29 June 2017 - The U.S. FDA today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorised test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukaemia, acute leukaemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms.

“This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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.”

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