NeoGenomics’ Newly Published Study Underscores Potential of ctDNA as a Predictive Tool for Monitoring Patients with High-Risk Melanoma
NeoGenomics (NASDAQ: NEO) published a study in ESMO Open demonstrating the effectiveness of circulating tumor DNA (ctDNA) in monitoring molecular residual disease (MRD) for high-risk melanoma patients. The research, conducted with Princess Margaret Hospital, analyzed 276 plasma samples from 66 melanoma patients using NeoGenomics' RaDaR® sequencing assay.
The study revealed that ctDNA detection post-surgery can identify patients with worse prognosis and enable earlier detection of disease recurrence. Notably, the research successfully identified ctDNA in patients lacking BRAF and NRAS mutations, suggesting broader applicability compared to earlier studies. The findings have led to the development of the CLEAR-Me trial for detecting and clearing MRD in high-risk melanoma patients.
NeoGenomics (NASDAQ: NEO) ha pubblicato uno studio in ESMO Open che dimostra l'efficacia del DNA tumorale circolante (ctDNA) nel monitoraggio della malattia residua molecolare (MRD) per i pazienti con melanoma ad alto rischio. La ricerca, condotta con l'Ospedale Princess Margaret, ha analizzato 276 campioni di plasma provenienti da 66 pazienti con melanoma utilizzando l'assay di sequenziamento RaDaR® di NeoGenomics.
Lo studio ha rivelato che la rilevazione del ctDNA dopo l'intervento chirurgico può identificare i pazienti con prognosi peggiore e consentire una diagnosi precoce della recidiva della malattia. In particolare, la ricerca ha identificato con successo il ctDNA in pazienti privi di mutazioni BRAF e NRAS, suggerendo una maggiore applicabilità rispetto agli studi precedenti. I risultati hanno portato allo sviluppo del trial CLEAR-Me per la rilevazione e la pulizia della MRD nei pazienti con melanoma ad alto rischio.
NeoGenomics (NASDAQ: NEO) publicó un estudio en ESMO Open que demuestra la efectividad del DNA tumoral circulante (ctDNA) en el monitoreo de la enfermedad residual molecular (MRD) para pacientes con melanoma de alto riesgo. La investigación, realizada con el Hospital Princess Margaret, analizó 276 muestras de plasma de 66 pacientes con melanoma utilizando el ensayo de secuenciación RaDaR® de NeoGenomics.
El estudio reveló que la detección de ctDNA post-cirugía puede identificar a los pacientes con un pronóstico peor y permitir la detección más temprana de la recidiva de la enfermedad. Notablemente, la investigación identificó con éxito ctDNA en pacientes sin mutaciones en BRAF y NRAS, lo que sugiere una mayor aplicabilidad en comparación con estudios anteriores. Los hallazgos llevaron al desarrollo del ensayo CLEAR-Me para detectar y eliminar MRD en pacientes con melanoma de alto riesgo.
NeoGenomics (NASDAQ: NEO)는 ESMO Open에 고위험 흑색종 환자의 분자 잔여 질병(MRD) 모니터링에서 순환 종양 DNA(ctDNA)의 효과를 입증한 연구 결과를 발표했습니다. 이 연구는 Princess Margaret 병원과 협력하여 NeoGenomics의 RaDaR® 시퀀싱 분석을 사용하여 66명의 흑색종 환자에서 276개의 혈장 샘플을 분석했습니다.
연구 결과, 수술 후 ctDNA 검출은 나쁜 예후를 가진 환자를 식별하고 질병 재발을 조기에 발견할 수 있도록 해준다는 사실이 밝혀졌습니다. 특히, 연구는 BRAF 및 NRAS 변이가 없는 환자에서 ctDNA를 성공적으로 식별하여 이전 연구에 비해 더 넓은 적용 가능성을 시사합니다. 이러한 발견은 고위험 흑색종 환자의 MRD를 감지하고 제거하기 위한 CLEAR-Me 임상 시험 개발로 이어졌습니다.
NeoGenomics (NASDAQ: NEO) a publié une étude dans ESMO Open démontrant l'efficacité de l'ADN tumoral circulant (ctDNA) dans le suivi de la maladie résiduelle moléculaire (MRD) chez les patients atteints de mélanome à haut risque. La recherche, réalisée en collaboration avec l'hôpital Princess Margaret, a analysé 276 échantillons de plasma provenant de 66 patients atteints de mélanome en utilisant le test de séquençage RaDaR® de NeoGenomics.
