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Hay más de 500.000 casos de cáncer de vejiga en los EE.UU., y más de 70.000 nuevos casos son diagnosticados cada año. El cáncer de vejiga tiene la mayor tasa de recurrencia de todos los cánceres. Como resultado, un gran porcentaje de los pacientes tienen toda la vida, frecuentes y costosos procedimientos de seguimiento (cistoscopia y biopsia) para detectar la recurrencia y progresión tumoral. Este seguimiento de la enfermedad por toda lavida hace que el cáncer de vejiga es el cáncer más costosa en función de cada paciente. La mayoría de los pacientes (70%) presentan tumores superficiales y el cáncer pueden ser tratados eficazmente. Los tumores superficiales (Ta/T1) están manejados básicamente a través de métodos ahorradores de la vejiga con cistoscopia, RTU-T (resección transuretral de tumor de la vejiga) y el tratamiento intravesical (es decir, BCG). Con tumores invasivos del músculo (T2 y superiores), la cistectomía es la estrategia principal.

Las decisiones de gestión de pacientes dependen en gran medida una clasificación clínica correcta y de la clasificación de las muestras de biopsia o TURB-T. Desafortunadamente, los estudios han demostrado que la estadificación clínica sub-classifica para una menor etapa un tumor de vejiga en comparación con la estadificación de la patología y la clasificación de hecha después de la cistectomía. Por ejemplo, hasta el 40% de los tumores suponidos que sean T1 (no músculo invasivo) han demostrado ser invasivos del músculo, cuando después de la estadificación de cistectomía de la patología se realiza poco tiempo después.

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Porque una clasificación correcta tiene implicaciones importantes para la correcta evaluación de la agresividad de un tumor y para las decisiones de manejo del paciente, Metabolon está desarrollando una prueba a base de tejido para determinar la agresividad de tumores de vejiga a través de una puesta en escena bioquímicos de las muestras de tumor. Esta prueba detecta firmas metabólicos asociados con tumores conocidos por ser agresivos (T2), por estadiamentos post-cistectomía patológicos en las muestras de TURB-T/biopsy. Esta información dará a los médicos un mayor nivel de confianza a la hora de tomar decisiones de gestión de pacientes (es decir, seguir una estrategia de la vejiga para preservar la vigilancia activa u optar por una estrategia más agresiva participación de cistectomía).

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El diagnóstico de la recurrencia del cáncer de vejiga se basa en la visualización cistoscópica frecuente, invasiva y costosa de los tumores de vejiga y el uso de algunos marcadores biológicos adjunto (es decir, la citología, FISH) para ayudar en ciertos casos, en su mayoría de alta calidad. Metabolon trabaja en el desarrollo de una manera no invasiva basada en la orina de prueba para detectar metabolitos asociados con los tumores de vejiga con una alta especificidad, independientemente de la etapa y el grado del cáncer. Esta prueba se utiliza para guiar el manejo del paciente, las decisiones durante la vigilancia activa, y puede ser utilizado como una prueba de gating inicial o de seguimiento cistoscopias y otros procedimientos invasivos.

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Después del cáncer de vejiga ser diagnosticado y los pacientes tratados por TURB-T o la cistectomía, los médicos determinan si hay signos de recidiva local y metastásica, a intervalos regulares. Lesiones metastásicas muy pequeñas, conocidas como micro-metástasis, son generalmente asintomáticos y que no se puedan detectar en las pruebas de imagen como una tomografía computarizada o una resonancia magnética hasta alcanzar un tamaño más grande. Si estos micro-metástasis se detectan antes, los médicos pueden tratar al paciente antes. Metabolon está desarrollando una prueba para detectar la presencia de metástasis ocultas y asintomáticas basado en un panel de metabolitos en sangre u orina. Esta prueba está destinada para su uso en el tratamiento de seguimiento, que establecerá, ya sea junto con las pruebas de imagen estándar o como una puerta a las pruebas de imagen. La identificación de la enfermedad metastásica antes ofrece a los médicos información adicional para elegir el tratamiento más adecuado para cada paciente.

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