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05-10-2018 | FDA | News

approvalsWatch

NGS test approved for ALL, multiple myeloma residual disease

medwireNews: The US FDA has authorized marketing of a next-generation sequencing (NGS) test for the detection of minimal residual disease (MRD) in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma.

The ClonoSEQ assay (Adaptive Biotechnologies Corp, Seattle, Washington, USA) uses multiplex polymerase chain reaction and NGS to detect MRD to below 1 in 1 million cells. This compares with detection of 1 in 10,000 or 1 in 100,000 cells with earlier technologies such as flow cytometry or prior polymerase chain reaction assays.

The approval follows data demonstrating a longer duration of event-free survival for ALL patients with a ClonoSEQ assay result indicating no MRD versus a positive result. Similarly, progression-free and disease-free survival durations were better for multiple myeloma patients with a negative MRD assay than those with a positive finding.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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