The FDA recently allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
The ClearLLab test is used to detect cancerous cells in blood, bone marrow, and lymph nodes, and it also provides laboratories and clinicians with information about what type of leukemia or lymphoma is present. It works by marking proteins found on the surface of cells with fluorescent dyes for further analysis on an instrument known as a flow cytometer.
The FDA reviewed data for the ClearLLab test through the de novo premarket review pathway. Its authorization was supported by a study conducted on 279 samples at four, independent clinical sites comparing the test's results to alternative detection methods used by the clinical sites. The study showed the results of the test aligned with the study site's final diagnosis 93.4 percent of the time and correctly detected there was a cancer presence (i.e., cancer abnormality) 84.2 percent of the time.