FDA Clearance Granted for Assay for Monitoring Minimal Residual Disease in CLL
Posted: Tuesday, August 11, 2020
On August 7, the U.S. Food and Drug Administration (FDA) granted clearance for clonoSEQ, the first in vitro diagnostic for minimal residual disease (MRD) monitoring in blood or bone marrow in patients with chronic lymphocytic leukemia (CLL). The assay provides standardized, accurate, and sensitive measurement of MRD, allowing physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission, and predict potential relapse.
The FDA clearance was previously approved for the assay in monitoring patients with multiple myeloma and acute lymphoblastic leukemia. The clonoSEQ is the first clinical diagnostic powered by immunosequencing to receive FDA clearance.
The FDA clearance was based on data from clinical trials evaluating clonoSEQ. In the CLL14 study, MRD was defined as having 1 cancer cell among 100,000 healthy cells. After 3 months, 337 patients with undetectable MRD in the blood by clonoSEQ showed nearly a sevenfold reduced risk of disease progression compared with patients who did not reach undetectable MRD. At 30 months posttreatment, the probability of disease progression was 5% in patients with undetectable MRD compared with 36% in patients with detectable disease. In addition, a second clinical trial found clonoSEQ MRD results to be predictive of outcomes in both blood and bone marrow samples, regardless of the threshold at which MRD was assessed.
