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clonoSEQ®
Clinical Genetic Test
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offered by
Adaptive Biotechnologies
View lab's test page
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GTR Test Accession: Help GTR000604129.1
NYS CLEP
HEMATOLOGYCANCERINHERITED DISEASE ... View more
Last updated in GTR: 2023-03-13
View version history
Last annual review date for the lab: Past due LinkOut
At a Glance
Test purpose: Help
Drug Response; Monitoring; Prognostic; ...
Conditions (5): Help
Acute lymphoid leukemia; B-cell chronic lymphocytic leukemia; Childhood acute lymphoblastic leukemia more...
Genes (3): Help
IGH (14q32.33); IGK (2p11.2); IGL (22q11.22)
Methods (1): Help
Molecular Genetics - Sequence analysis of select exons: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Oncology (hematolymphoid neoplasm)
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Adaptive Biotechnologies
View lab's test page
Manufacturer's name: Help
clonoSEQ®
Specimen Source: Help
  • Bone marrow
  • Cell-free DNA
  • Fresh tissue
  • Frozen tissue
  • Blood
  • Paraffin block
  • Plasma
Who can order: Help
  • Health Care Provider
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
Order URL
Test service: Help
clonoSEQ MRD
Test development: Help
FDA-reviewed (has FDA test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Lab contact for this test, Test strategy
Conditions Help
Total conditions: 5
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 3
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response; Monitoring; Prognostic; Therapeutic management
Target population: Help
Oncology (hematolymphoid neoplasm)
Recommended fields not provided:
Clinical validity, Clinical utility, 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
LoD and LoQ were estimated at 1.903 cells and 2.390 malignant cells, respectively. LoB was zero in healthy donor gDNA. Precision ranged from 18% CV (coefficient of variation) at higher DNA inputs to 68% CV near the LoD. Variance component analysis showed MRD results were robust, with expected laboratory process … View more
View citations (1)
  • Ching T, Duncan ME, Newman-Eerkes T, McWhorter MME, Tracy JM, Steen MS, Brown RP, Venkatasubbarao S, Akers NK, Vignali M, Moorhead ME, Watson D, Emerson RO, Mann TP, Cimler BM, Swatkowski PL, Kirsch IR, Sang C, Robins HS, Howie B, Sherwood A. Analytical evaluation of the clonoSEQ Assay for establishing measurable (minimal) residual disease in acute lymphoblastic leukemia, chronic lymphocytic leukemia, and multiple myeloma. BMC Cancer. 2020;20(1):612. doi:10.1186/s12885-020-07077-9. Epub 2020 Jun 30. PMID: 32605647.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Assay(s)
FDA Regulatory Status: FDA cleared/approved
NYS CLEP Approval: Help
Number: 63119
Status: Approved
Additional Information

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