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

Jason Harris
Published: Tuesday, Oct 02, 2018

blood cellsThe 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 in 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. The assay detects as few as 1 tumor cell within more than 1 million healthy (<10-6) cells.

“At the FDA, we’re continuing to maximize opportunities for innovation that can improve patient outcomes,” FDA commissioner Scott Gottlieb, MD, said in a press release. “Today’s approval is an important step forward for patients suffering from ALL and multiple myeloma. Determining whether a patient has residual cancer cells remaining after treatment provides information on how well a patient has responded to therapy and how long remission may last. Having a highly sensitive test available to measure minimal residual disease in ALL or multiple myeloma patients can help providers manage their patients’ care.”

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