The first minimal residual disease (MRD) test in multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) has received coverage approval for Medicare patients. The MRD test called ClonoSEQ, from Adaptive Biotechnologies can detect lower levels of multiple myeloma than traditional tests.
MRD is a measurement of the remaining number of cancer cells that are present in a patient’s body during and after treatment and may eventually lead to recurrence of the disease. MRD testing is typically done after treatment to see how much disease is remaining.
The test can show if patients are MRD positive (cells are still detectable) and shows how many cells per million remain. The test can also show if a patient is MRD negative, or no myeloma cells remain. Clinical trials have shown that patients who become MRD negative after treatment generally have longer overall survival, so the test is important in predicting patient outcomes. More work needs to be done and more data needs to emerge to see if MRD testing can help doctors and patients decide when to stop therapy if they have had a deep response.
“Availability of sensitive, specific, and standardized MRD testing is increasingly crucial to the delivery of optimal patient care in both multiple myeloma and ALL,” Nikhil Munshi, MD, director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a statement. “Medicare coverage for the clonoSEQ Assay will help ensure that eligible patients across the U.S. have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care.”
MRD testing is now being done as part of clinical trials such as Sanofi’s Isatuximab.
“This is great news for patients,” said Charles Sang, senior vice president, Adaptive Diagnostics. “The establishment of favorable Medicare coverage for clonoSEQ soon after FDA authorization further demonstrates the clinical relevance of MRD assessment and underscores the benefit that this test delivers in the management of myeloma and ALL patients.”