Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Surveillance in Mantle Cell Lymphoma
Adaptive Biotechnologies (Nasdaq: ADPT) has secured expanded Medicare coverage for its clonoSEQ® test in mantle cell lymphoma (MCL) surveillance. The coverage now includes single time point testing to monitor disease recurrence in patients during treatment-free remission.
Under the expanded coverage by Palmetto GBA, patients who have completed treatment can receive clonoSEQ testing every six months for up to five years during treatment-free remission, followed by annual testing until disease recurrence. The test pricing is set at $2,007 per test under the Clinical Laboratory Fee Schedule.
MCL, affecting approximately 4,000 new cases annually in the United States, is the first clonoSEQ indication to receive this coverage determination. The test is performed at Adaptive's CLIA-certified lab in Seattle and has received approval from New York State's Clinical Laboratory Evaluation Program.
Adaptive Biotechnologies (Nasdaq: ADPT) ha ottenuto un'estensione della copertura Medicare per il suo test clonoSEQ® nella sorveglianza del linfoma a cellule mantellari (MCL). La copertura ora include il test a un solo punto temporale per monitorare la ricorrenza della malattia nei pazienti durante la remissione senza trattamento.
Sotto la copertura ampliata da Palmetto GBA, i pazienti che hanno completato il trattamento possono ricevere il test clonoSEQ ogni sei mesi per un massimo di cinque anni durante la remissione senza trattamento, seguito da test annuali fino alla ricorrenza della malattia. Il prezzo del test è fissato a $2,007 per test secondo il Clinical Laboratory Fee Schedule.
Il MCL, che colpisce circa 4.000 nuovi casi all'anno negli Stati Uniti, è la prima indicazione per clonoSEQ a ricevere questa determinazione di copertura. Il test viene eseguito presso il laboratorio certificato CLIA di Adaptive a Seattle e ha ricevuto l'approvazione dal Programma di Valutazione dei Laboratori Clinici dello Stato di New York.
Adaptive Biotechnologies (Nasdaq: ADPT) ha asegurado una cobertura ampliada de Medicare para su prueba clonoSEQ® en la vigilancia del linfoma de células del manto (MCL). La cobertura ahora incluye pruebas de un solo punto temporal para monitorear la recurrencia de la enfermedad en pacientes durante la remisión sin tratamiento.
Bajo la cobertura ampliada por Palmetto GBA, los pacientes que han completado el tratamiento pueden recibir pruebas de clonoSEQ cada seis meses durante un máximo de cinco años durante la remisión sin tratamiento, seguidas de pruebas anuales hasta la recurrencia de la enfermedad. El precio de la prueba se establece en $2,007 por prueba según el Clinical Laboratory Fee Schedule.
El MCL, que afecta aproximadamente a 4,000 nuevos casos anuales en los Estados Unidos, es la primera indicación de clonoSEQ en recibir esta determinación de cobertura. La prueba se realiza en el laboratorio certificado por CLIA de Adaptive en Seattle y ha recibido la aprobación del Programa de Evaluación de Laboratorios Clínicos del Estado de Nueva York.
Adaptive Biotechnologies (Nasdaq: ADPT)는 clonoSEQ® 검사의 확장된 Medicare 보장을 확보했습니다. 이 검사는 맨틀 세포 림프종(MCL) 감시를 위한 것으로, 이제 치료 없이 관해 중인 환자에서 질병 재발을 모니터링하기 위해 단일 시점 테스트를 포함합니다.
Palmetto GBA에 의해 확대된 보장에 따라, 치료를 완료한 환자는 치료 없이 관해 중 최대 5년 동안 6개월마다 clonoSEQ 검사를 받을 수 있으며, 이후 질병 재발 시까지 연간 검사가 진행됩니다. 검사의 가격은 Clinical Laboratory Fee Schedule에 따라 $2,007로 설정되어 있습니다.
MCL은 미국에서 매년 약 4,000건의 새로운 사례에 영향을 미치며, clonoSEQ가 이 보장 결정을 받은 첫 번째 적응증입니다. 이 검사는 시애틀에 있는 Adaptive의 CLIA 인증 실험실에서 수행되며, 뉴욕주 임상 실험실 평가 프로그램의 승인을 받았습니다.
