Hematologic Cancer Fusion Analysis - Clinical Genetic Test - GTR

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Hematologic Cancer Fusion Analysis

Clinical Genetic Test

offered by

Institute for Genomic Medicine (IGM) Clinical Laboratory

View lab's test page

GTR Test Accession: GTR000597220.2

CAP

CANCER

Last updated in GTR: 2023-01-04

Last annual review date for the lab: 2024-06-14

At a Glance

Test purpose:

Therapeutic management

Conditions (1):

Hematologic neoplasm

Genes (147):

ABL1 (9q34.12); ABL2 (1q25.2); AFDN (6q27); AICDA (12p13.31); ALK (2p23.2-23.1) more...

Methods (1):

Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)

Target population:

Patients who have been diagnosed to have hematologic malignancy

Clinical validity:

Not provided

Clinical utility:

Not provided

Ordering Information

Offered by:

Institute for Genomic Medicine (IGM) Clinical Laboratory
View lab's website
View lab's test page

Test short name:

Heme Archer

Manufacturer's name:

FusionPlex Pan-Heme Panel

Specimen Source:

Bone marrow
Fresh tissue
Frozen tissue
Paraffin block
Peripheral (whole) blood
View specimen requirements

Who can order:

Genetic Counselor
Health Care Provider
Licensed Physician
Nurse Practitioner

Test Order Code:

HEMFUSN
View other test codes

Lab contact:

Kathleen Schieffer, Lab Director
Kathleen.Schieffer@nationwidechildrens.org
+1 (614) 355-2894

Contact Policy:

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:

Samples can be accepted 7 days a week (Monday - Sunday). All samples must be labeled with minimum of two patient identifying information (e.g. Patient Name and Date of Birth). Please Submit disease involved sample with a completed requisition form and a pathology report documenting the diagnosis. Please refer to …

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Order URL

Test development:

Manufactured (research use only; not FDA-reviewed)

Informed consent required:

Pre-test genetic counseling required:

Post-test genetic counseling required:

Recommended fields not provided:

Test strategy

Conditions

Total conditions: 1

Condition/Phenotype	Identifier

Test Targets

Genes

Total genes: 147

Gene	Associated Condition	Germline or Somatic	Allele (Lab-provided)	Variant in NCBI

Methodology

Total methods: 1

Method Category

Test method

Instrument *

RNA analysis

Next-Generation (NGS)/Massively parallel sequencing (MPS)

* Instrument: Not provided

Clinical Information

Test purpose:

Therapeutic management

Target population:

Patients who have been diagnosed to have hematologic malignancy

Variant Interpretation:

What is the protocol for interpreting a variation as a VUS?
VUS and novel variants will be interpreted by trained variant analysis team member and a lab director using the current ACMG variant classification criteria.

Are family members with defined clinical status recruited to assess significance of VUS without charge?
No.

Will the lab re-contact the ordering physician if variant interpretation changes?
Yes. No systemic re-evaluation of previously reported variants/findings are currently performed. However, if the same variant/finding is identified in another patient and current assessment results in change in variant classification/interpretation, then the laboratory will recontact the ordering provider and issue an updated report.

Recommended fields not provided:

Clinical validity, Clinical utility, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report

Technical Information

Test Comments:

CPT code updated 2023 to 81456

Availability:

Tests performed
Entire test performed in-house

Analytical Validity:

This assay detects gene fusions involving listed genes as a fusion gene partner. >99% of gene fusions involving these gene partners are detected by this assay if sample contains minimum blast/tumor % content requirement for this test (10% for fresh/frozen sample; 25% for FFPE sample).

Proficiency testing (PT):

Is proficiency testing performed for this test?
Yes

Method used for proficiency testing:
Formal PT program

PT Provider:
College of American Pathologists, CAP

VUS:

Laboratory's policy on reporting novel variations
Unusual or clinically significant novel variants will be communicated to the ordering provider via telephone call or email communication.

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:

Category: Not Applicable

Additional Information

Reviews:

PubMed Clinical Queries

Clinical resources:

Molecular resources:

View H3C2 variations in ClinVar

Practice guidelines:

Nguyen et al., 2011

Consumer resources:

MedlinePlus

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.