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Onco microarray for MDS/AML
Clinical Genetic Test
Help
offered by
Pittsburgh Cytogenetics Laboratory
View lab's test page
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GTR Test Accession: Help GTR000527619.2
CANCERHEMATOLOGYINHERITED DISEASE ... View more
Last updated in GTR: 2016-12-23
View version history
Last annual review date for the lab: 2024-05-22 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Prognostic; Recurrence; ...
Conditions (2): Help
Myelodysplastic syndrome; Acute myeloid leukemia
Chromosomal regions/ Mitochondria (9): Help
5q33-34; 9q-; Chromosomal gains, losses; trisomy 11; trisomy 13 more...
Genes (60): Help
ABL1 (9q34.12); ACSL6 (5q31.1); AFDN (6q27); AFF1 (4q21.3-22.1); ALK (2p23.2-23.1) more...
Methods (2): Help
Molecular Genetics - Deletion/duplication analysis: Microarray; ...
Target population: Help
children and adults with MDS, MDS transformed to AML, AML
Clinical validity: Help
Not provided
Clinical utility: Help
Establish or confirm diagnosis; Guidance for management
Ordering Information
Offered by: Help
Pittsburgh Cytogenetics Laboratory
View lab's website
View lab's test page
Specimen Source: Help
  • Bone marrow
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
Test Order Code: Help
Kancerray
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
For more information, please contact the laboratory directly.
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Test strategy: Help
Copy number analysis by aCGH to identyfy alterations in genes involved in myeloid differentiation, proliferation, cell cycle and to provide important diagnostic and prognostic information that is routinely used in risk stratification for treatment.
View citations (1)
  • NCCN Clinical Practice Guidelines Acute myeloid leukemia. O'Donnell MR, et al. J Natl Compr Canc Netw. 2012;10(8):984-1021. doi:10.6004/jnccn.2012.0103. PMID: 22878824.
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Lab contact for this test
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 9
Chromosomal region/Mitochondrion Associated condition
Genes Help
Total genes: 60
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument
Deletion/duplication analysis
Microarray
Agilent SureSelect
Detection of homozygosity
Microarray
Agilent SureSelect
Clinical Information
Test purpose: Help
Diagnosis; Prognostic; Recurrence; Risk Assessment; Therapeutic management
Clinical utility: Help
Establish or confirm diagnosis
View citations (1)
  • Fey MF, Buske C, . Acute myeloblastic leukaemias in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24 Suppl 6:vi138-43. doi:10.1093/annonc/mdt320. Epub 2013 Aug 22. PMID: 23970018.

Guidance for management
View citations (2)
  • Fey MF, Buske C, . Acute myeloblastic leukaemias in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24 Suppl 6:vi138-43. doi:10.1093/annonc/mdt320. Epub 2013 Aug 22. PMID: 23970018.
  • Kihara R, Nagata Y, Kiyoi H, Kato T, Yamamoto E, Suzuki K, Chen F, Asou N, Ohtake S, Miyawaki S, Miyazaki Y, Sakura T, Ozawa Y, Usui N, Kanamori H, Kiguchi T, Imai K, Uike N, Kimura F, Kitamura K, Nakaseko C, Onizuka M, Takeshita A, Ishida F, Suzushima H, Kato Y, Miwa H, Shiraishi Y, Chiba K, Tanaka H, Miyano S, Ogawa S, Naoe T. Comprehensive analysis of genetic alterations and their prognostic impacts in adult acute myeloid leukemia patients. Leukemia. 2014;28(8):1586-95. doi:10.1038/leu.2014.55. Epub 2014 Feb 03. PMID: 24487413.

Target population: Help
children and adults with MDS, MDS transformed to AML, AML
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: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
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 … View more
Assay limitations: Help
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 … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
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: Help
Category: Not Applicable
Additional Information

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