FDA has granted its first-ever authorization for a test that uses flow cytometry to aid in the detection of several leukemias and lymphomas.

Staff Report

FDA has given Beckman Coulter permission to sell its ClearLLab Reagents, the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas. FDA reviewed data for the test through the de novo premarket review pathway, which is designed for low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. 

The ClearLLab test is designed to detect cancerous cells in blood, bone marrow, and lymph nodes. It also provides laboratories and clinicians with information about what type of leukemia or lymphoma is present, FDA noted. It works by marking proteins found on the surface of cells with fluorescent dyes for further analysis on a flow cytometer.

"This represents a major step forward for the hematology-oncology community," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health, which is part of FDA's Center for Devices and Radiological Health. "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."

The agency's authorization of the ClearLLab was supported by a study designed to demonstrate the test's performance, which was conducted on 279 samples at four, independent clinical sites. The study compared the test's results to alternative detection methods used by the clinical sites. The study showed that the results of the test aligned with the study site's final diagnosis 93.4% of the time, and correctly detected a cancer presence 84.2% of the time.

This authorization, through new special controls FDA is establishing along with it, opens a regulatory door for future developers of similar tests for leukemias and lymphomas.

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