Starting today, all clonoSEQ B-cell Clonality (ID) reports will automatically include IGHV mutation status. IGHV mutation status has been shown to be prognostic of outcomes in CLL, with mutated IGHV genes inferring better outcomes. Guidelines from both the National Comprehensive Cancer Network (NCCN) and the
“clonoSEQ is a tool I utilize often to assess MRD status in my patients that require time limited therapy for CLL, not only because it is valuable for helping predict potential relapse or survival but also because it informs my patient management,” said
MRD describes the small number of cancer cells that remain in the body during and after treatment. MRD assessment with clonoSEQ 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 detect potential relapse. Evidence generated in CLL clinical trials (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.
“The inherent design of the clonoSEQ Assay enables assessment of a patient’s IGHV mutation status and identification of the trackable sequences we use to monitor their MRD at the same time, so it was a natural evolution for us to make,” said
The test for IGHV mutation status is a CLIA-validated lab-developed test (LDT) and an additional feature of the clonoSEQ assay provided at the time of diagnosis. clonoSEQ IGHV mutation status is not FDA cleared or approved. Access to clonoSEQ for CLL patients nationwide is supported by the already-established Medicare coverage of clonoSEQ in CLL.
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. clonoSEQ patients can access minimal-contact blood collection services at any of the nearly 2,000
About the clonoSEQ Assay
The clonoSEQ Assay is the first and only FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and B-ALL using DNA from bone marrow samples. In
The clonoSEQ Assay 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.
The clonoSEQ Assay is a single-site test performed at
About
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 three 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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