FDA Approves Leukemia, Lymphoma Detection Test

The FDA recently authorized the marketing of the ClearLLab Reagents (T1, T2, B1, B2, M) test, which aids in the detection of leukemias and lymphomas.

The test is approved for use with flow cytometry to diagnose chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN), according to a press release.

Leukemia originates in immature blood cells, which outnumber healthy blood cells in the bone marrow. This is the most common form of cancer among children and is also common among adults over age 55. Lymphoma begins in the cells of the lymphatic system, which plays an important part in warding off disease.

The ClearLLab test can detect cancer cells in the blood, bone marrow, and lymph nodes by marking proteins with florescent dyes. The marked cells then go on to receive further analysis on a flow cytometer. The test also provides information about the subtype of leukemia or lymphoma, which can help determine treatment approaches, the release noted.

The FDA reviewed data for the test through the de novo premarket review pathway, which is for low-to-moderate risk devices that are not equivalent to previously marketed devices.

The approval of the ClearLLab test was supported by a trial that studied the efficacy of the test in 279 samples. The results from the ClearLLab test were compared with results from alternative detection methods.

The investigators discovered that the test results aligned with the final diagnosis 93.4% of the time and correctly detected cancer 84.2% of the time, according to the release.

Along with marketing approval, the FDA is creating special controls to outline the expectations of the test’s accuracy, reliability, and clinical relevance, according to the release. The special controls plus general controls provide reasonable safety and efficacy assurance for patients.

The FDA noted that results from the newly-approved ClearLLab test must be reviewed by a healthcare professional to ensure the accuracy of the conclusions.

“This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, PhD, 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.”