Genetic Test Evaluation

understanding how genetic tests impact patient management

clonoSEQ (Adaptive Biotechnologies)

November 15, 2018

This report evaluates the analytical validity, clinical validity, and clinical utility of Food and Drug Administration (FDA)-cleared clonoSEQ (Adaptive Biotechnologies) to detect and measure minimal residual disease (MRD) in bone marrow samples from patients with multiple myeloma or B-cell acute lymphoblastic leukemia in order to monitor changes in burden of disease during and after treatment. Also evaluated are non-FDA-cleared indications for MRD monitoring, including non-Hodgkin’s lymphoma, T-cell lymphoma, Sézary syndrome, and other malignancies.