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clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.
Adaptive Biotechnologies Corporation announced on April 12, 2023 that it has begun a translational collaboration with Takeda. Adaptive Biotechnologies will use its clonoSEQ Assay to assess minimal residue disease (MRD) to start with the development and commercialization of Takeda’s pipeline of treatments for patients with lymphoid malignancies, according to the press release.
“We are thrilled to enter into a broad translational collaboration with Takeda incorporating the use of our clonoSEQ Assay technology in clinical trials to support the clinical development of groundbreaking oncological therapies,” said Nitin Sood, chief commercial officer, MRD at Adaptive Biotechnologies, in a press release. “MRD is an important measure of whether novel treatments are inducing effective and durable responses for patients, and its use as an endpoint is rapidly growing.”
The first and only next-generation sequencing-based MRD test, clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment. It is also the first FDA-cleared in-vitro diagnostic test service to detect MRD in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia, and blood or bone marrow from patients with chronic lymphocytic leukemia.
“Innovative technology plays a critical role in informing our clinical development plans as we look to bring effective new medicines to patients with hematologic malignancies,” said Christine Ward, Head, Precision and Translational Medicine, Oncology Therapeutic Area Unit (OTAU) at Takeda, in a press release. “This collaboration with Adaptive allows us to further explore the clinical relevance of MRD as we progress our pipeline of investigational medicines.”
MRD status based on Adaptive’s clonoSEQ Assay may be used as an endpoint in certain clinical trials to assess the depth and duration of response to Takeda’s investigational medicines in patients with lymphoid malignancies. The multi-year agreement will cover existing and future programs and adds to Adaptive’s growing list of translational collaborations with pharmaceutical companies, according to the press release.
Source: Adaptive Biotechnologies