FDA Clears Test to Help Diagnose, Identify Blood Cancer Type

The US Food and Drug Administration (FDA) has approved the marketing of a new lab test used with flow cytometry to aid in the detection of several hematologic malignancies-including acute and chronic leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, multiple myeloma, and non-Hodgkin lymphoma.

The new test, ClearLLab Reagents (T1, T2, B1, B2, M), can detect cancerous cells in the blood, bone marrow, and lymph nodes-and uses fluorescent dyes to mark cell-surface proteins for further analysis with flow cytometry-providing laboratories information about what type of blood cancer is present.

“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, in a 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.”

The approval of the test was based on a study that compared the test’s results to current methods of cancer detection. The study was conducted on 279 samples at four, independent sites and showed that the results of the test aligned with each study site’s final diagnosis 93.4% of the time and detected the presence of cancer 84.2% of the time.

The FDA notes that a trained professional must review the results of the test.

Along with this authorization, the FDA will establish special controls to clarify the FDA’s expectations in assuring that the test is reliable, accurate, and clinically relevant.

These special controls are intended for ClearLLab Reagents and other tests used in the diagnosis of hematologic malignancies. The special controls also detail the best regulatory pathway for future developers of similar diagnostic tests for hematologic malignancies.