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Roche anuncia la indicación de marca CE expandida para la prueba del VPH cobas® 4800

- Roche anuncia la indicación de marca CE expandida para la prueba del VPH cobas® 4800 apoyando su uso para la exploración primaria del cáncer cervical  

-- La detección del ADN del VPH encuentra la enfermedad que no detecta la citología Pap

PLEASANTON, California, 28 de noviembre, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) ha anunciado hoy una indicación de marca CE expandida para la prueba del VPH cobas® 4800. La indicación recientemente expandida para la prueba del VPH cobas® 4800 como exploración primaria significa que ya no se requiere la citología Pap como un test conjunto o previo en países que acepten una marca CE. La infección persistente con el papilomavirus humano es la principal causa de cáncer cervical en mujeres. La indicación expandida está respaldada por los datos que se presentarán en la International Papillomavirus Conference, del 30 de noviembre al 6 de diciembre de 2012, en San Juan, Puerto Rico.

"La prueba del VPH ofrece un nivel más sensible de exploración que la prueba Pap. Mientras que la citología busca células anormales, una prueba VPH busca la presencia de ADN del VPH", dijo Eduardo Franco, director, de la División de Epidemiología del Cáncer, McGill University, Montreal, Canadá. "La prevalencia de VPH significa que muchas mujeres pueden tener resultado positivo, de modo que es importante identificar también las que más riesgo tienen de progresar a un cáncer cervical. La genotipificación para los tipos de VPH 16 y 18 ofrece una especificidad adicional suficiente para identificar a las mujeres de más riesgo y ahorra al resto posibles intervenciones innecesarias. Los dos genotipos de VPH, 16 y 18, suponen el 70% de los casos del cáncer cervical".

La prueba del ADN del HPV se ha utilizado más tradicionalmente como una co-prueba o test reflejo para un resultado citológico anormal o límite. Mientras que la exploración citológica ha reducido drásticamente la prevalencia de cáncer cervical en las últimas décadas, tiene limitaciones debido a la baja sensibilidad y la naturaleza subjetiva de la interpretación de los resultados. Sin embargo, los estudios muestran que la prueba del ADN del VPH es más sensible que la citología al detectar enfermedad, algo importante en una exploración de primera línea. En el estudio de referencia ATHENA, se muestra que la prueba del VPH cobas® 4800 encuentra enfermedad que no detecta la citología: 1 de cada 10 mujeres que dieron positivo en los genotipos de VPH 16 y 18 por la prueba del VPH cobas® 4800 de Roche ya presentaban evidencia de pre-cáncer cervical, aunque la citología fuera normal.  

Aproximadamente 275.000 mujeres en el mundo mueren de cáncer cervical cada año, y muchos países están en proceso de realizar pruebas de ADN del VPH como una sustitución para la citología. "Pasar al uso de la prueba del VPH cobas® 4800 como exploración primaria permite a los países implementar estrategias que detecten más enfermedad con menos intervenciones médicas, permite a los médicos tratar mejor a sus pacientes y reduce el coste económico para el sistema sanitario", dijo Paul Brown, jefe de Roche Molecular Diagnostics.

La prueba del VPH cobas® 4800 es la única prueba aprobada por la FDA validada clínicamente que simultáneamente proporciona resultados sobre los conocidos genotipos "de alto riesgo" y resultados individuales sobre los genotipos de mayor riesgo, HPV 16 y HPV 18, dando tres resultados en solo una prueba. La prueba del VPH cobas® 4800 tiene un proceso del flujo de trabajo de preparación de muestra totalmente automatizado, y funciones de eficiencia únicas que permite un mayor rendimiento, haciéndolo adecuado para programas de exploración de alto volumen.

"Como organización comprometida con la salud de la mujer, Roche Diagnostics se dedica a mantener a las mujeres sanas y mejorar el cuidado a los pacientes", dijo Paul Brown. "Combinada con nuestros productos desde la adquisición empresarial de mtm anunciada el año pasado, Roche cuenta con una amplia cartera de prevención del cáncer cervical que redefine la exploración del cáncer cervical y asesora con más efectividad sobre las decisiones de tratamiento a pacientes". 

