FDA authorizes ClonoSEQ assay, a next generation sequencing (NGS) test for minimal residual disease
Updated: Oct 18, 2021
ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD)
FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma
Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow....
he 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. Along with this authorization, the FDA is establishing criteria, called special controls, which 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.
The FDA granted marketing authorization of ClonoSEQ assay to Adaptive Biotechnologies.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.