Adaptive Biotechnologies Announces Collaboration with GSK to Measure Minimal Residual Disease with clonoSEQ® Assay Across its Hematology and Oncology Portfolio
“We are thrilled to collaborate with GSK to implement our leading MRD test across their groundbreaking hematology portfolio as a measure of treatment response and patient outcomes,” said
In hematologic malignancies, MRD testing can be used to see if a patient is responding to treatment or if the cancer has come back. It is performed as a series of tests throughout a patient’s cancer journey. The clonoSEQ Assay is the first and only next-generation sequencing (NGS)-based MRD test authorized by the FDA to detect and monitor MRD in multiple myeloma, chronic lymphocytic leukemia and B-cell acute lymphoblastic leukemia.
As part of the non-exclusive, pan-portfolio translational collaboration, Adaptive’s clonoSEQ Assay also may be used in GSK hematology clinical trials to generate data supporting the clinical value of monitoring MRD in the context of patient care.
Adaptive will receive upfront and potential future regulatory milestone payments in certain geographies. Specific financial terms of the agreement will not be disclosed.
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 Adaptive Biotechnologies. In addition to its FDA-cleared uses, clonoSEQ is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers and sample types. 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.
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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Carrie Mendivil, Gilmartin Group
Source: Adaptive Biotechnologies