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Seegene presenta el primer ensayo PCR "3 Ct" comercializado en el mundo
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Seegene Inc.

Apr 26, 2022, 19:21 ET

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  • Proporciona el valor Ct de tres objetivos en un canal; el ensayo PCR '3 Ct' se lanzará en el primer semestre
  • "Tecnología Dream MDx" desarrollada sobre la base de los 20 años de experiencia de Seegene; combina 19 tecnologías patentadas diferentes, incluyendo DPO™, TOCE™, MuDT™
  • '3 Ct' sentará las bases de las pruebas sindrómicas automatizadas y hará que MDx sea más accesible

SEUL, Corea del Sur, 27 de abril de 2022 /PRNewswire/ -- Seegene Inc. (KQ096530), empresa surcoreana líder en diagnóstico molecular (MDx), ha anunciado hoy el desarrollo del primer ensayo de PCR comercializado en el mundo que aplica la tecnología "3 Ct". El "Allplex™ HPV HR Detection" se presentó en el Congreso Europeo de Microbiología Clínica y Enfermedades Infecciosas (ECCMID) de 2022, celebrado del 23 al 26 de abril en Lisboa (Portugal).

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[Figure 1] Seegene unveils world's first commercialized '3 Ct' PCR assay
[Figure 1] Seegene unveils world's first commercialized '3 Ct' PCR assay

En una reacción en cadena de la polimerasa (PCR), el valor del umbral de ciclo (Ct) se utiliza para cuantificar la concentración de una secuencia de ADN viral (el objetivo). Debido a las limitaciones tecnológicas, la técnica convencional de PCR en tiempo real encuentra el valor Ct de un objetivo en un canal.

Pero la tecnología '3 Ct' de Seegene puede proporcionar el valor Ct de tres objetivos en un canal sin comprometer la sensibilidad y la especificidad. El exitoso desarrollo se basa en los 20 años de experiencia de Seegene y combina 19 tecnologías patentadas diferentes, incluyendo DPO™, TOCE™ y MuDT™. Utilizando cinco canales en un solo tubo, Seegene puede proporcionar datos cuantitativos para un total de 15 objetivos. '3 Ct' ha sido bautizada como la "tecnología MDx soñada".

La empresa tiene previsto aplicar la tecnología '3 Ct' a toda su gama de productos, incluidos los ensayos de virus respiratorios (VR), infecciones de transmisión sexual (ITS), infecciones gastrointestinales (IG) e infecciones del tracto urinario (ITU). Seegene espera que la tecnología "3 Ct" lleve las pruebas sindrómicas a otro nivel. Al detectar el patógeno causante, el nivel de infección y la posible coinfección, ayudará a determinar la prioridad del tratamiento y a mejorar el manejo del paciente. La tecnología "3 Ct" también aumenta la capacidad de las pruebas. Se espera que estas características mejoren el servicio y la estructura de costes del sector médico una vez que la tecnología "3 Ct" se utilice ampliamente.

El primer producto de Seegene aplicado a la tecnología '3 Ct', Allplex™ HPV HR Detection, está diseñado para detectar 14 tipos de virus del papiloma humano (VPH) de alto riesgo que pueden causar cáncer de cuello uterino (véase la figura 1). También proporciona el valor Ct individual de cada uno de los tipos permitiendo un análisis cuantitativo respecto al nivel de infección. La detección precoz del VPH contribuye a la prevención y el tratamiento del cáncer de cuello de útero. Los productos de VPH de otras empresas del sector proporcionan valores Ct individuales para dos tipos de alto riesgo, el VPH 16 y el 18.

El Allplex™ HPV HR Detection, cuyo lanzamiento está previsto para el primer semestre de este año, tendrá una importante ventaja de costes en comparación con los productos existentes para el VPH, con el fin de aumentar la accesibilidad a las pruebas de PCR, que antes resultaban difíciles debido a los elevados costes. El producto también será compatible con el sistema totalmente automatizado AIOS (all-in-one system) de Seegene. La empresa tiene previsto presentar el primer "sistema de pruebas sindrómicas totalmente automatizado y masivo" de la industria, para sentar las bases de la realización de pruebas en cualquier lugar, incluidos grandes hospitales, C-Labs e incluso clínicas pequeñas y medianas, y hacer que las pruebas de PCR formen parte de la vida cotidiana.

"El genotipado del VPH es esencial para realizar un buen seguimiento de un paciente, a fin de observar la aparición, la persistencia o la eliminación de cada genotipo", afirmó el experto en VPH Sebastien Hantz, profesor de la Facultad de Medicina de la Universidad de Limoges (Francia). "Seegene es una empresa muy implicada en el desarrollo de pruebas de diagnóstico molecular para la detección de diferentes patógenos. Para determinadas situaciones clínicas, como las infecciones respiratorias, las pruebas sindrómicas son muy útiles."

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