Study Details Sensitivity of clonoSEQ Assay

Seattle-based Adapative Biotechnologies has released a study concluding that its clonoSEQ molecular assay is far more accurate in identifying relapses of b-cell acute lymphoblastic leukemia (B-ALL) compared to standard flow cytometry. B-ALL, a pediatric form of leukemia, is diagnosed in about 6,000 children in the United States every year. It is far more treatable than the adult form of the disease, and survival rates are higher if caught in a timely fashion and relapses are aggressively addressed. The clonoSEQ assay focuses on detecting minimal residual disease (MRD), considered an accurate predictor of relapse. According to a comparison test between clonoSEQ and the flow cytometry equipment at the University of Washington on 99 children with B-ALL 29 days after the first round of chemotherapy, the assay identified 28 relapses that flow cytometry did not catch. The presence of MRD was at levels 10 to 100 times lower than where both flow cytometry and clonoSEQ were able to accurately diagnose its presence. “Accurately measuring minimal residual disease is a critical component of patient care in acute leukemias,” said David Wu, M.D., an associate professor of laboratory medicine at the University of Washington. “Next-generation sequencing is a very promising technology that could greatly improve on current approaches.” The study was published in the online edition of the journal Clinical Cancer Research. Takeaway: Molecular assays are continuing to demonstrate far greater diagnostic sensitivities than many other forms of testing.