Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Assessing Measurable Residual Disease in Mantle Cell Lymphoma
Adaptive Biotechnologies (NASDAQ: ADPT) announced expanded Medicare coverage for its clonoSEQ test to include measurable residual disease (MRD) assessment in mantle cell lymphoma (MCL) patients. The coverage follows Medicare's episode pricing structure with an updated rate of $8,029. MCL, affecting approximately 4,000 new cases annually in the US, is an aggressive form of non-Hodgkin lymphoma where most patients experience multiple relapses. clonoSEQ offers a minimally invasive, blood-based MRD testing option to assess treatment response and monitor disease progression. This expansion adds to existing Medicare coverage for multiple myeloma, chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia, and diffuse large B-cell lymphoma.
Adaptive Biotechnologies (NASDAQ: ADPT) ha annunciato un'estensione della copertura Medicare per il suo test clonoSEQ, che include la valutazione della malattia residua misurabile (MRD) nei pazienti affetti da linfoma a cellule mantellari (MCL). La copertura segue la struttura di pricing per episodio di Medicare con una tariffa aggiornata di $8.029. MCL, che colpisce circa 4.000 nuovi casi annui negli Stati Uniti, è una forma aggressiva di linfoma non-Hodgkin in cui la maggior parte dei pazienti presenta molteplici recidive. clonoSEQ offre un'opzione di test MRD minimamente invasiva, basata su un prelievo di sangue, per valutare la risposta al trattamento e monitorare la progressione della malattia. Questa espansione si aggiunge alla copertura Medicare esistente per il mieloma multiplo, la leucemia linfatica cronica, la leucemia linfoblastica acuta a cellule B e il linfoma diffuso a grandi cellule B.
Adaptive Biotechnologies (NASDAQ: ADPT) anunció una expansión de la cobertura de Medicare para su prueba clonoSEQ que incluye la evaluación de la enfermedad residual medible (MRD) en pacientes con linfoma de células de manto (MCL). La cobertura sigue la estructura de precios por episodio de Medicare con una tarifa actualizada de $8,029. MCL, que afecta aproximadamente a 4,000 nuevos casos anuales en los EE. UU., es una forma agresiva de linfoma no Hodgkin en la que la mayoría de los pacientes experimentan múltiples recaídas. clonoSEQ ofrece una opción de prueba de MRD mínimamente invasiva, basada en análisis de sangre, para evaluar la respuesta al tratamiento y monitorear la progresión de la enfermedad. Esta expansión se suma a la cobertura existente de Medicare para mieloma múltiple, leucemia linfocítica crónica, leucemia linfoblástica aguda de células B y linfoma difuso de células B grandes.
Adaptive Biotechnologies (NASDAQ: ADPT)는 clonoSEQ 검사가 맨틀 세포 림프종(MCL) 환자의 측정 가능한 잔여 질병(MRD) 평가를 포함하도록 Medicare의 보장이 확대되었다고 발표했습니다. 이 보장은 Medicare의 에피소드 가격 구조를 따르며 업데이트된 요금은 $8,029입니다. MCL은 미국에서 매년 약 4,000건의 새로운 사례에 영향을 미치는 비호지킨 림프종의 공격적인 형태로, 대부분의 환자가 다수의 재발을 경험합니다. clonoSEQ는 치료 반응을 평가하고 질병 진행을 모니터링하기 위한 최소 침습적 혈액 기반 MRD 검사 옵션을 제공합니다. 이번 확장은 다발성 골수종, 만성 림프구성 백혈병, B세포 급성 림프모구 백혈병 및 미만성 대세포 B림프종에 대한 기존 Medicare 보장에 추가됩니다.
Adaptive Biotechnologies (NASDAQ: ADPT) a annoncé une couverture Medicare élargie pour son test clonoSEQ, qui inclut l'évaluation de la maladie résiduelle mesurable (MRD) chez les patients atteints de lymphome à cellules mantiques (MCL). Cette couverture suit la structure de prix des épisodes de Medicare avec un tarif mis à jour de 8 029 $. MCL, qui touche environ 4 000 nouveaux cas chaque année aux États-Unis, est une forme agressive de lymphome non hodgkinien où la plupart des patients connaissent de multiples rechutes. clonoSEQ offre une option de test MRD peu invasive, basée sur un prélèvement sanguin, pour évaluer la réponse au traitement et surveiller la progression de la maladie. Cette expansion s'ajoute à la couverture Medicare existante pour le myélome multiple, la leucémie lymphocytaire chronique, la leucémie lymphoblastique aiguë à cellules B et le lymphome diffus à grandes cellules B.
Adaptive Biotechnologies (NASDAQ: ADPT) gab eine erweiterte Medicare-Abdeckung für seinen clonoSEQ-Test bekannt, die die Bewertung der messbaren Resterkrankung (MRD) bei Patienten mit Mantelzelllymphom (MCL) umfasst. Die Abdeckung folgt der Preisstruktur für episodische Pflege von Medicare mit einem aktualisierten Satz von 8.029 $. MCL, das jährlich etwa 4.000 neue Fälle in den USA betrifft, ist eine aggressive Form des Non-Hodgkin-Lymphoms, bei der die meisten Patienten multiple Rückfälle erleben. clonoSEQ bietet eine minimal invasive, blutbasierte MRD-Testmöglichkeit zur Bewertung der Behandlungsreaktion und zur Überwachung des Krankheitsverlaufs. Diese Erweiterung ergänzt die bestehende Medicare-Abdeckung für multiples Myelom, chronische lymphatische Leukämie, akute lymphoblastische Leukämie vom B-Zell-Typ und diffuses großzelluläres B-Zell-Lymphom.
