Acquired genetic alteration IVDs

Intended purpose

The clonoSEQ Assay B-Cell Reagent Set is a quantitative in vitro diagnostic (IVD) assay that uses multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged B-cell receptor gene sequences, including IgH (VDJ), IgH (DJ), IgK, and IgL and translocated BCL1/IgH (J) and BCL2/IgH (J) sequences in DNA extracted from blood and bone marrow. The clonoSEQ Assay is a manual test that determines measurable/minimal residual disease (MRD) and monitors changes in disease burden during and after treatment in B-cell malignancies. The test is indicated for use by qualified healthcare professionals as an aid to clinical decision-making in conjunction with other clinicopathological features.