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FDA approves minimal residual disease diagnostic

September 28, 2018 10:39 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. ...

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Adaptive Biotechnologies Corp.