FDA Approves Lab Test to Help Detect Myeloma

The U.S. Food and Drug Administration (FDA) recently approved a lab test to aid in the detection and diagnosis of myeloma and a range of other blood cancers.

The ClearLLab Reagents test now becomes the first FDA-authorized assessment for use with a method called flow cytometry to detect blood cancers, including chronic leukemia, acute leukemia, non-Hodgkin’s lymphoma, myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN).

“This represents a major step forward for the hematology-oncology community,” 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 a press release.

“Laboratories and healthcare professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers,” he added.

Flow cytometry is a method commonly used in research or diagnostic procedures to identify specific cell types. The ClearLLab Reagents test work by labeling various molecules — present on the surfaces of cancer cells — with fluorescent dyes. These are then detected by the flow cytometry equipment.

The test can be used to look for cancer cells in blood samples, bone marrow, and lymph nodes and will not only provide information that cancer is present, but will also indicate what type of cancer a patient is likely to have.

The approval was based on a study in which the test was assessed using 279 tissue samples at four clinics. The ClearLLab Reagents test results were compared to results obtained by other detection methods used at the cancer clinics.

In 93.4 percent of cases, the results were in agreement with the patient’s final diagnosis. It correctly identified cancer in 84.2 percent of samples.

The FDA cautioned that test results should be reviewed by a person trained in the use of the method.

According to the American Cancer Society, a myeloma diagnosis currently involves a number of different tests, including counting various types of blood cells and quantifying certain types of antibodies and other molecules in the blood and urine. X-rays and bone marrow samples are also commonly performed.

The test is produced by Beckman Coulter.