FDA approves ClonoSEQ assay for ALL and multiple myeloma.- Adaptive Biotechnologies.

The FDA has permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test, from Adaptive Biotechnologies, for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. The FDA reviewed the ClonoSEQ assay through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type.

The ClonoSEQ assay is an in vitro diagnostic that uses multiplex PCR and NGS to identify and quantify certain gene sequences in DNA extracted from bone marrow from patients with ALL or multiple myeloma. The ClonoSEQ assay measures the amount of MRD - a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person's bone marrow - and is capable of detecting MRD at levels below 1 in 1 million cells. This is a single site assay collected by the patient's provider and sent to Adaptive Biotechnologies Corporation for evaluation.

The FDA evaluated data to demonstrate clinical validity from a retrospective analysis of samples obtained from three previously conducted clinical studies including 273 patients with ALL, an ongoing study of 323 patients with multiple myeloma, and a study of 706 patients with multiple myeloma. For patients with ALL, the ClonoSEQ assay was used to assess MRD at various disease burden thresholds to show that the MRD level correlated with event-free survival�the length of time, after treatment, that the patient remains free of certain complications or events. Patients whose ClonoSEQ assay result was MRD negative have longer event-free survival, while patients with higher MRD assay results had lower event-free survival rates. For patients with multiple myeloma, the ClonoSEQ assay demonstrated similar associations with progression-free survival�the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse�and disease-free survival�the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.