GTR Test Accession:
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GTR000603763.1
CAP
Last updated in GTR: 2022-12-21
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GTR000603763.1, last updated: 2022-12-21
Last annual review date for the lab: 2022-12-28
Past due
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At a Glance
Test purpose:
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Predictive;
Prognostic;
Drug Response; ...
Conditions (16):
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Thrombocythemia 1; Acute lymphoid leukemia; Acute myeloid leukemia; ...
Genes (160):
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ABL1 (9q34.12), AKT1 (14q32.33), AKT2 (19q13.2), AKT3 (1q43-44), ALK (2p23.2-23.1), ...
Methods (1):
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Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Myeloproliferative neoplasms, Acute myeloid leukemia, Hematological neoplasms and associated syndromes
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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CALR, FLT3, HEMECP, FUSIONHM
Specimen Source:
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- Peripheral (whole) blood
- Bone marrow
- Paraffin block
- View specimen requirements
Who can order: Help
- Health Care Provider
CPT codes:
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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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SMGNGSEHM+CALR+FLT3+FusionHM
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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No
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Test Order Code,
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 16
| Condition/Phenotype | Identifier |
|---|
Test Targets
Genes
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Total genes: 160
| Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Predictive;
Prognostic;
Drug Response;
Diagnosis
Target population:
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Myeloproliferative neoplasms, Acute myeloid leukemia, Hematological neoplasms and associated syndromes
Recommended fields not provided:
Clinical validity,
Clinical utility,
What is the protocol for interpreting a variation as a VUS?,
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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Analytic sensitivity >99% when variant is present at >5% VAF (FFPE requires minimum of 20% tumor cells). Analytic specificity of >99%. Precision and reproducibility of >98%.
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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Category:
FDA exercises enforcement discretion
Additional Information
Reviews:
Clinical resources:
Consumer resources:
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with specific questions about a genetic test should contact a health care provider or a genetics professional.