NEW YORK (360Dx) – The US Food and Drug Administration on Thursday announced it allowed Beckman Coulter to market ClearLLab Reagents for the detection of several leukemias and lymphomas.
The test, the agency said, is the first authorized by it for use with flow cytometry to detect the cancers. The reagents OK'd by the FDA are ClearLLab B1 (B-cell tube 1), ClearLLab B2 (B-cell tube 2), ClearLLab T1 (T-cell tube 1), ClearLLab T2 (T-cell tube 2), and ClearLLab M (myeloid tube).
Beckman Coulter can market the test for use on flow cytometry-based testing for cancers such as chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. The ClearLLab test is used for detecting cancerous cells in blood, bone marrow, and lymph nodes, and can help laboratories and clinicians determine the type of leukemia and lymphoma present, the FDA said.
The test works by marking proteins found on cell surfaces with fluorescent dyes so that they can be analyzed by flow cytometry. The FDA used its de novo premarket review pathway — which is for novel, low- to moderate-risk devices that are not substantially equivalent to legally marketed devices already on the market — in order to make its decision.
A study was performed at four independent clinical sites to compare the ClearLLab test with other detection methods. Based on 279 samples, the test aligned with the study site's final diagnosis 93.4 percent of the time, and correctly detected the presence of cancer 84.2 percent of the time, the FDA said.
The agency said that it is establishing special controls for the test to assure its accuracy, reliability, and clinical relevance.
In a statement, Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said the FDA's decision is a "major step forward for the hematology-oncology community. Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers."