Adaptive Biotechnologies Launches Assay Enhancements to Increase clonoSEQ® Sensitivity for Clinical MRD Detection in Diffuse Large B-Cell Lymphoma
Adaptive Biotechnologies (NASDAQ: ADPT) has launched an enhanced version of its clonoSEQ assay for measuring residual disease (MRD) in diffuse large B-cell lymphoma (DLBCL) using circulating tumor DNA. The upgraded assay delivers a 7-fold increase in sensitivity while maintaining high specificity to minimize false positives.
The enhanced version received approval from New York State's Clinical Lab Evaluation Program (CLEP) and is the only DLBCL MRD assay available for clinical use with Medicare coverage. Since securing Medicare coverage in July 2022, clonoSEQ has been used to test over 2,800 DLBCL patients and was utilized by more than 640 providers in 2024.
DLBCL, affecting over 18,000 new patients annually, is the most common form of non-Hodgkin lymphoma, representing one-third of NHL cases. With 30-40% of patients experiencing relapse, the enhanced MRD testing capabilities help doctors assess treatment response and detect early cancer recurrence signs.
Adaptive Biotechnologies (NASDAQ: ADPT) ha lanciato una versione migliorata del suo test clonoSEQ per misurare la malattia residua (MRD) nel linfoma diffuso a grandi cellule B (DLBCL) utilizzando il DNA tumorale circolante. Il test aggiornato offre un aumento della sensibilità di 7 volte mantenendo un'alta specificità per ridurre al minimo i falsi positivi.
La versione migliorata ha ricevuto l'approvazione dal Programma di Valutazione dei Laboratori Clinici dello Stato di New York (CLEP) ed è l'unico test MRD per DLBCL disponibile per uso clinico con copertura Medicare. Dalla sua approvazione per Medicare nel luglio 2022, clonoSEQ è stato utilizzato per testare oltre 2.800 pazienti con DLBCL ed è stato impiegato da più di 640 fornitori nel 2024.
Il DLBCL, che colpisce oltre 18.000 nuovi pazienti all'anno, è la forma più comune di linfoma non Hodgkin, rappresentando un terzo dei casi di NHL. Con il 30-40% dei pazienti che sperimentano una recidiva, le capacità migliorate di testare la MRD aiutano i medici a valutare la risposta al trattamento e a rilevare segni precoci di recidiva del cancro.
Adaptive Biotechnologies (NASDAQ: ADPT) ha lanzado una versión mejorada de su ensayo clonoSEQ para medir la enfermedad residual (MRD) en el linfoma difuso de células B grandes (DLBCL) utilizando ADN tumoral circulante. El ensayo mejorado ofrece un aumento de sensibilidad de 7 veces mientras mantiene una alta especificidad para minimizar los falsos positivos.
La versión mejorada recibió la aprobación del Programa de Evaluación de Laboratorios Clínicos del Estado de Nueva York (CLEP) y es el único ensayo de MRD para DLBCL disponible para uso clínico con cobertura de Medicare. Desde que obtuvo cobertura de Medicare en julio de 2022, clonoSEQ se ha utilizado para evaluar a más de 2,800 pacientes con DLBCL y fue utilizado por más de 640 proveedores en 2024.
El DLBCL, que afecta a más de 18,000 nuevos pacientes anualmente, es la forma más común de linfoma no Hodgkin, representando un tercio de los casos de NHL. Con un 30-40% de los pacientes experimentando recaídas, las capacidades mejoradas de prueba de MRD ayudan a los médicos a evaluar la respuesta al tratamiento y detectar signos tempranos de recidiva del cáncer.
Adaptive Biotechnologies (NASDAQ: ADPT)가 순환 종양 DNA를 사용하여 미만성 대세포 B 림프종(DLBCL)에서 잔여 질병(MRD)을 측정하기 위한 clonoSEQ 검사의 향상된 버전을 출시했습니다. 업그레이드된 검사는 감도 7배 증가를 제공하면서 높은 특이성을 유지하여 위양성을 최소화합니다.
향상된 버전은 뉴욕주 임상 실험실 평가 프로그램(CLEP)의 승인을 받았으며, Medicare 커버리지가 있는 임상 사용을 위한 유일한 DLBCL MRD 검사입니다. 2022년 7월 Medicare 커버리지를 확보한 이후, clonoSEQ는 2,800명 이상의 DLBCL 환자를 검사하는 데 사용되었으며, 2024년에는 640명 이상의 제공자가 이를 이용했습니다.
