SolGent, an affiliate of EDGC announced on the May 25 that it has received Emergency Use Authorization from both U.S. Food and Drug Administration and KCDC on its COVID-19 testing kits, becoming the 3rd Korean kit to obtain approval from the agency. The product also acquired European CE-IVD approval.

“SolGent’s COVID-19 diagnostic kits obtained sales approval in dozens of countries including Canada, Philippines, Mexico, Thailand, India, Taiwan and Malaysia. With the approvals that we need, we are ready to supply the products to federal governments, states and any medical facilities without any restrictions.” EDGC said.

SolGent’s DiaPlexQ™ Novel Coronavirus (2019-nCoV) detection kit has already been supplied to more than 50 countries, including top COVID-19 infection countries such as the United States, Russia, and Brazil. The kit was supplied to the Federal Emergency Management Agency (FEMA) for the first time as Korean company.

Since the company began manufacturing test kits for 300,000 people per week in this year in order to meet the needs of each country, it has gradually increased the production to 1 million test kits per week by the support of the KBIZ Korea Federation of SMEs and Samsung Electronics called ‘Smart Factory Program’. The company is building an automated system with the aim of producing 3 to 5 million test kits per week within June. SolGent plans to produce 10 million test kits per week from newly manufactured facility.

“To mass-produce COVID-19 diagnostic kits, stable raw material production, securing subsidiary ingredients, automation of production facilities and improvement of processes are essential.” said by co-CEO You Jae-hyung of SolGent. “SolGent produces three of the key raw materials for the manufacture of COVID-19 testing kits. It signed a tech-transfer contract with Genofocus for the mass production system of the core ingredients and agreed on a supply contract with Genotech and Noble Bio as well. We also completed a procurement with domestic tube makers, which will give us more advantages in the global market.” he added.

“We are pushing for long-term contracts with several countries and the new plant will be able to produce a large number of high-quality products that can diagnose various infections such as colds, flu, respiratory viruses, pneumonia, and tuberculosis. Through this arrangement, we will be able to provide the products in a stable manner. We have also prepared a product that can diagnose all kinds of mutations of COVID-19, further enhancing the convenience and accuracy.” he stressed.

Meanwhile, SolGent is the only company that has received approval for emergency use in Korea to produce COVID-19 diagnostic reagents with localized materials. The company combines its own technology and know-how into quality management such as ISO9001, ISO 13485 and KGMP.