FDA Permits Use of Next-Generation Sequencing–Based Test in Multiple Myeloma
Posted: Friday, October 5, 2018
On September 28, 2018, the U.S. Food and Drug Administration (FDA) permitted marketing of ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease (MRD) in patients with multiple myeloma or acute lymphoblastic leukemia (ALL).
The ClonoSEQ assay is an in vitro diagnostic that employs multiplex polymerase chain reaction and next-generation sequencing to identify and quantify certain gene sequences in DNA extracted from bone marrow from patients with multiple myeloma or ALL. 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.
The FDA evaluated data to demonstrate its clinical validity from a retrospective analysis of samples obtained from 3 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 multiple myeloma, the ClonoSEQ assay demonstrated similar associations with progression-free and disease-free survival.
Along with this authorization, the FDA is establishing criteria (special controls) that clarify the agency’s expectations in assuring the accuracy, reliability, and effectiveness of tests intended to be used as an aid to measure MRD to assess the change in burden of disease during and after treatment. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for these tests. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