Adaptive Biotechnologies (Nasdaq: ADPT) a obtenu une couverture Medicare élargie pour son test clonoSEQ® dans la surveillance du lymphome à cellules du manteau (MCL). La couverture inclut désormais des tests à un point temporel unique pour surveiller la récidive de la maladie chez les patients en rémission sans traitement.
Dans le cadre de la couverture élargie par Palmetto GBA, les patients ayant terminé leur traitement peuvent recevoir un test clonoSEQ tous les six mois pendant une période maximale de cinq ans en rémission sans traitement, suivi de tests annuels jusqu'à la récidive de la maladie. Le prix du test est fixé à $2,007 par test selon le Clinical Laboratory Fee Schedule.
Le MCL, qui touche environ 4 000 nouveaux cas par an aux États-Unis, est la première indication de clonoSEQ à recevoir cette décision de couverture. Le test est effectué dans le laboratoire certifié CLIA d'Adaptive à Seattle et a reçu l'approbation du Programme d'Évaluation des Laboratoires Cliniques de l'État de New York.
Adaptive Biotechnologies (Nasdaq: ADPT) hat eine erweiterte Medicare-Abdeckung für seinen clonoSEQ® Test zur Überwachung von Mantelzelllymphom (MCL) gesichert. Die Abdeckung umfasst nun auch Tests zu einem einzigen Zeitpunk, um das Wiederauftreten der Krankheit bei Patienten während der behandlungsfreien Remission zu überwachen.
Unter der erweiterten Abdeckung durch Palmetto GBA können Patienten, die ihre Behandlung abgeschlossen haben, alle sechs Monate bis zu fünf Jahre lang clonoSEQ-Tests während der behandlungsfreien Remission erhalten, gefolgt von jährlichen Tests bis zum Wiederauftreten der Krankheit. Der Preis für den Test beträgt $2,007 pro Test gemäß dem Clinical Laboratory Fee Schedule.
MCL, das jährlich etwa 4.000 neue Fälle in den Vereinigten Staaten betrifft, ist die erste Indikation für clonoSEQ, die diese Deckungsentscheidung erhalten hat. Der Test wird im CLIA-zertifizierten Labor von Adaptive in Seattle durchgeführt und hat die Genehmigung des Clinical Laboratory Evaluation Program des Bundesstaates New York erhalten.
- Secured expanded Medicare coverage for clonoSEQ testing in MCL surveillance
- Coverage includes regular testing for up to 5 years post-treatment
- Established pricing of $2,007 per test under Medicare
- Test is already approved by NY State's Clinical Laboratory Evaluation Program
- None.
Insights
The expanded Medicare coverage for Adaptive's clonoSEQ test in mantle cell lymphoma (MCL) surveillance represents a significant revenue opportunity and reimbursement milestone. Under this coverage determination, MCL patients in remission will receive covered testing every six months for five years, then annually until recurrence is detected—substantially expanding the utilization window beyond active treatment.
At the established
Most critically, this coverage determination establishes a precedent that could be applied to other clonoSEQ indications. The company's statement that this "establishes a framework for potential expanded coverage" in other indications suggests this could be the first of multiple similar coverage expansions, which would multiply the financial impact.
The clinical value proposition is compelling: MCL patients frequently relapse even years after achieving remission, creating genuine clinical necessity for ongoing surveillance with sensitive testing methods. This alignment of clinical utility with favorable reimbursement positions clonoSEQ favorably in the precision oncology diagnostic market.
This Medicare coverage expansion for clonoSEQ in MCL surveillance addresses a critical clinical need in lymphoma management. MCL represents a particularly challenging malignancy with late relapses occurring up to 15 years after initial remission, making long-term surveillance essential but previously difficult to justify without coverage.
The ability to detect molecular recurrence through blood-based MRD testing offers significant advantages over traditional surveillance methods. clonoSEQ can detect disease re-emergence at much lower levels than imaging, allowing for earlier intervention when disease burden is minimal. The coverage structure—biannual testing for five years followed by annual testing—aligns with typical recurrence patterns in MCL.
