The U.S. Food and Drug Administration (FDA) has authorized the next-generation sequencing (NGS)–based clonoSEQ assay for the measurement of minimal residual disease (MRD) in patients with acute lymphocytic leukemia (ALL) or multiple myeloma (MM). This is the first NGS-based test approved for this purpose.
The FDA’s approval was based on results from a retrospective analysis of three separate studies comprising 273 patients with ALL, 323 patients with MM, and 706 patients with MM, respectively. In patients with ALL, negative MRD results detected by the clonoSEQ assay were correlated with higher event-free survival rates; in patients with MM, negative results were associated with higher progression-free and disease-free survival rates (p values not provided).
The clonoSEQ assay identifies and quantifies gene sequences extracted from patient DNA and can measure MRD down to 1 in 1 million cells (<10-6), while previously available methods measured MRD down to 1 in 10,000 (<10-4) or 1 in 100,000 cells (<10-5).
“Having a highly sensitive test available to measure MRD in [patients with] ALL or MM can help providers manage their patients’ care,” FDA Commissioner Scott Gottlieb, MD, said in a press release announcing the approval. “The FDA is applying novel regulatory approaches to make sure that these rapidly evolving NGS tests are accurate and reliable.”