Adaptive Biotechnologies Announces Clinical Lab Fee Schedule Rate of $2,007 for clonoSEQ® Test for Minimal Residual Disease Assessment is Effective as of January 1st, 2025
SEATTLE, Jan. 07, 2025 (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, announced today that the new Medicare Clinical Laboratory Fee Schedule (CLFS) rate for its next-generation sequencing (NGS)-based clonoSEQ® test for minimal – or measurable – residual disease (MRD) assessment is now in effect as of January 1, 2025. The CLFS rate for clonoSEQ (PLA 0364U) was set at $2,007, consistent with the final gapfill rate recommendation for the test.
The CLFS, managed by the Centers for Medicare & Medicaid Services (CMS), establishes payment rates for lab tests covered by Medicare. Novel diagnostic laboratory tests like clonoSEQ, for which there is no existing comparable test, undergo a special pricing process known as gapfill determination. In this process, Medicare assesses the test’s value by considering factors such as the resources required to perform the test, rates paid for the test by other payers, rates paid for tests leveraging similar technologies, and additional unique attributes of the test. After a year of evaluation, CMS finalizes a national rate to ensure that essential tests like clonoSEQ are fairly priced and accessible to patients who need them. Many other payers in the US look to the Medicare CLFS in establishing their rate schedules for diagnostic tests that they cover.
As previously announced, MolDX has also updated clonoSEQ episode pricing to $8,029, in line with this new CLFS rate across all covered indications, including multiple myeloma, chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia, circulating tumor DNA-based MRD testing in diffuse large B-cell lymphoma and mantle cell lymphoma.
“Finalizing the Medicare reimbursement rate for clonoSEQ through the gapfill process represents another key milestone and highlights the value of the test in patient care,” said Ben Eckert, senior vice president, Market Access, Adaptive Biotechnologies. “MRD testing provides clinicians with essential insights into a patient’s disease status and response to therapy. With the newly defined rate, we look forward to driving broader adoption by healthcare providers and private insurers, expanding accessibility for patients living with blood cancers."
The clonoSEQ test provides accurate and sensitive measurement of MRD in lymphoid malignancies and is widely covered by both Medicare and commercial payers for patients with lymphoid cancers. With the completion of the CLFS pricing process for clonoSEQ, Adaptive plans to leverage the finalized rate in the process of establishing new payer agreements, updating existing agreements to include the clonoSEQ PLA code, and expanding coverage to additional indications.
About clonoSEQ
clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA.
clonoSEQ leverages Adaptive Biotechnologies’ 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 treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. 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 clonoSEQ in patients diagnosed with CLL, MM, ALL, DLBCL and MCL.
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 (“we” or “our”) 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. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.
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