Comprehensive HemeComplete Profile + Heme Fusion + CALR PCR + … see more Comprehensive HemeComplete Profile + Heme Fusion + CALR PCR + FLT3 PCR  see less
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000603763.1
CAP
HEMATOLOGYCANCERINHERITED DISEASE ... View more
Registered in GTR: 2022-12-21
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Diagnosis; Drug Response; Predictive; ...
Thrombocythemia 1; Acute lymphoid leukemia; Acute myeloid leukemia more...
ABL1 (9q34.12); AKT1 (14q32.33); AKT2 (19q13.2); AKT3 (1q43-44); ALK (2p23.2-23.1) more...
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Myeloproliferative neoplasms, Acute myeloid leukemia, Hematological neoplasms and associated syndromes
Not provided
Not provided
Ordering Information
Test short name: Help
CALR, FLT3, HEMECP, FUSIONHM
Specimen Source: Help
  • Bone marrow
  • Paraffin block
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
CPT codes: Help
**AMA CPT codes notice
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
SMGNGSEHM+CALR+FLT3+FusionHM
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 16
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 160
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Drug Response; Predictive; Prognostic
Target population: Help
Myeloproliferative neoplasms, Acute myeloid leukemia, Hematological neoplasms and associated syndromes
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
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? Help
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:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information

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