NEW YORK – Adaptive Biotechnologies announced on Thursday that its blood-based ClonoSeq assay has received expanded coverage from Medicare administrative contractor Palmetto GBA for the detection and monitoring of measurable residual disease in patients with mantle cell lymphoma (MCL).
The test can be used to assess response, understand prognosis, and monitor patients to detect molecular recurrence before clinical or radiographic relapse, Adaptive said in a statement. The expanded coverage policy extends to all patients with MCL, regardless of line of therapy or treatment regimen. Adaptive noted that ClonoSeq episode pricing across all of its currently covered indications is up to $8,029.
The assay uses Adaptive's proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells.
"In an incurable disease such as MCL, implementing ClonoSeq MRD assessment is essential not only to identify those patients at high risk of relapse but also for advancing patient-centric treatment interventions and multi-modal monitoring strategies," Ben Eckert, senior VP for market access at Adaptive, said in a statement.
The coverage decision "will enable further integration of this important tool into lymphoma care pathways and ultimately improve outcomes for patients," he added.
ClonoSeq is currently covered for cellular DNA-based MRD testing in multiple myeloma, chronic lymphocytic leukemia, and B-cell acute lymphoblastic leukemia, as well as for circulating tumor DNA-based MRD testing in diffuse large B-cell lymphoma. ClonoSeq testing for patients with MCL is available as a laboratory-developed test performed at Adaptive's CLIA-certified laboratory in Seattle.
ClonoSeq is cleared by the US Food and Drug Administration and received Class C certification under Europe's In Vitro Diagnostic Regulation earlier this year.