FDA Clears ClonoSEQ Assay for Measuring Minimal Residual Disease in Myeloma, Leukemia

The U.S. Food and Drug Administration (FDA) has approved Adaptive Biotechnologies’ clonoSEQ Assay to detect and monitor minimal residual disease (MRD) — the small number of cancer cells that remain in a patient’s body during and after treatment — in patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL).

The approval makes clonoSEQ the first FDA-cleared assay for MRD assessment in any blood cancer.

“The FDA clearance of clonoSEQ is an important advance for patients with [multiple myeloma] and ALL and for the oncologists who care for them. This milestone underscores the importance of MRD as a predictor of patient outcomes,” Aaron Logan, MD, PhD, associate professor of the Division of Hematology and Blood and Marrow Transplant at the University of California, San Francisco, said in a press release.

“Quantification of MRD should be standard practice to assess response to treatment, monitor disease progression and direct patient care. It is thus essential to have an MRD assay that meets regulatory standards and can accurately and reliably measure and track disease burden over time,” he said.

In blood cancers, MRD refers to a small number of cancer cells that remain in the body after treatment is complete and may lead to relapse. But these cells can be present at very low levels and be undetectable by traditional methods. Thus, researchers need highly sensitive tests that help them monitor disease burden, guide treatment decisions, and improve patient outcomes.

Adaptive’s clonoSEQ Assay is a diagnostic tool that uses next-generation DNA sequencing (NGS) to simultaneously evaluate the unique genetic patterns of B- and T-cell receptors in a single bone marrow sample.

Recently, the FDA included MRD on the list of surrogate endpoints that could be used in clinical trials to demonstrate the therapeutic activity of new agents. These advances have made clear the need of an accurate and standardized method that could be used to measure MRD.

“As MRD is increasingly used to inform treatment decisions, the importance of having an accurate and standardized assessment method becomes paramount,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “NGS MRD testing is already part of National Comprehensive Cancer Network (NCCN) treatment guidelines for patients with [multiple myeloma] MM, ALL, and [chronic lymphocytic leukemia], and clonoSEQ is already in use for patient management in the majority of NCCN cancer centers, further demonstrating the clinical importance of MRD and acceptance of NGS MRD testing by the oncology community.”

“Adaptive is working diligently with public and private payers to make clonoSEQ broadly available to patients in need,” he said.

Adaptive has established collaborations with Amgen, Sanofi, and other pharmaceutical companies for the use of clonoSEQ Assay to assess MRD in patients with multiple myeloma and ALL in undergoing clinical trials.

“Now, physicians and patients will have access to the first FDA-cleared MRD assay, providing them with another important tool to make informed decisions about treatments to help achieve MRD negativity,” Greg Friberg, MD, vice president of Global Development, Oncology at Amgen. “We look forward to continuing our collaboration with Adaptive Biotechnologies to further explore MRD and deliver on our mission to serve patients through transformative science.”