The U.S. Food and Drug Administration (FDA) approved the marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first FDA-authorized test that can be used with flow cytometry to detect chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms.
The ClearLLab test can detect cancerous cells in the blood, bone marrow, and lymph nodes, and provides information on the type of leukemia or lymphoma. The test marks proteins found on the surface of cells with fluorescent dyes for further analysis via a flow cytometer.
The FDA granted the test marketing authorization through the agency’s de novo premarket review pathway. The decision was based on findings from a study comparing test results on 279 samples between the ClearLLab system and other detection methods used at four independent clinical sites. ClearLLab results aligned with the study sites’ final diagnoses 93.4 percent of the time, and the new system correctly detected cancer presence 84.2 percent of the time.
The FDA is establishing special controls for the test to ensure its accuracy, reliability, and clinical relevance.
The agency advises that trained professionals review results from the ClearLLab test.
Source: U.S. Food and Drug Administration news release, June 29, 2017.