L'étude a révélé que la détection de ctDNA après la chirurgie peut identifier les patients ayant un pronostic moins favorable et permettre une détection précoce de la récidive de la maladie. Notamment, la recherche a réussi à identifier ctDNA chez des patients dépourvus de mutations BRAF et NRAS, suggérant une applicabilité plus large par rapport aux études précédentes. Les résultats ont conduit au développement de l'essai CLEAR-Me pour détecter et éliminer la MRD chez les patients atteints de mélanome à haut risque.
NeoGenomics (NASDAQ: NEO) veröffentlichte eine Studie in ESMO Open, die die Wirksamkeit von zirkulierendem Tumor-DNA (ctDNA) zur Überwachung von molekularem Restkrankheit (MRD) bei Hochrisiko-Melanom-Patienten demonstriert. Die Forschung, die in Zusammenarbeit mit dem Princess Margaret Hospital durchgeführt wurde, analysierte 276 Plasmaproben von 66 Melanom-Patienten unter Verwendung des RaDaR® Sequenzierungsassays von NeoGenomics.
Die Studie ergab, dass die Erkennung von ctDNA nach der Operation Patienten mit schlechterer Prognose identifizieren und eine frühere Erkennung von Krankheitsrückfällen ermöglichen kann. Bemerkenswerterweise identifizierte die Forschung erfolgreich ctDNA bei Patienten ohne BRAF- und NRAS-Mutationen, was auf eine größere Anwendbarkeit im Vergleich zu früheren Studien hinweist. Die Ergebnisse führten zur Entwicklung der CLEAR-Me-Studie zur Erkennung und Beseitigung von MRD bei Hochrisiko-Melanom-Patienten.
- Successfully demonstrated broader applicability of ctDNA testing technology compared to existing methods
- Research findings led to development of new clinical trial (CLEAR-Me)
- Technology shows potential to expand addressable market by working with tumors lacking BRAF and NRAS mutations
- None.
Insights
This clinical research demonstrates significant progress in melanoma monitoring using ctDNA technology. The study's scope, involving 276 plasma samples from 66 melanoma patients, provides robust data supporting RaDaR®'s effectiveness in detecting molecular residual disease. The key breakthrough lies in the technology's ability to identify ctDNA in patients lacking BRAF and NRAS mutations, expanding its utility beyond traditional detection methods.
The potential clinical impact is substantial, particularly given that melanoma recurrence rates range from
This development strengthens NeoGenomics' competitive position in the precision oncology market. RaDaR®'s demonstrated effectiveness in a broader patient population than existing technologies creates a significant market opportunity. With over 100,000 melanoma cases in 2023 and high recurrence rates, the potential market for monitoring services is substantial.
The study's publication in ESMO Open adds credibility and could accelerate clinical adoption. The progression to the CLEAR-Me trial indicates potential commercialization pathway, which could translate into revenue growth. This advancement positions NeoGenomics favorably in the growing liquid biopsy market, particularly in the high-value melanoma segment.
Melanoma impacted over 100,000 patients in 2023; the majority (
Many earlier ctDNA studies in melanoma utilized technologies that target a narrow spectrum of recurrent driver alterations, an approach that limits application in patients with tumors lacking BRAF and NRAS mutations. In contrast, the study successfully identified ctDNA in patients with tumors lacking BRAF and NRAS mutations, suggesting that this tumor-informed approach may be informative in a wider range of patients.
“There is an urgent need for dependable biomarkers to define recurrence risk and identify melanoma patients who would benefit most from adjuvant treatment, as no reliable criteria currently exist to guide therapy selection,” said Warren Stone, Chief Commercial Officer at NeoGenomics. “This study highlights the value of ctDNA in addressing this gap and provides a foundation for future research and integration into routine clinical care, aiming to improve patient outcomes.”
This study is an example of the potential applications of ctDNA for the implementation of novel therapeutic strategies aimed at improving the care of cancer patients, and findings have led to the development of the CLEAR-Me trial, an interception study to detect and clear MRD in patients with high-risk melanoma (NCT06319196).
About NeoGenomics, Inc.
NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in
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Source: NeoGenomics, Inc.
FAQ
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