024-05-22
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At a Glance
Test purpose:
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Diagnosis;
Prognostic;
Recurrence; ...
Conditions (1):
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Precursor B-cell acute lymphoblastic leukemia
P2RY8-CRLF2 (PAR1);
amplification chromosome 21 (iAMP21);
double hypodiploidy;
hyperdiploidy;
hypodiploidy
more...
Genes (10):
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Methods (2):
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Molecular Genetics - Deletion/duplication analysis: Microarray; ...
Target population: Help
children and adults with B-cell precursor acute lymphoblastic leukemia
Clinical validity:
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Not provided
Clinical utility:
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Establish or confirm diagnosis;
Guidance for management
Ordering Information
Offered by:
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Test short name:
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Kancerray
Specimen Source:
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- Bone marrow
- Peripheral (whole) blood
Who can order: Help
- Health Care Provider
Test Order Code:
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Kancerray
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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For more information, please contact the laboratory directly.
Test development:
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Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required:
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Decline to answer
Test strategy:
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Copy number analysis by aCGH to identyfy alterations in genes involved in lymphoid differentiation, proliferation, cell cycle and to provide important diagnostic and prognostic information that is routinely used in risk stratification for treatment.
View citations (3)
- Moorman AV, Enshaei A, Schwab C, Wade R, Chilton L, Elliott A, Richardson S, Hancock J, Kinsey SE, Mitchell CD, Goulden N, Vora A, Harrison CJ. A novel integrated cytogenetic and genomic classification refines risk stratification in pediatric acute lymphoblastic leukemia. Blood. 2014;124(9):1434-44. doi:10.1182/blood-2014-03-562918. Epub 2014 Jun 23. PMID: 24957142.
- Integration of microarray analysis into the clinical diagnosis of hematological malignancies: How much can we improve cytogenetic testing?. Peterson JF, et al. Oncotarget. 2015;6(22):18845-62. doi:10.18632/oncotarget.4586. PMID: 26299921.
- Boer JM et al. Leukemia (2015), 1–7
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:
Lab contact for this test
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 8
Chromosomal region/Mitochondrion | Associated condition |
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Genes
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Total genes: 10
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 2
Method Category
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Test method
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Instrument
Deletion/duplication analysis
Microarray
Agilent SureSelect
Detection of homozygosity
Microarray
Agilent SureSelect
Clinical Information
Test purpose:
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Diagnosis;
Prognostic;
Recurrence;
Risk Assessment
Clinical utility:
Help
Establish or confirm diagnosis
Guidance for management
View citations (1)
- Moorman AV, Enshaei A, Schwab C, Wade R, Chilton L, Elliott A, Richardson S, Hancock J, Kinsey SE, Mitchell CD, Goulden N, Vora A, Harrison CJ. A novel integrated cytogenetic and genomic classification refines risk stratification in pediatric acute lymphoblastic leukemia. Blood. 2014;124(9):1434-44. doi:10.1182/blood-2014-03-562918. Epub 2014 Jun 23. PMID: 24957142.
Guidance for management
View citations (2)
- Moorman AV, Enshaei A, Schwab C, Wade R, Chilton L, Elliott A, Richardson S, Hancock J, Kinsey SE, Mitchell CD, Goulden N, Vora A, Harrison CJ. A novel integrated cytogenetic and genomic classification refines risk stratification in pediatric acute lymphoblastic leukemia. Blood. 2014;124(9):1434-44. doi:10.1182/blood-2014-03-562918. Epub 2014 Jun 23. PMID: 24957142.
- Boer JM, van der Veer A, Rizopoulos D, Fiocco M, Sonneveld E, de Groot-Kruseman HA, Kuiper RP, Hoogerbrugge P, Horstmann M, Zaliova M, Palmi C, Trka J, Fronkova E, Emerenciano M, do Socorro Pombo-de-Oliveira M, Mlynarski W, Szczepanski T, Nebral K, Attarbaschi A, Venn N, Sutton R, Schwab CJ, Enshaei A, Vora A, Stanulla M, Schrappe M, Cazzaniga G, Conter V, Zimmermann M, Moorman AV, Pieters R, den Boer ML. Prognostic value of rare IKZF1 deletion in childhood B-cell precursor acute lymphoblastic leukemia: an international collaborative study. Leukemia. 2016;30(1):32-8. doi:10.1038/leu.2015.199. Epub 2015 Jul 23. PMID: 26202931.
Target population:
Help
children and adults with B-cell precursor acute lymphoblastic leukemia
View citations (2)
- Moorman AV, Enshaei A, Schwab C, Wade R, Chilton L, Elliott A, Richardson S, Hancock J, Kinsey SE, Mitchell CD, Goulden N, Vora A, Harrison CJ. A novel integrated cytogenetic and genomic classification refines risk stratification in pediatric acute lymphoblastic leukemia. Blood. 2014;124(9):1434-44. doi:10.1182/blood-2014-03-562918. Epub 2014 Jun 23. PMID: 24957142.
- Boer JM, van der Veer A, Rizopoulos D, Fiocco M, Sonneveld E, de Groot-Kruseman HA, Kuiper RP, Hoogerbrugge P, Horstmann M, Zaliova M, Palmi C, Trka J, Fronkova E, Emerenciano M, do Socorro Pombo-de-Oliveira M, Mlynarski W, Szczepanski T, Nebral K, Attarbaschi A, Venn N, Sutton R, Schwab CJ, Enshaei A, Vora A, Stanulla M, Schrappe M, Cazzaniga G, Conter V, Zimmermann M, Moorman AV, Pieters R, den Boer ML. Prognostic value of rare IKZF1 deletion in childhood B-cell precursor acute lymphoblastic leukemia: an international collaborative study. Leukemia. 2016;30(1):32-8. doi:10.1038/leu.2015.199. Epub 2015 Jul 23. PMID: 26202931.
Recommended fields not provided:
Clinical validity,
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
Test Platform:
Agilent SurePrint G3 Human CGH Microarray Kit, 2x400K
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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This test is evaluated for analytical validity using an established validation process utilizing abnormal and normal specimens as per CAP, ACMG, and CLIA guidelines. Microarray platform includes oligonucleotide probes for the 898 genes known to be involved in carcinogenesis, subtelomeric, pericentromeric regions, as well as breakpoint “hot spot” intervals associated …
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Assay limitations:
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Although microarray detects microscopic and submicroscopic deletions and duplications undetectable by karyotyping, microarray will not detect balanced chromosome rearrangements, such as balanced translocations or inversions. It will not detect alterations in chromosome structure at areas of the genome not covered by the array. This technology will not detect sequence alterations …
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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
Intra-Laboratory
Description of internal test validation method: Help
Karyotyping, FISH analysis
Yes
Method used for proficiency testing: Help
Intra-Laboratory
Description of internal test validation method: Help
Karyotyping, FISH analysis
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
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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Category:
Not Applicable
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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