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FDA Approves Test to Detect Cancerous Cells in Blood

FDA news release; 2017 Jun 29

Publish date:: July 5, 2017

The FDA has approved ClearLLab reagents (T1, T2, B1, B2, M) for use with flow cytometry to aid in the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.

Indications: The ClearLLab test is used to detect cancerous cells in blood, bone marrow, and lymph nodes, and provides information about leukemia/lymphoma type. It works by marking proteins found on the surface of cells with fluorescent dyes for further analysis via flow cytometry.

Efficacy and safety: Approval is based on results of a study comparing the test’s results to alternative detection methods. Test results aligned with the study site’s final diagnosis 93% of the time and correctly detected cancer 84% of the time.

Citation:

FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas. [news release]. Silver Spring, MD: FDA. June 29, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565321.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed July 2, 2017.

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