Conferencia internacional sobre el virus del papiloma
Roche presentará los datos que respaldan la indicación expandida de la prueba de VPH cobas® 4800 así como la cartera del cáncer cervical más amplia de Roche en la Conferencia Internacional del Virus del Papiloma, del 30 de noviembre al 6 de diciembre de 2012 en San Juan, Puerto Rico.

Roche Satellite Symposium:  Translating Science into Primary Screening Practice
Lunes, 3 de diciembre, 12:30 PM1:45 PM, Puerto Rico Convention Center, Ballroom B

Primary HPV screening: Impact of varying the age of initiation on the performance of screening
Wright TC, Cox JT, Sharma A, Apple R, Behrens CM
Martes, 4 de diciembre, 2:00PM - 3:30PM, Room 208

3 Year cumulative incidence rates for high-grade cervical disease: Interim analysis from the ATHENA study
Castle PE, Wright TC, Stoler, MH, Zhang, Behrens CM
Martes, 4 de diciembre, 2:00PM- 3:30PM, Room 208

Intra-laboratory variation in the performance of liquid-based cytology; insights from ATHENA
Stoler MH, Wright TC, Apple R, Sharma A, Behrens CM
Martes, 4 de diciembre, 5:30PM - 7:30PM (Poster Session)

Acerca del estudio ATHENA
El estudio ATHENA de referencia de Roche para la prueba cobas® 4800 HPV es el mayor estudio de registro basado en EE.UU. para la exploración del cáncer cervical, incluyendo más de 47.000 mujeres.  

Acerca de la prueba de VPH cobas® 4800 y el sistema cobas® 4800

La prueba de VPH cobas® 4800 es una prueba cualitativa in vitro para detectar el virus del papiloma humano (VPH) en muestras de pacientes. La prueba utiliza la amplificación del ADN diana mediante reacción en cadena de la polimerasa (PCR) y la hibridación de ácidos nucleicos para detectar en un único análisis catorce genotipos de VPH de alto riesgo; identifica específicamente 14 tipos de VPH de alto riesgo, y al mismo tiempo detecta genéricamente los otros genotipos de alto riesgo (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 y 68). Actualmente está disponible en los EE.UU. y en todos los países que reconocen la marca CE.

El sistema cobas® 4800 está diseñado para ofrecer nuevos niveles de eficiencia analítica y relevancia diagnóstica. El sistema ofrece una automatización completa que no requiere la presencia de un operador y puede realizar hasta 282 pruebas en menos de 12 horas, lo que permite un análisis rápido de pruebas de cribado de infección por VPH que satisface las necesidades de la mayoría de laboratorios de análisis clínicos.

Acerca del virus del papiloma humano y el cáncer cervical
La infección persistente por el virus del papiloma humano (VPH) es la causa principal del cáncer de cuello de útero (cáncer cervical) en las mujeres; el VPH está implicado en más del 99% de los casos en todo el mundo. Según el Instituto Nacional del Cáncer estadounidense, cada año se dan en ese país 12.200 nuevos casos de cáncer cervical y se producen 4.210 fallecimientos por esa enfermedad. La Organización Mundial de la Salud estima que en todo el mundo son unos 470.000 los nuevos casos de cáncer cervical cada año.

Acerca de Roche
Roche, cuya sede central se halla en Basilea (Suiza), es una compañía líder del sector de la salud, centrada en la investigación y con la potencia combinada de la integración farmacéutica-diagnóstica. Roche es la mayor empresa biotecnológica del mundo y tiene medicamentos auténticamente diferenciados en las áreas de oncología, virología, inflamación, metabolismo y sistema nervioso central. Roche también es el líder mundial en diagnóstico in vitro, incluido el diagnóstico histológico del cáncer, y pionero en el control de la diabetes. La estrategia de Roche en medicina personalizada tiene como fin proporcionar medicamentos y herramientas diagnósticas que hagan posible mejoras tangibles de la salud, la calidad de vida y la esperanza de vida de los pacientes. En el año 2011, Roche tenía más de 80.000 empleados en todo el mundo e invirtió más de 9.000 millones de francos suizos en investigación y desarrollo. Las ventas alcanzaron la cifra de 42.500 millones de francos suizos. Genentech (Estados Unidos) es un miembro de plena propiedad del Grupo Roche. Roche posee una participación mayoritaria en Chugai Pharmaceutical (Japón). Para más información: www.roche.com.

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