Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at CDRH called it a “major step forward for the hematology-oncology community”. FDA is allowing Beckman Coulter to market the first agency-authorized test to help detect many forms of leukemia and lymphomas, including chronic and acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms. Leukemia is a blood cancer that primarily affects adults 55 and older, and is the most common cancer in children younger than 15 years.
Called ClearLLab Reagents (T1, T2, B1, B2, M), the test marks proteins on the surface of cells with fluorescent dyes for analysis on a flow cytometer. It can detect cancer cells in blood, bone marrow and lymph nodes, as well as indicate the type of leukemia or lymphoma.
The FDA review process occurred via the de novo premarket review pathway. The authorization of the test was supported by a study comparing the test’s results to alternative detection methods used by clinical sites. In addition to the authorization, the agency is establishing special controls that explain its expectations for ensuring the reliability, accuracy and clinical relevance of the test.