DLBCL은 매년 18,000명 이상의 신규 환자에게 영향을 미치며, 비호지킨 림프종의 가장 흔한 형태로 NHL 사례의 1/3을 차지합니다. 30-40%의 환자가 재발을 경험하므로 향상된 MRD 검사 능력은 의사가 치료 반응을 평가하고 초기 암 재발 징후를 감지하는 데 도움이 됩니다.
Adaptive Biotechnologies (NASDAQ: ADPT) a lancé une version améliorée de son test clonoSEQ pour mesurer la maladie résiduelle (MRD) dans le lymphome diffus à grandes cellules B (DLBCL) en utilisant l'ADN tumoral circulant. Le test mis à jour offre une augmentation de sensibilité de 7 fois tout en maintenant une haute spécificité pour minimiser les faux positifs.
La version améliorée a reçu l'approbation du Programme d'Évaluation des Laboratoires Cliniques de l'État de New York (CLEP) et est le seul test MRD pour DLBCL disponible pour une utilisation clinique avec couverture Medicare. Depuis l'obtention de la couverture Medicare en juillet 2022, clonoSEQ a été utilisé pour tester plus de 2 800 patients DLBCL et a été utilisé par plus de 640 fournisseurs en 2024.
Le DLBCL, qui affecte plus de 18 000 nouveaux patients chaque année, est la forme la plus courante de lymphome non-Hodgkin, représentant un tiers des cas de NHL. Avec 30 à 40 % des patients connaissant une rechute, les capacités améliorées de test MRD aident les médecins à évaluer la réponse au traitement et à détecter les signes précoces de récidive du cancer.
Adaptive Biotechnologies (NASDAQ: ADPT) hat eine verbesserte Version seines clonoSEQ-Assays zur Messung von Residualerkrankungen (MRD) bei diffus großzelligen B-Zell-Lymphomen (DLBCL) unter Verwendung von zirkulierender Tumor-DNA eingeführt. Der aktualisierte Test bietet eine 7-fache Erhöhung der Sensitivität, während eine hohe Spezifität beibehalten wird, um falsch positive Ergebnisse zu minimieren.
Die verbesserte Version erhielt die Genehmigung des Clinical Lab Evaluation Program (CLEP) des Bundesstaates New York und ist der einzige DLBCL-MRD-Test, der für die klinische Anwendung mit Medicare-Abdeckung verfügbar ist. Seit der Sicherstellung der Medicare-Abdeckung im Juli 2022 wurde clonoSEQ zur Untersuchung von über 2.800 DLBCL-Patienten verwendet und wurde von mehr als 640 Anbietern im Jahr 2024 genutzt.
DLBCL, das jährlich über 18.000 neue Patienten betrifft, ist die häufigste Form des Non-Hodgkin-Lymphoms und macht ein Drittel der NHL-Fälle aus. Da 30-40% der Patienten eine Rückfall erleben, helfen die verbesserten MRD-Testfähigkeiten den Ärzten, die Behandlungsergebnisse zu bewerten und frühe Anzeichen einer Krebserkrankung zu erkennen.
- 7-fold increase in assay sensitivity while maintaining specificity
- Only DLBCL MRD test available for clinical use with Medicare coverage
- Strong market penetration with 2,800+ patients tested and 640+ providers using the test in 2024
- Included in NCCN Clinical Practice Guidelines for B-Cell Lymphomas
- None.
Insights
Adaptive Biotechnologies' enhanced clonoSEQ assay represents a significant technological advancement in minimal residual disease (MRD) testing for DLBCL. The 7-fold increase in sensitivity while maintaining specificity addresses a critical clinical challenge in lymphoma management. This balance is particularly important as false positives would lead to unnecessary treatment intensification with potential toxicities, while false negatives could miss opportunities for early intervention.
The assay's approach of reading complete immune receptor sequences of malignant B-cells (rather than relying on individual point mutations) provides a fundamentally more robust detection method than alternative approaches. The New York State CLEP approval adds regulatory validation to these enhancements and aligns with the updated NCCN guidelines recommending ctDNA testing for MRD assessment in PET-positive DLBCL patients.
For context, DLBCL's 30-40% relapse rate creates an urgent need for better prognostic tools. The data presented at ASH 2024 showing MRD negativity post-cycle six as highly prognostic of progression-free survival confirms the test's clinical utility. As clinical trials increasingly explore MRD-directed treatment consolidation strategies, this enhanced assay positions Adaptive at the forefront of precision medicine in lymphoma care.
