Comprehensive Myeloid Profile + CALR PCR + FLT3 PCR
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000593426.2
CAP
HEMATOLOGYCANCERINHERITED DISEASE ... View more
Last updated 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; ...
Hematologic disorder; Acute lymphoid leukemia; Acute myeloid leukemia more...
ABL1 (9q34.12); ASXL1 (20q11.21); ATM (11q22.3); ATRX (Xq21.1); BCORL1 (Xq26.1) 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
MYELOIDCPCALRFLT3
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
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
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: 65
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
College of American Pathologists, CAP
Recommended fields not provided:
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.