Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia
- First and only FDA-cleared assay for MRD in CLL, multiple myeloma and ALL
- CLL clearance includes testing in blood; Adaptive collaborating with LabCorp® and Phlebotek Solutions® to provide clonoSEQ patients convenient options and safe access to blood draws at home or at
LabCorp Patient Service Centers
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Access to clonoSEQ for CLL patients 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. Medicare coverage is critically important in CLL, as nearly 80 percent of patients living with CLL in the
“FDA clearance of clonoSEQ, which can detect one single cancer cell among a million healthy cells, is an important milestone for the CLL community,” said Dr.
FDA clearance of clonoSEQ in CLL was based on clinical validation data from two important clinical trials:
- In an analysis of data from the CLL14 study (n=337), patients with undetectable MRD in blood by clonoSEQ at three months post-treatment had a nearly seven-fold reduced risk of disease progression compared with patients who did not reach undetectable MRD. For purposes of this analysis, an undetectable MRD was defined at a level of 1 cancer cell among one hundred thousand healthy cells (10-5).
- Additional evaluation of the data showed that at 30 months post-treatment, the probability of disease progression for evaluable patients with undetectable MRD was only 5%, as compared to 36% for patients with detectable disease.
- In a second study by Thompson et al, clonoSEQ MRD results were shown to be significantly predictive of outcomes in both blood and bone marrow samples, regardless of the threshold at which MRD was assessed.
MRD refers to the remaining number of cancer cells that are present in a patient’s body during and after treatment, which may eventually lead to recurrence of the disease. MRD assessment is performed as a series of tests throughout a patient’s cancer journey to evaluate prognosis, determine response to treatment, monitor disease during remission and predict potential relapse. Controlled trials in CLL as well as other blood cancers have shown that even the smallest amounts of residual disease can predict a patient’s long-term clinical outcomes. As novel therapies make deeper and more durable responses achievable for many blood cancer patients, clinicians are increasingly utilizing MRD results to help guide day-to-day patient management.
“We know that traditional CLL treatment response criteria are insufficient, so the ability to measure MRD with a test that is one hundred times more sensitive than standard flow cytometry may change our approach to treating CLL,” said Dr.
The availability of clonoSEQ testing in blood will facilitate ease of testing for CLL patients, but as the COVID-19 pandemic continues, some patients may be unable to or may feel anxious about obtaining a blood draw in a hospital or clinic. To address this, Adaptive has launched a service offering which will enable clonoSEQ patients to safely obtain blood draws in alternate settings. Patients can either access minimal-contact blood collection services at any of the nearly 2,000
“The FDA clearance of clonoSEQ in CLL represents a significant advancement for patients with CLL,” said
About the clonoSEQ Assay
Prior to CLL, the clonoSEQ Assay was granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. 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. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL.
clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.
About Chronic Lymphocytic Leukemia (CLL)
CLL is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). It is one of the most common types of leukemia in adults. The disease often occurs during or after middle age, with the average age of diagnosis at 70 years old. There were more than 20,000 new cases of CLL in the
Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics, and drug discovery. We have two commercial products, and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. For more information, please visit adaptivebiotech.com and follow us on www.twitter.com/adaptivebiotech.
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Source: Adaptive Biotechnologies