www.fdanews.com/articles/188654-minimal-residual-disease-assay-for-leukemia-patients-cleared-by-fda
Minimal Residual Disease Assay for Leukemia Patients Cleared by FDA
October 3, 2018
The FDA granted 510(k) clearance to Adaptive Biotechnologies’ vitro diagnostic, which tests for minimal residual disease in patients with B-cell ALL or multiple myeloma.
The next-generation sequencing assay, ClonoSEQ, requires a minimum DNA sample of 500 nanograms.
The assay tests for minimal residual disease by identifying and counting gene sequences in DNA extracted from the patient’s bone marrow.