GTR Test Accession:
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GTR000597284.1
CAP
Registered in GTR:
2021-12-28
View version history
GTR000597284.1,
registered in GTR:
2021-12-28
Last annual review date for the lab: 2024-06-07
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At a Glance
Test purpose:
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Mutation Confirmation
Conditions (3):
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Acute myeloid leukemia;
Myelodysplastic syndrome;
Myeloproliferative neoplasm
Genes (72):
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Methods (1):
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Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Manufacturer's name:
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Oncomine Myeloid Assay
Specimen Source:
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- Bone marrow
- Peripheral (whole) blood
Who can order: Help
- Health Care Provider
CPT codes:
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Lab contact:
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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.
Test development:
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Manufactured (research use only; not FDA-reviewed)
Informed consent required:
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Decline to answer
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
Test Order Code,
How to Order,
Test strategy
Conditions
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Total conditions: 3
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 72
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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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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Mutation Confirmation
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
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
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Accuracy Correlation studies were performed comparing results of extracted DNA-only samples, RNA-only samples, peripheral blood samples, and bone marrow samples. Comprehensive positive controls were also used. Component SNP, MNP INDEL FLT3 ITD Fusion PPA (Sensitivity) 98.2% >99% >99% >99% Limit of Detection LOD was determined for each variant type (SNV/MNV, …
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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
College of American Pathologists, CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, 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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Not provided
Additional Information
Clinical resources:
Molecular resources:
Practice guidelines:
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with specific questions about a genetic test should contact a health care provider or a genetics professional.