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Hematological Malignancy Fusion Panel
Clinical Genetic Test
Help
offered by
Laboratory for Molecular Pediatric Pathology
View lab's test page
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GTR Test Accession: Help GTR000592485.3
CANCERHEMATOLOGYIMMUNOLOGY ... View more
Last updated in GTR: 2021-11-11
View version history
Last annual review date for the lab: 2024-02-12 LinkOut
At a Glance
Test purpose: Help
Diagnosis
Conditions (8): Help
Acute myeloid leukemia; Acute leukemia of ambiguous lineage; B-cell acute lymphoblastic leukemia; ...
Genes (71): Help
ABL1 (9q34.12), AFDN (6q27), ALK (2p23.2-23.1), BCL11B (14q32.2), BCL2 (18q21.33), ...
Methods (1): Help
Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
The Boston Children’s Hospital Heme Malignancy Fusion Panel assay is …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Laboratory for Molecular Pediatric Pathology
View lab's website
View lab's test page
Test short name: Help
Heme
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
Heme Malignancy Fusion Panel
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Marian Harris, PhD, MD, ABPath, Medical Director
Leslie Grimmett, MS, CG(ASCP), MB(ASCP), Administrator
leslie.grimmett@childrens.harvard.edu
United States
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
Please, contact the Laboratory for Molecular Pediatric Pathology for ordering information.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test development: Help
Manufactured (research use only; not FDA-reviewed)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test strategy
Conditions Help
Total conditions: 8
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 71
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina MiSeq
Clinical Information
Test purpose: Help
Diagnosis
Target population: Help
The Boston Children’s Hospital Heme Malignancy Fusion Panel assay is based on the ArcherDX FusionPlex® Heme v2 panel. The assay targets genes with known diagnostic, prognostic and/or therapeutic significance in hematologic malignancies, and is validated to detect fusions of 72 target genes, either between the targeted genes, or between a … View more
Recommended fields not provided:
Clinical validity, Clinical utility, 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:
Archer DX FusionPlex® Heme v2
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The overall sensitivity of the assay is 96.6%, and the specificity is 100%. These results are within the accepted success rates of >95% sensitivity and specificity as described in the validation plan. The positive predictive value of the assay is 100% and the negative predictive value is 93.75%.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Intra-Laboratory

Description of PT method: Help
Blind sample proficiency testing of samples
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
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.