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INTENDED USE:
The clonoSEQ Assay is an in vitro diagnostic that uses multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged IgH (VDJ), IgH (DJ), IgK, and IgL receptor gene sequences, as well as translocated BCL1/IgH (J) and BCL2/IgH (J) sequences in DNA extracted from bone marrow from patients with B-cell acute lymphoblastic leukemia or multiple myeloma.
clonoSEQ measures minimal residual disease (MRD) to monitor changes in burden of disease during and after treatment. The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features.
clonoSEQ is a single-site assay performed at Adaptive Biotechnologies.
Special Conditions for Use:
- For in vitro diagnostic use.
- For prescription use only (Rx only).
Limitations:
- clonoSEQ is for use with bone marrow specimens collected in EDTA tubes.
- Results should always be used in combination with clinical examination, patient medical history, and other findings.
- Results may vary according to sample time within the course of disease or by sampling site location.
- clonoSEQ may overestimate MRD frequencies near the limit of detection (LoD).
- MRD frequency LoD varies based on the amount of DNA tested; using less DNA input may prevent MRD detection at low frequencies.
- The volume and cellularity of sampled input material may affect the ability to detect low levels of disease.
- Sample processing and cell enrichment strategies may affect the measured MRD frequency.
- False positive or false negative results may occur for reasons including, but not limited to: contamination, technical, and/or biological factors.
- MRD values obtained with different assay methods may not be interchangeable due to differences in assay methods and reagent specificity.
- clonoSEQ is a single-site assay performed at Adaptive Biotechnologies.