The National Comprehensive Cancer Network on Monday updated its Clinical Practice Guidelines for Multiple Myeloma to establish a framework for minimal residual disease assessment, adding a new dedicated page outlining principles of MRD testing.
The guidelines recommend bone marrow-based MRD assessment using next-generation sequencing with an FDA-approved assay or multicolor flow cytometry. clonoSEQ, an FDA-cleared in vitro diagnostic test from Adaptive Biotechnologies Corp., was the only assay specifically mentioned in the updated guidelines.
The preferred sensitivity for MRD testing is 10^-6, described as providing a more precise understanding of the depth of response, with a minimum recommended sensitivity of 10^-5. Recommended timepoints for MRD assessment were expanded to include annual testing during maintenance and after later lines of therapy, including after CAR T-cell therapy.
MRD negativity and sustained MRD negativity can help guide treatment escalation, de-escalation, and maintenance therapy as part of shared decision-making with patients. Rising MRD positivity may prompt closer monitoring and clinical evaluation.
"Greater sensitivity matters, as it is associated with clinical outcomes, and assessing MRD at a sensitivity of 10^-6 gives us a more precise understanding of the depth of response," said Ola Landgren, director of the Sylvester Myeloma Institute at Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine.
clonoSEQ is approved for detecting and tracking minimal residual disease in patients with multiple myeloma or B-cell acute lymphoblastic leukemia using bone marrow, and chronic lymphocytic leukemia using blood or bone marrow. Medicare covers the test for multiple myeloma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and mantle cell lymphoma.
Shares of Adaptive Biotechnologies closed at $24.78 on Sept. 14, up 2.4%, and traded at $25.00 in after-hours trading on Sept. 16.
