Medicare coverage has been announced for Adaptive Biotechnologies’ clonoSEQ® next-generation sequencing assay for the detection of minimal residual disease (MRD) after treatment for multiple myeloma or B-cell acute lymphoblastic leukemia (ALL) — a key step toward its use for patient care in cancer clinics in the United States.1,2The FDA announced regulatory approval for the assay in September 2018.3

“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 in Boston, Massachusetts, said in a press release.2 “Medicare coverage for the clonoSEQ Assay will help ensure that eligible patients across the US have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care.”

clonoSEQ assay quantifies DNA gene sequences from bone marrow at diagnosis, and can be used to monitor progress during therapy or post therapy. clonoSEQ reportedly can detect a single myeloma cell among 1 million cells.

It is “an important assay because it has significant sensitivity,” said Farhad Ravandi, MD, Janiece and Stephen A. Lasher Professor of Medicine and chief of section of developmental therapeutics in the department of leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas.

“It is certainly very useful,” Dr Ravandi told Cancer Therapy Advisor.“It will be very helpful for ALL and myeloma.”

Clinical trial data demonstrated clonoSEQ’s value as a measure of MRD negativity and depth of response, said Ajay K. Nooka,MD, MPH, FACP, an associate professor in the department of hematology and medical oncology at Emory University School of Medicine in Atlanta, Georgia. MRD negativity translated into progression-free survival and overall survival improvement, Dr Nooka told Cancer Therapy Advisor.

“One can make a case to achieve MRD negativity as a short-term end point with intent to gain long-term advantages,” Dr Nooka explained. “In this context, we are choosing more effective therapies that would lead us to achieving an MRD-negative status. However, a response-driven intensification of treatment to achieve MRD negativity or discontinuation of treatment upon achieving sustained MRD negativity is not the routine standard practice, currently.”