28 September 2018 - Today the U.S. FDA permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual disease in patients with acute lymphoblastic leukaemia or multiple myeloma.
Minmal residual disease (MRD) is a measure of the amount of cancer cells remaining in a person’s bone marrow.
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 acute lymphoblastic leukaemia or multiple myeloma. The ClonoSEQ assay measures the amount of MRD 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.