NGS Assay for MRD Detection Gains FDA Approval for 2 Blood Cancers

October 2, 2018 – The FDA has approved the next-generation sequencing (NGS) assay clonoSEQ as a test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. The vitro diagnostic, which is manufactured by Adaptive Biotechnologies, identifies and quantifies gene sequences in DNA extracted from the bone marrow of patients with ALL or multiple myeloma using multiplex polymerase chain reaction and NGS … (leggi tutto)