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
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.
Adaptive Biotechnologies (ADPT) ha annunciato che il suo test clonoSEQ® per la valutazione della malattia residua minima (MRD) ha ricevuto una nuova tariffa del Medicare Clinical Laboratory Fee Schedule (CLFS) di $2,007, a partire dal 1 gennaio 2025. Inoltre, MolDX ha aggiornato il prezzo dell'episodio clonoSEQ a $8,029 per tutte le indicazioni coperte.
La tariffa CLFS è stata stabilita attraverso un processo di determinazione di gapfill, in cui Medicare valuta il valore del test sulla base di fattori come le risorse necessarie, le tariffe di altri pagatori e i costi di tecnologie simili. Il test clonoSEQ fornisce misure di MRD nelle neoplasie linfatiche ed è ampiamente coperto da Medicare e da pagatori commerciali.
Con questa tariffa definitiva, Adaptive prevede di utilizzarla per stabilire nuovi accordi con i pagatori, aggiornare gli accordi esistenti per includere il codice PLA clonoSEQ e ampliare la copertura a ulteriori indicazioni.
Adaptive Biotechnologies (ADPT) anunció que su prueba clonoSEQ® para la evaluación de la enfermedad residual mínima (MRD) ha recibido una nueva tarifa del Medicare Clinical Laboratory Fee Schedule (CLFS) de $2,007, efectiva a partir del 1 de enero de 2025. Además, MolDX ha actualizado el precio del episodio de clonoSEQ a $8,029 para todas las indicaciones cubiertas.
La tarifa CLFS se estableció a través de un proceso de determinación de gapfill, donde Medicare evalúa el valor de la prueba en función de factores como los recursos necesarios, las tarifas de otros pagadores y los costos de tecnologías similares. La prueba clonoSEQ proporciona mediciones de MRD en malignidades linfáticas y está ampliamente cubierta por Medicare y pagadores comerciales.
Con esta tarifa finalizada, Adaptive planea aprovecharla para establecer nuevos acuerdos con pagadores, actualizar acuerdos existentes para incluir el código PLA clonoSEQ y expandir la cobertura a indicaciones adicionales.
Adaptive Biotechnologies (ADPT)는 최소 잔여 질병(MRD) 평가를 위한 clonoSEQ® 테스트가 2025년 1월 1일부터 시행되는 $2,007의 새로운 Medicare Clinical Laboratory Fee Schedule (CLFS) 요금을 받았다고 발표했습니다. 또한, MolDX는 모든 보장 항목에 대해 clonoSEQ 에피소드 가격을 $8,029로 업데이트했습니다.
CLFS 요금은 Medicare가 필요한 자원, 다른 지불자 요금, 유사 기술 비용 등을 포함한 요인을 바탕으로 테스트의 가치를 평가하는 gapfill 결정 프로세스를 통해 설정되었습니다. clonoSEQ 테스트는 림프조직 악성 종양에서 MRD 측정을 제공하며, Medicare 및 상업적 지불자에 의해 널리 보장됩니다.
이 최종 요금을 통해 Adaptive는 새로운 지불자 계약을 체결하고, clonoSEQ PLA 코드를 포함하도록 기존 계약을 업데이트하며, 추가 지표에 대한 보장을 확장할 계획입니다.
Adaptive Biotechnologies (ADPT) a annoncé que son test clonoSEQ® pour l'évaluation de la maladie résiduelle minimale (MRD) a reçu un nouveau tarif de $2,007 dans le Medicare Clinical Laboratory Fee Schedule (CLFS), applicable à partir du 1er janvier 2025. De plus, MolDX a mis à jour le prix de l'épisode clonoSEQ à $8,029 pour toutes les indications couvertes.
Le tarif CLFS a été établi par un processus de détermination de gapfill, où Medicare évalue la valeur du test en se basant sur des facteurs tels que les ressources nécessaires, les tarifs d'autres payeurs et le coût de technologies similaires. Le test clonoSEQ fournit des mesures de MRD dans les malignités lymphoïdes et est largement couvert par Medicare et des payeurs commerciaux.
Avec ce tarif finalisé, Adaptive prévoit de l'utiliser pour établir de nouveaux accords avec les payeurs, mettre à jour les accords existants pour inclure le code PLA clonoSEQ et élargir la couverture à d'autres indications.
Adaptive Biotechnologies (ADPT) hat angekündigt, dass sein clonoSEQ®-Test zur Bewertung der minimalen Resterkrankung (MRD) einen neuen Tarif von $2,007 im Medicare Clinical Laboratory Fee Schedule (CLFS) erhalten hat, der ab dem 1. Januar 2025 gültig ist. Darüber hinaus hat MolDX die Episodenpreise für clonoSEQ auf $8,029 für alle abgedeckten Indikationen aktualisiert.
Die CLFS-Tarif wurde durch einen Gapfill-Bestimmungsprozess festgelegt, bei dem Medicare den Wert des Tests anhand von Faktoren wie benötigten Ressourcen, Tarifen anderer Zahler und Kosten ähnlicher Technologien bewertet. Der clonoSEQ-Test bietet MRD-Messungen bei lymphatischen malignen Erkrankungen und wird von Medicare sowie gewerblichen Zahlern umfassend abgedeckt.
Mit diesem endgültigen Tarif plant Adaptive, ihn zur Establishierung neuer Zahlungsverträge zu nutzen, bestehende Vereinbarungen zu aktualisieren, um den clonoSEQ-PLA-Code einzuschließen, und die Abdeckung auf weitere Indikationen auszuweiten.
- 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
- 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
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.
In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.
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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?
