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GENOMICA recibe la autorización de comercialización de sus kits de diagnóstico y equipos en Corea del Sur
  • India - English
  • USA - Français
  • USA - Deutsch


News provided by

PharmaMar

Nov 14, 2017, 01:30 ET

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MADRID, November 14, 2017 /PRNewswire/ --

GENOMICA, compañía del grupo PharmaMar, la compañía líder en diagnóstico molecular y perteneciente al Grupo PharmaMar (MCE:PHM), ha anunciado que ha recibido la autorización de comercialización en Corea del Sur de los kits de diagnóstico in vitro CLART® junto con el equipo autoclart® plus, por parte de las autoridades sanitarias competentes (KFDA, por sus siglas en inglés).

Pharma Mar SA (PRNewsFoto/Pharma Mar SA)
Pharma Mar SA (PRNewsFoto/Pharma Mar SA)

     (Logo: http://photos.prnewswire.com/prnh/20150203/727958-b )

Dicha autorización llega tras  la auditoría realizada a GENOMICA y tras comprobar que las instalaciones de la compañía, la documentación técnica y el sistema de calidad de los equipos y kits cumplen con las Buenas Prácticas de Fabricación de Corea (Korean Good Manufacture Practices).

"Una vez que obtuvimos el dictamen favorable de las autoridades coreanas, procedimos a iniciar los trámites para registrar los productos y equipos. A día de hoy, tenemos luz verde para su venta en Corea del Sur, lo que significa un hito importante para nosotros al ser uno de los organismos más exigentes del mundo y porque contribuye a nuestra expansión por Asia-Pacífico", explica Rosario Cospedal, directora general de GENOMICA.

GENOMICA ha llegado a un acuerdo con la empresa de diagnóstico surcoreana AGBIO Diagnostics para la distribución de los kits e instrumentos en este país.

Sobre GENOMICA 

GENOMICA es la primera compañía española en diagnóstico molecular y con gran experiencia en la realización de análisis de Identificación Genética. Fundada en 1990, se ubica en la Comunidad de Madrid y está participada al 100% por el Grupo PharmaMar. Nuestra misión es mejorar los métodos actuales de diagnóstico molecular e identificación genética con herramientas fiables, automáticas y de acuerdo a los más altos estándares de calidad. El principal objetivo de la compañía es continuar liderando las aplicaciones genómicas en el mercado español y extender internacionalmente nuestras actividades en el área del diagnóstico molecular, mediante el diseño, desarrollo y comercialización de nuevas aplicaciones diagnósticas de nuestra innovadora plataforma tecnológica CLINICAL ARRAYS TECHNOLOGY, CLART®. GENOMICA ha desarrollado tests de diagnóstico de numerosas enfermedades infecciosas y varios tipos de tumores así como tests para la detección de regiones génicas en humanos asociadas a respuestas a terapias, en concreto en el campo de la oncología. Otro campo donde GENOMICA apuesta con fuerza, es llevando a cabo servicios de análisis de ADN en Medicina Legal y Forense, y en transferencia de tecnología. Para más información, visite nuestra web:  http://www.genomica.es.

CONTACTS : Media Relations (+34-638-79-62-15) and Investor Relations (+34-914444500)

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