GENOMICA Receives Authorization for the Commercialization of its Diagnostic Kits and Instruments in South Korea

Food and Healthcare Press Releases Tuesday November 14, 2017 08:30
MADRID--14 Nov--PRNewswire/InfoQuest

GENOMICA, a leading molecular diagnostics company belonging to the PharmaMar Group (MCE: PHM), has announced that it has received authorization in South Korea for commercializing CLART(R) in vitro diagnostic kits together with the autoclart(R) plus equipment by the competent healthcare authorities (KFDA, for its acronym in English).

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

This authorization comes after the audit carried out to GENOMICA and after verifying that the company's facilities, the technical documentation and the quality system of the instruments and kits comply 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 sales 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.
About GENOMICA

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(R)

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.

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

Latest Press Release

Merck Awarded Australian CRISPR Nickase Patent for Foundational Genome-Editing Technology

- Patent covers paired Cas9 nickase technology to reduce off-target effects, advance gene therapy and research - Expands company's foundational CRISPR cutting and integration IP necessary to correct genetic defects in gene therapy patients - Merck to...

Kaneka officially starts continuous manufacturing under GMP

Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Mamoru Kadokura) have installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore Co. (Pte.) Ltd, (Headquarters: Singapore; President: Kazuhiko...

TIENS Group opens new high-tech Experience Store in Shenzhen

TIENS Group, one of leading corporations in the Healthcare industry, unveiled a new high-tech Customer Experience Store in Shenzhen. Li Jinyuan, founder and chairman of TIENS group, announced the official opening of its first store in the world on August...

Sotera Health#s Nordion completes the sale of its medical isotopes business to BWXT

- Nordion's increased focus on gamma technologies supports Sotera Health's company-wide commitment to Safeguarding Global Health(TM) Sotera Health LLC, the world's leading, fully integrated protector of global health, today announced the closing of the...

Menarini Ricerche to Sponsor Cancer Trial in Acute Myeloid Leukemia in USA

Menarini Ricerche, a company of the Menarini Group, announced today that the sponsorship of the ongoing Phase I/II study that is investigating MEN1703/SEL24 for the treatment of patients with relapsed/refractory (R/R) AML in the USA has been transferred...

Related Topics