clonoSEQ
Use
clonoSEQ is a next-generation sequencing (NGS)–based minimal residual disease (MRD) assay used to detect and quantify residual malignant cells in patients with select hematologic malignancies, including multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL), with broader applicability across related lymphoid cancers. The test identifies patient-specific immunoglobulin or T-cell receptor gene rearrangements at baseline and tracks these unique clonotypes over time to assess depth of response, monitor for early relapse, and inform treatment decisions. With sensitivity capable of detecting one malignant cell among up to one million cells, clonoSEQ provides a highly sensitive measure of disease burden that complements conventional clinical and radiographic assessments and is increasingly incorporated into clinical guidelines and therapeutic trials.
Special Instructions
clonoSEQ requires identification of a dominant malignant clonotype from an initial baseline sample, typically obtained from bone marrow or peripheral blood, before MRD tracking can be performed; therefore, providers should ensure appropriate baseline material is submitted or previously established. Follow-up testing for MRD monitoring should be performed at clinically relevant intervals using consistent specimen types when possible to support longitudinal comparison. Specimen handling, collection timing relative to therapy, and coordination with the performing laboratory (Adaptive Biotechnologies) are important to ensure accurate detection and reproducibility, and providers should follow all laboratory-specific submission and documentation requirements.
Limitations
clonoSEQ is limited to hematologic malignancies in which a trackable immunoglobulin or T-cell receptor gene rearrangement can be identified, and the test may not be informative if a dominant clonotype cannot be established at baseline. Sensitivity may vary based on specimen quality, disease biology, and sampling site, particularly when peripheral blood is used in place of bone marrow in certain indications. As an MRD assay, clonoSEQ is not intended for initial diagnosis and should be interpreted in the context of clinical findings and other laboratory results; additionally, changes in disease clonality over time or the emergence of new clones may impact longitudinal tracking accuracy.
FDA Approved
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
7-14 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
5–10 mL
Minimum Volume
Not provided
Container
EDTA (lavender top)
Collection Instructions
Collect whole blood via standard venipuncture into an EDTA tube and gently invert to mix anticoagulant; avoid clotting.
Storage Instructions
Store at room temperature prior to shipment.
Causes for Rejection
- Clotted specimen - Insufficient volume - Improper container (non-EDTA) - Delayed shipment beyond stability window - Gross hemolysis or sample degradation
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 48–72 hours |