Adaptive Biotechnologies Receives Updated Medicare Coverage for its Minimal Residual Disease (MRD) Assay, clonoSEQ® for Blood Cancer Patients
- Local coverage determination (LCD) confirms access to the only FDA-cleared in vitro diagnostic to detect and monitor minimal residual disease (MRD) from bone marrow and blood sample types in certain blood cancers
- LCD supports the expansion of coverage for additional clonoSEQ indications, providing a clear pathway for Non-Hodgkin’s Lymphoma (NHL) and other lymphoid cancers
“We are pleased that MolDX finalized the LCD for next-generation sequencing (NGS) tests for MRD, solidifying patient access to the critical results that our clonoSEQ Assay provides across the continuum of care,” said
The final LCD is consistent with the draft posted by Medicare in September of 2020, which established coverage of MRD as a “series of assays” in a patient with cancer and outlined specific coverage criteria for MRD tests. The LCD states that MRD testing for cancer is a sensitive and specific way to measure relative amounts of cancer cells in the body and has demonstrated its ability to impact patient care. The LCD also mentions that MRD assessment with clonoSEQ in lymphoid cancers, including ALL, MM and CLL, is a well-established tool for physicians.
clonoSEQ is the first and only
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
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 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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National Cancer Institute. Cancer Stat Facts: Non-Hodgkin Lymphoma. Accessed November 11, 2021. Available at: https://seer.cancer.gov/statfacts/html/nhl.html.
Source: Adaptive Biotechnologies