FDA Approves NGS-Based Test That Detects Very Low Levels of Cancer Cells in ALL or MM

A test that uses next-generation sequencing (NGS) has been approved to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). The clonoSEQ Assay assesses disease burden to predict treatment outcomes, guide management decisions, and improve patient care.

Gottlieb called the approval an “important step forward for patients suffering from ALL and multiple myeloma.”

Approximately 6000 people in the United States will be diagnosed with ALL and 31,000 will be diagnosed with MM in 2018, according to FDA. MRD refers to very low levels of remaining cancer cells remaining after treatment. Despite causing no symptoms, these residual cells can lead to a recurrence of the disease and can only be identified by highly sensitive tests.

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“Determining whether a patient has residual cancer cells remaining after treatment provides information on how well a patient has responded to therapy and how long remission may last,” Gottlieb said in a statement. “Having a highly sensitive test available to measure minimal residual disease in ALL or multiple myeloma patients can help providers manage their patients’ care. The FDA is applying novel regulatory approaches to make sure that these rapidly evolving NGS tests are accurate and reliable.”

The FDA reviewed clonoSEQ assay through the de novo premarket review pathway, for novel, low- to moderate-risk devices. The agency used samples from 3 clinical trials including 273 patients with ALL, an ongoing trial of 323 patients with MM, and another study of 706 patients with MM. ClonoSEQ found that MRD level correlated with event-free survival in patients with ALL. Patients with a negative result had longer event-free survival, while patients with a higher MRD assay result had lower event-free survival. In patients with MM, the assay showed similar associations with progression-free survival and disease-free survival.

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