The Food and Drug Administration (FDA) has approved Beckman Coulter’s ClearLLab Reagents (T1, T2, B1, B2, M), making this the first flow cytometry test designed to help detect a variety of leukemias and lymphomas. The assay is a 10-color reagent screen designed to detect cancerous cells in peripheral whole blood, bone marrow, and lymph node specimens. It also distinguishes between a variety of cancers such as chronic leukemia, non-Hodgkin lymphoma, and myeloma.
FDA reviewed ClearLLab Reagents through the de novo premarket pathway and supported its authorization with a study that evaluated the test’s performance. The study, conducted on 279 samples across four independent clinical sites, compared results obtained with the test to other detection methods. The results showed that the assay correctly identified a cancer presence 84.2% of the time and aligned with the clinical site’s final diagnosis 93.4% of the time.