The Food and Drug Administration on Thursday granted market clearance to Beckman Coulter's test to aid clinicians in the detection of several blood and lymphatic cancers.
The ClearLLab test marks cell proteins with fluorescent dyes, which clinicians can further analyze on a flow cytometer instrument. The test detects cancerous cells in blood, bone marrow or lymph nodes and provides information about what type of leukemia or lymphoma is detected.
"This represents a major step forward for the hematology-oncology community," said Alberto Gutierrez, PhD, director of the FDA's Office of In Vitro Diagnostics. "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."
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