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
Rhea-AI Summary
Adaptive Biotechnologies (ADPT) announced that its clonoSEQ® test for minimal residual disease (MRD) assessment has received a new Medicare Clinical Laboratory Fee Schedule (CLFS) rate of $2,007, effective January 1, 2025. Additionally, MolDX has updated the clonoSEQ episode pricing to $8,029 across all covered indications.
The CLFS rate was established through a gapfill determination process, where Medicare evaluates the test's value based on factors including required resources, other payer rates, and similar technology costs. The clonoSEQ test provides MRD measurement in lymphoid malignancies and is widely covered by Medicare and commercial payers.
With this finalized rate, Adaptive plans to leverage it for establishing new payer agreements, updating existing agreements to include the clonoSEQ PLA code, and expanding coverage to additional indications.
Positive
- Medicare sets favorable reimbursement rate of $2,007 for clonoSEQ test
- MolDX updates episode pricing to $8,029 across all covered indications
- Wide coverage by both Medicare and commercial payers
- Potential for expanded coverage and new payer agreements
Negative
- None.
Insights
The
The gapfill determination process outcome signals strong value recognition from CMS, which typically influences private payer decisions. This established benchmark will likely accelerate commercial payer adoption and contract negotiations, potentially expanding Adaptive's billable test volume and revenue streams. The comprehensive coverage across multiple blood cancer indications provides multiple growth vectors.
For context, diagnostic test reimbursement rates significantly impact adoption patterns and company economics. The finalized rate structure supports sustainable margins while keeping the test accessible - a critical balance for market penetration. This pricing framework could drive increased test utilization, particularly in community oncology settings where reimbursement clarity is essential for adoption.
The clonoSEQ test's reimbursement milestone carries strategic importance in the growing MRD testing market. The test's ability to provide sensitive MRD measurement across multiple lymphoid malignancies, combined with established Medicare coverage and expanding commercial coverage, creates a compelling market position.
The expanded indication coverage including multiple myeloma, CLL, B-ALL, DLBCL and mantle cell lymphoma represents a comprehensive approach to blood cancer monitoring. Think of MRD testing as a high-precision tool that helps oncologists make more informed treatment decisions - similar to having a highly sensitive GPS for tracking cancer cells. This broad coverage scope, supported by the new pricing structure, should accelerate clinical adoption patterns.
The timing is particularly relevant as personalized medicine and precision monitoring gain prominence in oncology care protocols. Healthcare providers increasingly rely on MRD testing to optimize treatment strategies and monitor patient responses, making favorable reimbursement important for widespread implementation.
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
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
“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.
Forward Looking Statements
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ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
investors@adaptivebiotech.com
ADAPTIVE MEDIA
Erica Jones, Associate Corporate Communications Director
206-279-2423
media@adaptivebiotech.com
FAQ
What is the new Medicare reimbursement rate for ADPT's clonoSEQ test in 2025?
What is the MolDX episode pricing for ADPT's clonoSEQ test in 2025?
What conditions are covered under ADPT's clonoSEQ test Medicare reimbursement?
How was the new CLFS rate for ADPT's clonoSEQ determined?
What are ADPT's plans following the Medicare CLFS rate finalization?
