Rare Disease Report

FDA Approves Diagnostic Test for Rare Blood Cancers

JUNE 29, 2017
James Radke
The U.S. Food and Drug Administration (FDA) has approved Beckman Coulter’s ClearLLab Reagents (T1, T2, B1, B2, M) to be used with flow cytometry to help diagnose numerous rare blood cancers, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

The ClearLLab test not only detects cancerous cells in blood, bone marrow and lymph nodes, but also provides information on the type of leukemia or lymphoma.

The FDA marketing approval was based on a comparison of the test results from the ClearLLab Reagents with those from alternative detection methods at various clinical sites. The study found that the ClearLLab test results aligned with the study site’s final diagnosis 93.4% of the time and correctly detected a cancer 84.2% of the time.

Per the FDA, “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.”

The FDA is also establishing criteria (special controls), which clarify the agency’s expectations in assuring the test’s accuracy, reliability, and clinical relevance.

THe FDA advises that test results should be reviewed by a trained professional. 

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