The Food and Drug Administration (FDA) has granted marketing approval of Beckman Coulter’s ClearLLab Reagents (T1, T2, B1, B2, M), the first test for use with flow cytometry to help detect certain leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN).
The ClearLLab test is intended to identify malignant cells in the blood, bone marrow, and lymph nodes. The data informs labs and clinicians on the type of leukemia or lymphoma present by marking proteins found on the surface of cells with fluorescent dyes. These markers are further analyzed on a flow cytometer.
Through the ;de novo premarket review pathway, the FDA evaluated study data that showed the test’s performance on 279 samples across four clinical sites. In the study, the results from ClearLLab Reagents were compared to alternative detection methods used by the clinical sites. The test results were in line with the study’s final diagnosis 93.4% of the time and correctly detected the presence of cancer 84.2% of the time.
In addition to the marketing authorization, the FDA has established “special controls,” a set of criteria that clarify the Agency’s standards regarding a test’s accuracy, reliability, and clinical relevance. When the special controls along with general controls are met, there is reasonable assurance of the test’s safety and efficacy used to aid in the diagnosis of leukemias and lymphomas.
For more information call (800) 742-2345 or visit Beckman.com.