The US Food and Drug Administration (FDA) just announced that it will allow marketing of the first agency-authorized test for use with flow cytometry in order to help in the detection of several leukemias and lymphomas.
Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in an FDA press release, “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….This represents a major step forward for the hematology-oncology community” (June 29, 2017).
The FDA-validated test, ClearLLab Reagents (Ti, T2, B1, B2, M), specifically aids in the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
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The test is able to detect cancerous cells in the blood, bone marrow, and lymph nodes and can also tell clinicians what type of leukemia or lymphoma is present by marking proteins found on the surface of cells with fluorescent dyes.
Data for the ClearLLab test was reviewed through the de novo premarket review pathway, which is “a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.” Study results showed that the test aligned with the study site’s final diagnosis 93.4% of the time, and it correctly detected cancer presence (ie, cancer abnormality) 84.2% of the time.
The FDA is also establishing criteria, called special controls, along with this authorization. These special controls will clarify the agency’s expectations when it comes to the test’s accuracy, reliability, and clinical relevance.
Market authorization was granted to Beckman Coulter, Inc.—Amanda Del Signore