Beckman Coulter has been authorized to market its ClearLLab Reagents (T1, T2, B1, B2, M) tests for use with flow cytometry to detect leukemias, lymphomas, and myeloproliferative disorders in blood, bone marrow, and lymph nodes, according to the U.S. Food and Drug Administration.
As the tests were not substantially equivalent to an already existing test and are low to moderate risk, the FDA reviewed them through its de novo premarket review pathway.
A study evaluating the efficacy of the test compared the test results (n = 279) with clinical evaluations at four independent clinical sites. The results matched the diagnoses 93.4% of the time and correctly detected cancer 84.2% of the time.
“This represents a major step forward for the hematology-oncology community,” Alberto Gutierrez, PhD, of the FDA’s Center for Devices and Radiological Health said in the FDA’s 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.”
The approval coincides with criteria for ongoing evaluation of the ClearLLab tests and approval of future tests. The release notes that the ClearLLab test results must be reviewed by a trained professional.
