First FDA-Approved Test to Help Detect Several Leukemias and Lymphomas

Web Exclusives - FDA Approvals, News & Updates

On June 29, 2017, the FDA authorized the marketing of ClearLLab Reagents (from Beckman Coulter, Inc), the first test that is agency approved to aid flow cytometry in the marking and detecting of several blood cancers, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.

The ClearLLab test, which uses a fluorescent dye to mark proteins on the surface of cells for further analysis with a flow cytometer, identifies cancerous cells in blood, bone marrow, and lymph nodes, and gives clinicians information about the type of leukemia or lymphoma that is present.

“This represents a major step forward for the hematology-oncology community. 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,” said Alberto Gutierrez, PhD, Director of the FDA Center for Devices and Radiological Health.

The ClearLLab test approval was based on a study showing that the ClearLLab test’s results accurately detected the presence of cancer 84.2% of the time.

The FDA notes that ClearLLab Reagents test results must be reviewed by trained professionals.

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Last modified: August 10, 2017
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