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# FDA Clears Next Gen Sequencing Assay
- URL: https://www.fdaweb.com/fda-clears-next-gen-sequencing-assay/
- Published: 2018-09-28T12:00:00.000Z
- Updated: 2026-09-15T00:34:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142475

FDA has cleared a de novo request to permit the marketing of Adaptive Biotechnologies’ ClonoSEQ assay, a next-generation sequencing-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia or multiple myeloma. An FDA release says MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow. “Measuring MRD provides a tool to detect very low levels of tumor burden,” it says. “MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients.”

Previously, healthcare providers have used flow cytometry assays or polymerase chain reaction-based assays to perform such tests. Those methods typically measure MRD down to 1 in 10,000 or 1 in 100,000 cells, FDA says. The ClonoSEQ assay measures MRD at levels below 1 in 1 million cells, it says.

  
FDA says it evaluated data to demonstrate clinical validity from a retrospective analysis of samples obtained from three previously conducted clinical studies. “Patients whose ClonoSEQ assay result was MRD negative have longer event-free survival, while patients with higher MRD assay results had lower event-free survival rates,” it says.