- Medicare coverage expansion to include MCL indication
- Updated Medicare pricing established at $8,029 per episode
- Addresses a market of approximately 4,000 new MCL cases annually in the US
- Coverage applies to all MCL patients regardless of therapy line or treatment
- None.
Insights
The expanded Medicare coverage for clonoSEQ in MCL testing represents a significant market opportunity. With
The clinical utility is well-established - MCL's aggressive nature and variable relapse patterns make regular monitoring crucial. Blood-based MRD testing offers a less invasive alternative to traditional monitoring methods, potentially increasing testing frequency and recurring revenue. The recent gapfill rate alignment also provides clarity on reimbursement economics across all covered indications.
This coverage decision strengthens Adaptive's market position in blood cancer diagnostics. clonoSEQ is now covered for five major blood cancer indications under Medicare, creating a comprehensive testing portfolio. The
The recurring nature of MCL monitoring, combined with the disease's long-term management needs (up to 15 years post-remission), suggests strong potential for sustained revenue growth. This expansion particularly benefits ADPT as it targets a predominantly Medicare-age population, reducing reimbursement uncertainty.
clonoSEQ is the first and only assay to receive Medicare coverage for MRD assessment in MCL
Coverage leverages new Medicare episode pricing established based on updated clonoSEQ gapfill rate
SEATTLE, Nov. 07, 2024 (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 Diagnostics Services Program (MolDX), has expanded coverage of clonoSEQ® to include detection and monitoring of measurable residual disease (MRD) in Medicare patients with mantle cell lymphoma (MCL).
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 It is an aggressive disease, and most patients will relapse repeatedly; some shortly after frontline therapy, while others as late as 15 years after initial remission.2,3 Given this challenging and variable course of disease, it is critical to effectively assess depth of response in patients undergoing treatment and monitor for recurrence or disease progression following remission.
MRD, or the cancer cells that may remain in a patient’s body during and after treatment, is assessed through a series of tests over a patient’s cancer journey. In MCL, clonoSEQ is a minimally invasive, blood-based MRD testing option that can be used to assess response, understand prognosis, and monitor patients to detect molecular recurrence before clinical or radiographic relapse.
“The value of MRD in MCL has been demonstrated in studies and supported by experiences in our own clinical practice,” said Anita Kumar, M.D., associate attending physician, Memorial Sloan Kettering Cancer Center. “New treatment strategies in MCL are improving the outlook for patients with this aggressive disease, creating a need for MRD insights as a complement to traditional MCL monitoring tools such as imaging. Access to highly sensitive, blood-based MRD testing will empower clinicians to more precisely monitor the quality and depth of response and remission, and more accurately predict clinical relapse.”
This updated coverage policy significantly expands access to clonoSEQ MRD testing for patients being treated for MCL, as the majority are of Medicare age. The policy extends to all patients with MCL, regardless of line of therapy or treatment regimen. The MolDX coverage follows the existing Medicare episode payment structure utilized for all other covered clonoSEQ indications. Following the Clinical Laboratory Fee Schedule (CLFS) annual payment determination process, MolDX recently updated clonoSEQ episode pricing across all the currently covered indications to
“In an incurable disease such as MCL, implementing clonoSEQ MRD assessment is essential not only to identify those patients at high risk of relapse but also for advancing patient-centric treatment interventions and multi-modal monitoring strategies,” said Ben Eckert, senior vice president, Market Access, Adaptive Biotechnologies. “We’re pleased with MolDX’s decision to provide access to clonoSEQ for the MCL Medicare population, as coverage will enable further integration of this important tool into lymphoma care pathways and ultimately improve outcomes for patients.”
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 MEDIA:
Erica Jones, Associate Director, Corporate Communications
206-279-2423
media@adaptivebiotech.com
ADAPTIVE INVESTORS:
Karina Calzadilla, Vice President, Investor Relations
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investors@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.
2 Cohen JB, Ruppert AS, Heerema NA, et al. Complex karyotype is associated with aggressive disease and shortened progression-free survival in patients with newly diagnosed mantle cell lymphoma. Clin Lymphoma Myeloma Leuk. 2015;15(5):278-285.
3 Cheah CY, Seymour JF, Wang ML. Mantle cell lymphoma. J Clin Oncol. 2016;34(11):1256-1269.
FAQ
What is the new Medicare coverage rate for Adaptive Biotechnologies' (ADPT) clonoSEQ test?
What new indication did Medicare approve for Adaptive Biotechnologies' (ADPT) clonoSEQ test in November 2024?
How many MCL cases does Adaptive Biotechnologies' (ADPT) new coverage approval address annually?