What's particularly valuable is how this approach may "limit or guide imaging" in post-treatment surveillance. Rather than subjecting patients to frequent CT scans with associated radiation exposure, clinicians can potentially reserve imaging for when molecular recurrence is detected, creating a more rational, evidence-based surveillance paradigm.
This coverage decision validates the growing recognition that MRD assessment represents a paradigm shift in lymphoma management, moving from morphologic to molecular disease monitoring. For MCL patients specifically, who live with the psychological burden of knowing recurrence is likely, regular blood-based monitoring may provide both clinical utility and psychological reassurance.
clonoSEQ is now covered to monitor for recurrence in MCL patients who are in treatment-free remission
SEATTLE, April 08, 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, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its Molecular Diagnostic Services Program (MolDX), has expanded coverage of clonoSEQ® to include single time point testing to monitor for recurrence in patients with a history of mantle cell lymphoma (MCL).
This expanded coverage is in addition to the existing Medicare episode payment structure for clonoSEQ, which provides coverage for a bundle of tests to assess response to therapy while a patient is being treated. Under the expanded coverage decision, patients who have completed treatment are now covered to receive clonoSEQ testing every six months for up to five years during treatment-free remission and annual testing thereafter until disease recurrence is detected. MCL is the first clonoSEQ indication to receive this determination and pricing will be consistent with the recently updated Clinical Laboratory Fee Schedule (CLFS) rate of
“Securing coverage for clonoSEQ use in the MCL surveillance setting is a significant win for MCL patients. This coverage expansion enables clinicians to more effectively monitor and manage these patients who are at risk of relapse,” said Ben Eckert, senior vice president, Market Access, Adaptive Biotechnologies. “We believe this determination underscores the clinical utility of clonoSEQ testing and establishes a framework for potential expanded coverage of surveillance testing in other Medicare-covered clonoSEQ indications.”
MCL is a sub-type of non-Hodgkin lymphoma (NHL) with an annual incidence of approximately 4,000 cases per year in the United States.1 MRD is assessed through a series of tests over an MCL patient’s cancer journey and leverages blood to assess response, understand prognosis, and monitor patients to detect molecular recurrence. With modern treatment regimens, most patients will achieve disease remission after completion of front-line therapy and maintenance. However, due to the nature of MCL, many patients eventually relapse, some as late as 15 years after initial remission. Therefore, ongoing recurrence monitoring is particularly important in MCL, and clonoSEQ MRD testing in blood provides longitudinal insights that can be used to limit or guide imaging in this setting.
clonoSEQ testing for patients with MCL is currently available for clinical use as a laboratory-developed test performed at Adaptive's CLIA-certified lab in Seattle. clonoSEQ testing in MCL has also been previously approved by New York State's Clinical Laboratory Evaluation Program (CLEP).
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 patients with diffuse large B-cell lymphoma (DLBCL) is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle. clonoSEQ is CE-marked under the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU). For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request.
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 hematologic 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, B-ALL and DLBCL.
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 segments: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer and autoimmune disorders. 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.
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ADAPTIVE INVESTORS:
Karina Calzadilla, Vice President, Investor Relations and FP&A
201-396-1687
investors@adaptivebiotech.com
ADAPTIVE MEDIA:
Erica Jones, Associate Director, Corporate Communications
845-344-7542
media@adaptivebiotech.com
1 Kallam A, Vose J. Current treatments in mantle cell lymphoma. Oncology. 2023;37:326-333. https://www.cancernetwork.com/view/current-treatments-in-mantle-cell-lymphoma. Accessed November 5, 2024.
FAQ
What is the new Medicare coverage expansion for Adaptive Biotechnologies' clonoSEQ test (ADPT)?
How much does the clonoSEQ test cost under the new Medicare coverage?
How frequently can MCL patients receive covered clonoSEQ testing under the new Medicare policy?
What is the market size for mantle cell lymphoma that clonoSEQ can address?
Where is the clonoSEQ test for MCL patients currently performed?
