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FDA allows marketing of test to help detect blood cancers
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The FDA today allowed marketing of a test that can be used with flow cytometry to help detect several types of blood cancer.
ClearLLab Reagents (T1, T2, B1, B2, M), developed by Beckman Coulter Life Sciences, is intended to aid in the detection of chronic and acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms.
The test — used to detect malignant cells in bone marrow, blood and lymph nodes — marks proteins found on the surface of cells with fluorescent dyes. A flow cytometer is used for further analysis.
“This represents a major step forward for the hematology–oncology community,” 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 press release. “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.”
The FDA based marketing authorization on results of a study conducted on 279 samples at four independent clinical sites. Researchers compared results of the ClearLLab Reagents test with those of alternative detection methods used at each site.
Results showed a 93.4% concordance rate between the ClearLLab Reagents results and the study site’s final diagnosis. The test correctly detected the presence of cancer in 84.2% of cases.