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Validación analítica y clínica de CancerMaster, un panel NGS automatizado dirigido, para la oncología de precisión
Jingmin Che1, Woo Sun Kwon1, Jaeyoung Kim2
1Song-dang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, Republic of Korea.
Scientific reports
|February 10, 2026
Resumen
El panel de secuenciación de próxima generación de CancerMaster ofrece un perfil molecular integral para tumores sólidos, detectando varias alteraciones genómicas e infecciones de manera eficiente. Muestra una alta precisión y concordancia, apoyando las decisiones personalizadas de tratamiento del cáncer.
Área de la Ciencia:
- Oncología Oncología.
- La genómica es la genómica.
- Biología Molecular Biología Molecular
Sus antecedentes:
- La secuenciación de próxima generación (NGS, por sus siglas en inglés) permite un perfil molecular completo de tumores sólidos.
- Los enfoques NGS existentes pueden enfrentar retrasos en el análisis y la presentación de informes.
- El perfil molecular multidimensional es crucial para el tratamiento personalizado del cáncer.
Objetivo del estudio:
- Desarrollar y validar el panel CancerMaster NGS para el perfil de tumores sólidos.
- Para establecer una tubería de análisis automatizado para reducir el tiempo de respuesta.
- Evaluar la utilidad clínica del panel CancerMaster en una cohorte de pacientes.
Principales métodos:
- Desarrollo de un panel de NGS dirigido a 524 genes (CancerMaster).
- Establecimiento de una tubería de análisis asíncrona, paralela y automatizada con informes.
- Validación utilizando materiales de referencia y análisis de una cohorte de 668 pacientes.
- Comparación con el panel de TruSight Oncología 500 (TSO500).
Principales resultados:
- CancerMaster demostró una reproducibilidad del 100%, una sensibilidad analítica del 99% y una precisión del 94%.
- El panel detectó variantes de un solo nucleótido / indels, CNV, fusiones, infecciones virales, MSI, TMB y tipificación de HLA.
- Se identificaron mutaciones accionables y VNC en cánceres gástricos y colorrectales.
- Se observó una alta correlación entre MSI y TMB (r=0.75, p<10^-15).
- CancerMaster mostró una alta concordancia con TSO500, identificando de manera única las alteraciones de ERBB2.
Conclusiones:
- El panel CancerMaster proporciona un rendimiento analítico robusto para el perfil molecular multidimensional de tumores sólidos.
- La tubería automatizada supera los retrasos en los enfoques NGS existentes.
- CancerMaster tiene un fuerte potencial clínico para guiar la terapia personalizada contra el cáncer.
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