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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