Adaptive's clonoSEQ enhancement strategically strengthens its market position in the growing field of MRD testing. As the only DLBCL MRD test available for clinical use with Medicare coverage, Adaptive has established a significant competitive moat in a substantial market - DLBCL affects approximately 18,000 new patients annually in the US alone.
The company has demonstrated meaningful market traction, with 2,800+ DLBCL patients tested and 640+ providers using the test in 2024. The enhanced sensitivity should drive further adoption among oncologists seeking more accurate prognostic information. The NCCN guideline update recommending ctDNA testing for MRD assessment serves as a powerful catalyst for clinical adoption.
The test's dual-use potential is particularly valuable - beyond direct clinical applications, it's being incorporated into both biopharma-sponsored and investigator-initiated trials. This creates multiple revenue streams and positions Adaptive to benefit from the growing trend toward MRD-guided treatment paradigms.
While the announcement doesn't specify pricing or new reimbursement developments, the existing Medicare coverage (secured July 2022) provides a stable revenue foundation. This product enhancement represents an incremental but meaningful improvement to Adaptive's diagnostic portfolio that should positively impact adoption rates and market share in the DLBCL testing space.
Enhanced assay granted approval by New York State’s Clinical Lab Evaluation Program (CLEP) for patients with DLBCL
clonoSEQ is the only DLBCL MRD assay available for clinical use and covered by Medicare
SEATTLE, March 11, 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 it has launched an upgraded version of its clonoSEQ assay for measurable residual disease (MRD) detection in diffuse large B-cell lymphoma (DLBCL) using circulating tumor DNA (ctDNA).
The enhanced clonoSEQ assay, which incorporates an optimized DNA extraction methodology and maximizes sample input, delivers a 7-fold increase in sensitivity. The assay leverages the same powerful technology as prior versions, detecting MRD by reading the full immune receptor sequence of the malignant B cells rather than relying on individual point mutations. Maintaining this proprietary approach enables improvements in sensitivity while preserving the exquisite specificity that minimizes risk of overtreatment due to false positives.
The enhanced assay was previously made available for research use in November 2023 and is already being incorporated into both biopharma-sponsored and investigator-initiated prospective trials. Data generated using this assay and presented at ASH 2024 by Bond and colleagues demonstrated that in patients for which MRD was assessed by clonoSEQ, MRD negativity post-cycle six was highly prognostic of progression-free survival.
“The enhancements to our clonoSEQ ctDNA-based DLBCL test offering strengthen the assay’s already-deep clinical sensitivity without compromising our unparalleled specificity,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “The assay’s strong performance on both fronts makes it possible to deliver accurate, actionable insights in the clinic and empowers drug developers to precisely target treatment intensification strategies for patients who remain MRD-positive at end of frontline therapy while minimizing the risk of overtreatment.”
clonoSEQ is the first and only DLBCL MRD test available for clinical use. Having secured Medicare coverage for clonoSEQ in DLBCL in July of 2022, Adaptive has since provided MRD testing for more than 2,800 DLBCL patients and was used to manage and inform patient care by over 640 providers in 2024 alone. The New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) recently approved the enhanced version of the clonoSEQ ctDNA assay for the detection and monitoring of MRD in patients with DLBCL. This comes on the heels of the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas, which included language recommending ctDNA testing for MRD assessment for patients with PET-positive DLBCL at end of first-line treatment.
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about 1 out of every 3 NHL patients in the United States. More than 18,000 people are diagnosed with DLBCL each year. About 30–
Because DLBCL outcomes can vary widely following frontline treatment, the ability of MRD results to accurately risk stratify patients in this setting is critical, as an MRD test can help clinicians differentiate a likely cure from an impending relapse. As the number of clinical trials in DLBCL exploring novel MRD-directed treatment consolidation strategies to reduce relapse rates grows, the role for clonoSEQ as a highly sensitive and specific ctDNA-based test will continue to expand.
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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FAQ
What improvements does the enhanced clonoSEQ assay offer for DLBCL patients?
How many DLBCL patients has ADPT's clonoSEQ tested since receiving Medicare coverage?
What is the relapse rate for DLBCL patients and why is MRD testing important?
What regulatory approvals has ADPT's enhanced clonoSEQ assay received?
