GTR Test Accession:
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GTR000603765.2
Last updated in GTR:
2023-02-17
View version history
GTR000603765.2,
last updated:
2023-02-17
GTR000603765.1,
registered in GTR:
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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Diagnosis;
Drug Response;
Predictive; ...
Conditions (2):
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Hematologic neoplasm;
B-cell chronic lymphocytic leukemia
Genes (4):
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ATM (11q22.3);
NOTCH1 (9q34.3);
SF3B1 (2q33.1);
TP53 (17p13.1)
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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Test short name:
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NGSCLL2
Specimen Source:
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- Bone marrow
- Buccal swab
- Paraffin block
- Peripheral (whole) blood
Who can order: Help
- Health Care Provider
Test Order Code:
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NGSCLL2
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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See specific tests for ordering and specimen requirements
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:
Lab contact for this test,
Test strategy,
Test development
Conditions
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Total conditions: 2
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 4
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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Diagnosis;
Drug Response;
Predictive;
Prognostic;
Recurrence
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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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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No
No
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
PT Provider,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Not provided
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
Consumer resources:
IMPORTANT NOTE:
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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.