FDA Clears clonoSEQ Assay to Evaluate MRD in Patients with CLL

The FDA cleared the clonoSEQ assay to detect and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.

The FDA cleared the clonoSEQ assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL), according to Adaptive Biotechnologies, the developer of the assay.

The clonoSEQ assay is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL. This adds to the existing uses of clonoSEQ, as the FDA previously granted the assay De Novo designation for the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) patients.

“FDA clearance of clonoSEQ, which can detect one single cancer cell among a million healthy cells, is an important milestone for the CLL community,” Brian Koffman, MD, chief medical officer and executive vice president of the CLL Society, Inc., said in a press release. “Looking with greater accuracy for persistent cancer cells can show how well treatment is working and may help inform important decisions such as changing or stopping therapy. In my own CLL journey, knowing my clonoSEQ MRD status has impacted the way my expert team of doctors and I manage my disease.”

Notably, clonoSEQ is the first clinical diagnostic powered by immunosequencing to receive FDA clearance. According to Adaptive, the assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission, and predict potential relapse.

In CLL specifically, clearance of clonoSEQ was based on clinical validation from 2 clinical trials.

“We know that traditional CLL treatment response criteria are insufficient, so the ability to measure MRD with a test that is 100 times more sensitive than standard flow cytometry may change our approach to treating CLL,” John Pagel, MD, PhD, principal investigator and chief of Hematologic Malignancies at the Swedish Cancer Institute, said in the release. “A patient’s MRD status gives us timely information about how a treatment is working, so patients and providers can be in the driver’s seat when it comes to managing their disease and treatment decisions.”

In the CLL14 study, which included 337 participants, patients with undetectable MRD in blood by clonoSEQ at 3 months post-treatment had a nearly 7-fold reduced risk of disease progression compared with those who did not reach undetectable MRD. For the purpose of this analysis, an undetectable MRD was defined at a level of 1 cancer cell among 100,000 healthy cells (10-5). Further evaluation of the study data also demonstrated that at 30 months post-treatment, the probability of disease progression for evaluable patients with undetectable MRD was only 5%, compared to 36% for those with detectable disease.

In a second study by Thompson et al, the clonoSEQ MRD results were found to be significantly predictive of outcomes in both blood and bone marrow samples, regardless of the threshold at which MRD was analyzed.

Importantly, access to clonoSEQ for patients with CLL nationwide is supported by the already-established Medicare coverage of clonoSEQ in CLL, as well as by the FDA’s clearance of clonoSEQ testing for CLL patients in blood and marrow. In addition, due to the coronavirus disease 2019 (COVID-19) pandemic, Adaptive has also launched a service offering which will allow patients using clonoSEQ to safely obtain blood draws in alternate settings.

“The FDA clearance of clonoSEQ in CLL represents a significant advancement for patients with CLL,” Lance Baldo, MD, chief medical officer of Adaptive Biotechnologies, said in the release. “We believe this first-time clearance for clonoSEQ in blood will be advantageous for both providers and patients. Given the risks that COVID-19 poses for cancer patients, we are proud to be collaborating with 2 best-in-class service providers to offer clonoSEQ patients flexible and safe options for blood sample collection outside of a hospital or clinic.”


Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia [news release]. Seattle. Published August 6, 2020. globenewswire.com/fr/news-release/2020/08/06/2074302/0/en/Adaptive-Biotechnologies-Receives-Expanded-FDA-Clearance-for-the-clonoSEQ-Assay-to-Assess-Minimal-Residual-Disease-MRD-in-Patients-with-Chronic-Lymphocytic-Leukemia.html. Accessed August 6, 2020.

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