clonoSEQ Assay

Test Details

Cancer Type

Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Hematologic malignancies, Leukemia, Myeloma

Technology Used

Molecular, NGS

Turnaround Time

7-10 days

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 (ALL) or multiple myeloma (MM), and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). The clonoSEQ® Assay 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. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies Corporation in Seattle, Washington.

Special Instructions

This assay is referred out to Adaptive Biotechnologies for testing

Limitations

ALL, MM, and CLL €¢ MRD values obtained with different assay methods may not be interchangeable due to differences in assay methods and reagent specificity. €¢ The results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings. €¢ The clonoSEQ Assay is for use with specimens collected in EDTA tubes. €¢ Results may vary according to sample time within the course of disease or by sampling site location. €¢ The assay may overestimate MRD frequencies near the limit of detection (LoD). €¢ The MRD frequency LoD varies based on the amount of gDNA that is tested and using lower gDNA input may prevent MRD detection at low frequencies. €¢ Sample processing and cell enrichment strategies may affect the measured MRD frequency. €¢ The volume and cellularity of sampled input material may affect the ability to detect low levels of disease. €¢ False positive or false negative results may occur for reasons including, but not limited to: contamination; technical and/or biological factors such as the type of rearrangement or the size of the junction region. €¢ The assay has been validated with the Illumina NextSeq 500 and 550.

Methodology

Next-generation sequencing (NGS) based assay that identifies rearranged IgH (VDJ), IgH (DJ), IgK, and IgL receptor gene sequences, as well as translocated BCL1/IgH (J) and BCL2/IgH (J) sequences. The assay also includes primers that amplify specific genomic regions present as diploid copies in normal genomic DNA (gDNA) to allow determination of total nucleated cell content. The clonoSEQ Assay MRD assessment measures residual disease in a biologic sample. The complete immunoglobulin receptor repertoire is again assessed, and the previously identified dominant clonotype sequence(s) are detected and quantified to determine the sample MRD level.

Specimen Requirements

Information on collection, storage, and volume

Specimen

Whole blood; bone marrow aspirate

Volume

2mL

Container

Lavender top (EDTA)

Storage Instructions

Refrigerate

Causes for Rejection

Frozen specimen; broken or leaking container; improper anticoagulation; container not labeled or not legible.