ARTICLE | Clinical News
FDA approves minimal residual disease diagnostic
October 5, 2018 7:29 PM UTC
FDA approved clonoSEQ Assay from Adaptive Biotechnologies Corp. (Seattle, Wash.) to detect minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM).
The agency said clonoSEQ Assay is the first approved next-generation sequencing-based test for MRD in the patient population. The approval came via FDA’s de novo premarket review pathway. ...
BCIQ Company Profiles