COMPANY:

Adaptive Biotech

"Adaptive Biotechnologies Corporation...today announced that clonoSEQ has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU)...clonoSEQ is now the first and only test to receive IVDR certification for the detection of minimal residual disease (MRD) in lymphoid malignancies. clonoSEQ’s intended use under IVDR is broad in scope, allowing for assessment of MRD status and changes in disease burden during and after treatment in patients diagnosed with B-cell malignancies...Additional technology transfer partnerships are expected to launch in the EU and surrounding markets later in 2024."

"In a Children’s Oncology Group-led study of pediatric patients with acute lymphoblastic leukemia (ALL), evidence from the largest analysis to date comparing bone marrow MRD assessment to peripheral blood MRD assessment with clonoSEQ showed a strong correlation between blood and marrow, independent of patient risk group. These data support the potential for a less invasive method to monitor MRD and track a patient’s response to therapy in ALL. In various stages of multiple myeloma (MM), real-world evidence and clinical trial results reinforced the clinical significance of sustained MRD negativity and importance of depth of response in predicting patient outcomes, including overall survival (OS) and progression-free survival (PFS), and illustrated how clonoSEQ could inform treatment discontinuation or de-escalation decisions."

"Adaptive Biotechnologies Corporation...announced new data demonstrating the expanding use of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® test in assessing minimal residual disease (MRD) in blood cancer patient care and in clinical trials. The data are being presented in more than 30 abstracts at the 65th Annual Meeting of the American Society of Hematology (ASH), December 9-12 in San Diego, California."

"Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, together with its collaborators will present data from more than 30 abstracts demonstrating the actionability of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ^® test in assessing minimal residual disease (MRD) in blood cancer patients at the 65th Annual Meeting of the American Society of Hematology (ASH), December 9-12 in San Diego, California."

"Adaptive Biotechnologies Corporation...today announced a multi-year, global translational collaboration with BeiGene to assess minimal residual disease (MRD) using clonoSEQ^® assay technology across the company’s pipeline of treatments for patients with lymphoid malignancies....This multi-year agreement will cover existing and future programs and adds to Adaptive’s growing list of translational collaborations with biopharmaceutical companies. As part of the collaboration, 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 BeiGene’s investigational medicines in patients with lymphoid malignancies. Adaptive will receive an upfront payment and will be eligible to receive future milestone payments upon achievement of specific regulatory milestones in certain geographies. Specific financial terms of the agreement will not be disclosed."

"Adaptive Biotechnologies Corporation...today announced that clonoSEQ® is now available to health care providers as a fully integrated test in Aura, Epic’s specialty diagnostics suite. This integration will allow providers to order and review clonoSEQ minimal residual disease (MRD) testing results in Epic as they would for any test performed directly at the site of care."

P2 | N=NA | "Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, will be included in several oral and poster presentations investigating the clinical significance of minimal residual disease (MRD) assessment at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago, as well as the European Hematology Association (EHA) Hybrid Congress taking place June 8-11 in Frankfurt, Germany....Final analysis from the multi-center Phase 2 MASTER trial showed that in newly diagnosed MM patients treated with quadruplet therapy and monitored using clonoSEQ, the three-year PFS was higher in patients with sustained MRD negativity compared to those who did not achieve MRD negativity."

"Adaptive Biotechnologies Corporation...announced it has entered into a translational collaboration with Takeda to use its clonoSEQ^® Assay to assess minimal residual disease (MRD) to facilitate the development and commercialization of Takeda’s pipeline of treatments for patients with lymphoid malignancies....As part of the collaboration, 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."

"Adaptive Biotechnologies Corporation...announced new data demonstrating the strengths of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay in measuring minimal residual disease (MRD) in blood cancer patients. The data are being presented at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10-13, 2022."

"Adaptive Biotechnologies Corporation...together with its collaborators, will present data from more than 30 abstracts showcasing the benefit of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ^® Assay in measuring minimal residual disease (MRD) in blood cancer patients at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10-13, 2022....Five of the presentations are studies using real-world evidence to demonstrate how serial clonoSEQ testing is being utilized in the clinic to inform physician decisions across indications and therapeutic regimens to guide personalized treatment plans, including discontinuation of therapy. Other presentations will highlight the value of utilizing clonoSEQ in clinical trials to assess and predict the effectiveness of investigational, novel therapeutics."

"Adaptive Biotechnologies Corporation...announced the launch of its clonoSEQ® Assay to detect minimal residual disease (MRD) in blood for patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma (NHL), affecting more than 100,000 people in the U.S. Because DLBCL is an aggressive but also potentially curable disease for many patients, disease monitoring plays a central role in patient management."

"Adaptive Biotechnologies Corporation...and HealthTree Foundation...announced findings from a new survey of 635 U.S. multiple myeloma patients which revealed important insights about the value of minimal residual disease (MRD) testing from the patient’s perspective. Notably, 96% of respondents who self-reported having used MRD testing found the testing useful or very useful. However, though the patients who have had an MRD test saw a clear clinical and emotional benefit from using this tool, 53% of all survey participants reported not using the test or were unsure if they had the test, underscoring the need for more education."

"Adaptive Biotechnologies Corporation...announced a partnership with Epic to integrate the clonoSEQ® Assay into Epic’s comprehensive electronic medical record (EMR) system...Epic integration will enhance the clonoSEQ customer experience by allowing providers to order and review clonoSEQ results from Adaptive in the same way as they would any test performed directly at the site of care."

"Adaptive Biotechnologies Corporation...announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its MolDX program, has expanded coverage of the clonoSEQ® Assay to include monitoring minimal residual disease (MRD) in Medicare patients with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL). This coverage determination is the first for clonoSEQ to include the assessment of MRD based on circulating tumor DNA (ctDNA), fragments of DNA released into the blood from lysed cancer cells."

"Data from Adaptive Biotechnologies Corporation...will be included in several abstracts investigating the impact of MRD in blood cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3-7, in Chicago, Illinois...Data using clonoSEQ for MRD assessment will be presented across a range of cancers including multiple myeloma, ALL, CLL and non-Hodgkin’s lymphoma (NHL) and underscore the significance of deep responses and identification of patients with better outcomes."

"Adaptive Biotechnologies Corporation...announced new data highlighting the clinical utility of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay to assess minimal residual disease (MRD) in patients with multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). The data are being presented at the American Society of Hematology (ASH) 63rd Annual Meeting and Exposition, held December 11-14 as a hybrid event, in Atlanta and virtually."

"Adaptive Biotechnologies Corporation...together with its collaborators will present data from more than 30 abstracts demonstrating the utility of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay in assessing minimal residual disease (MRD) in blood cancer patients at the 63rd Annual Meeting of the American Society of Hematology (ASH), December 11-14."

"Adaptive Biotechnologies Corporation...announced that Palmetto GBA’s Molecular Diagnostics Program (MolDX) has finalized a local coverage determination (LCD) which supports the Medicare coverage for clonoSEQ® to detect and monitor minimal residual disease (MRD) in patients with B-cell acute lymphoblastic leukemia (ALL), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL)."

"Adaptive Biotechnologies Corporation...announced today the launch of an enhanced version of its clonoSEQ® B-cell Clonality (ID) report, which will now feature the immunoglobulin heavy chain (IgH) – V mutation status for patients with chronic lymphocytic leukemia (CLL)...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."