Clinicians increasingly recognize the value of minimal residual disease (MRD) testing for assessing treatment response among patients with myeloma. But a newly released survey of clinical testing in institutions across the United States finds that widely divergent methodologies remain a continuing challenge.1
According to the authors of an article recently published in the American Journal of Hematology:
“MRD negativity by flow cytometry (FC) is consistently associated with improved progression-free and overall survival. This has prompted the [US] Food and Drug Administration (FDA) to state that FC-MRD, if appropriately validated and standardized, could be used as a surrogate end point biomarker in clinical trials evaluating novel therapies.”
Corresponding author Ola Landgren, MD, PhD, of the Memorial Sloan Kettering Cancer Center in New York, New York, said in a telephone interview that limited access to efficient, effective, and easy-to-use diagnostic technologies may hinder those efforts.
“One of the technical problems in this country and outside this country is that technologies that are available for clinicians to determine MRD status in a clinical setting are a little bit limited,” he said. “I have been worried that if we don’t help and improve people’s access to technology, that’s going to slow down the whole process.”
The article presents the results of a new survey of leading myeloma centers in the country, compared to the findings of a similar survey released in 2013.
Aimed at evaluating “progress in FC methodology and the developing role of molecular MRD (M-MRD) testing for myeloma,” the survey found positive signs of improvement. Six out of 14 laboratories (42.9%) achieved a limit of detection of 0.001% or better, it reported, “in contrast to only 2/11 (18.2%) in 2013.”