The FDA has authorized use of the clonoSEQ Assay (Adaptive Biotechnologies) to monitor and detect minimal residual disease (MRD) in patients with B-cell acute lymphoblastic leukemia (ALL) and multiple myeloma (MM). The clonoSEQ Assay, which uses next-generation sequencing technology to identify and analyze MRD in patients with ALL and MM, is the first assay to be approved by the FDA for assessment of MRD in lymphoid cancer and the first FDA-approved diagnostic assay powered by immunosequencing.
OCTOBER 22, 2018