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CLL NextGen Sequencing Assay
Clinical Genetic Test
Help
offered by
PathGroup
View lab's test page
LinkOut
GTR Test Accession: Help GTR000603765.2
CANCERIMMUNOLOGYINHERITED DISEASE ... View more
Last updated in GTR: 2023-02-17
View version history
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Test purpose: Help
Diagnosis; Drug Response; Predictive; ...
Conditions (2): Help
Hematologic neoplasm; B-cell chronic lymphocytic leukemia
Genes (4): Help
ATM (11q22.3); NOTCH1 (9q34.3); SF3B1 (2q33.1); TP53 (17p13.1)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
PathGroup
View lab's website
View lab's test page
Test short name: Help
NGSCLL2
Specimen Source: Help
  • Bone marrow
  • Buccal swab
  • Paraffin block
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
Test Order Code: Help
NGSCLL2
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

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
See specific tests for ordering and specimen requirements
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Lab contact for this test, Test strategy, Test development
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 4
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; 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: 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
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: Help
Not provided
Additional Information
Practice guidelines:
Consumer resources:

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.