Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts on Utility of clonoSEQ® in MRD Testing in Blood Cancer Patients at the 63rd ASH Annual Meeting

SEATTLE, Dec. 02, 2021 (GLOBE NEWSWIRE) — 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 utility of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ^® Assay in assessing minimal residual disease (MRD) in blood cancer patients at the 63^rd Annual Meeting of the American Society of Hematology (ASH), December 11-14.

clonoSEQ is the only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-ALL), and is widely available to clinicians and patients across the U.S.

“The data presented at ASH continues to build on evidence supporting the clinical value of serial MRD testing across blood cancers to help hematologists guide patient management, including the decision to stop treatment,” said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. “In both clinical trial and real-world settings, clonoSEQ has consistently demonstrated how NGS MRD assessment can meaningfully enhance the way patients and their clinicians understand and manage blood cancers.”

MRD assessment is a way to directly detect and quantify remaining disease during and after treatment. With clonoSEQ, clinicians can leverage a precise and reliable technique that can detect as little as one cancer cell among a million healthy cells with sufficient input material. This high sensitivity gives clinicians valuable insight into the dynamics of a patient’s disease, which can help predict outcomes, assess response, monitor remission, and detect potential relapse.

Data generated using clonoSEQ in its FDA-cleared indications and beyond will be featured in 9 oral presentations and 25 posters at ASH. The data to be presented demonstrate the utility of clonoSEQ for MRD-directed therapy, the value of sustained, deep MRD negativity, and the use of clonoSEQ to identify circulating tumor cells and circulating tumor DNA (ctDNA) in several lymphoma subtypes. The MRD-related data presented at ASH this year demonstrates how MRD-based decision-making is translating directly to improved patient care in blood cancers.

Earlier this month, Palmetto GBA’s Molecular Diagnostics Program (MolDX) finalized a local coverage determination (LCD) which supports Medicare coverage for clonoSEQ to detect and monitor MRD in patients with B-ALL, MM, and CLL. The LCD supports the potential expansion of coverage for additional clonoSEQ indications, providing a clear pathway for Non-Hodgkin Lymphoma (NHL) and other lymphoid cancers.

Key presentation details:

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 ALL using DNA from bone marrow samples. In August 2020, clonoSEQ received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL.

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 MRD assessment in other lymphoid cancers and sample types, as well as for determination of IGHV mutation status in CLL/SLL patients. 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 Adaptive Biotechnologies
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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ADAPTIVE MEDIA
Erica Schmitt
206-279-2423
media@adaptivebiotech.com

ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
Carrie Mendivil, Gilmartin Group
investors@adaptivebiotech.com