The U.S. Food and Drug Administration (FDA) has approved a new laboratory test to help clinicians detect leukemia and lymphoma cells using a technique called flow cytometry.
The ClearLLab Reagents, developed by Beckman Coulter, was designed to specifically detect leukemia and lymphoma cells, recognizing markers characteristic of many malignancies, including chronic leukemia, acute leukemia, non-Hodgkin’s lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
“Laboratories and healthcare professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a news release.
“This represents a major step forward for the hematology-oncology community,” he said.
The ClearLLab test is a standardized kit that can be used with a technique known as flow cytometry. Flow cytometry involves the labeling of certain proteins with fluorescent antibodies. Some proteins are specific to a given cancer, and so labeling these proteins allows researchers to determine if a patient is likely to have a blood cancer and to identify the disease subtype.
The kit is composed of different reagents that combine fluorescent dyes with specific markers that will identify and attach to the cancer cells in a very consistent and accurate manner. Combined with flow cytometry, it allows for the detection and recognition of specific cell populations in different biological samples, including bone marrow, lymph nodes, or blood samples.
This is the first FDA-authorized test to be used in flow cytometry to help detect leukemias and lymphomas. ClearLLab test data was reviewed by the FDA through the risk-based and evidence-based de novo classification process.
The FDA’s decision was supported by the reliability and accuracy the test demonstrated on 279 samples analyzed at four independent clinical centers. In the study, researchers compared the results obtained by the use of the ClearLLab test with alternative cancer cell detection tests used in the clinical centers.
The researchers demonstrated the kit allowed the correct diagnosis 93.4 percent of the time, with an accuracy of detection of cancer cells of about 84.2 percent.
To assure the accuracy, reliability, and clinical relevance of this new diagnosis tool, the FDA is also establishing special controls. Together with common performance controls, these new controls will provide additional methods to guarantee the safety and effectiveness for ClearLLab Reagents and other similar tests to aid in the diagnosis of leukemias and lymphomas.