• GENOMICA receives the approval of the Korean health authorities (KFDA) for the commercialization of CLART® kits and the autoclart® plus equipment in South Korea.
• The Spanish diagnostic company will enter the South Korean market together with AGBIO Diagnostics.
Madrid, November 02, 2017. GENOMICA, a leading molecular diagnostics company belonging to the PharmaMar Group (MSE: PHM), has announced that it has received authorization in South Korea for commercializing CLART® in vitro diagnostic kits together with the autoclart® plus equipment by the competent healthcare authorities (KFDA, for its acronym in English).
This authorization comes after the audit carried out to GENOMICA where it was verified that the company’s facilities, the technical documentation and the quality system of the instruments and kits complyed with the Korean Good Manufacturing Practices.
“Once we obtained the favorable dictum of the Korean authorities, we initiated the procedures to register the products and instruments. Today, we have marketing authorization in South Korea, which is an important milestone for us as it is one of the most demanding accreditation bodies in the world and because it contributes to our expansion in Asia-Pacific “, explains Rosario Cospedal, General Director of GENOMICA.
GENOMICA has reached an agreement with the South Korean diagnostics company AGBIO Diagnostics for the distribution of kits and instruments in this country.
GENOMIC is the first Spanish company in Molecular Diagnostics and highly experienced in the analysis of genetic identification. Founded in 1990, with facilities in Madrid, GENOMICA is 100% owned by PharmaMar. It is our mission to improve the present molecular diagnostics tools and the human identification methods through reliability, automation and the highest quality standards. Our main objective is to maintain leadership in genomics applications within the Spanish market, and to extend internationally our activities in the area of Molecular Diagnostics by means of the design, development, automation, and commercialization of new diagnostic applications of our innovative technological platform, Clinical Arrays Technology, CLART®
GENOMICA has developed diagnostic tests for human papillomavirus associated with cervical cancer, the diagnosis of viral respiratory diseases, multiple detection of human herpes and enteroviruses, as well as detection of gene regions associated to the determination of human therapy response factors, in particular in the Oncology field.
GENOMICA also provides analysis of DNA, Legal and Forensic Medicine, and Technology Transfer services.
About AGBIO Diagnostics:
AGBIO Diagnostics is the company in charge of distributing GENOMICA’s kits and instruments in South Korea. This company, established in 1994, is specialized in genetic tests for infectious diseases diagnostics. It manufactures microarrays to detect Enteric Virus, drug resistance of Tubercular Bacillus and sexually transmitted diseases. Its corporate vision consist in relying on the potential of molecular diagnostics as a solid foundation for focusing their efforts on the development of innovative technology.
This document does not constitute or form part of any offer or invitation to sell or request any question of the purchase, offer or subscription of shares of the Company. Likewise, this document, or its distribution, is or may be part of the basis for any investment decision or contract and does not constitute any type of recommendation in relation to the Company’s shares.
For more information, write us at: