This made 1-Drop the sixth South Korean company that earned this approval, which can be found in the EUA section of FDA's website. 1-Drop plans to accelerate their expansion to North American market
1-Drop, a South Korean Coronavirus test kit (COVID-19 qPCR Multi Kit) maker, received Emergency Use Authorization (EUA) from U.S. Food & Drug Administration (FDA) on May 11th.
This made 1-Drop the sixth South Korean company that earned this approval, which can be found in the EUA section of FDA’s website. 1-Drop plans to accelerate their expansion to North American market.
1-Drop received support in their application submission from Korea Innovation Center (KIC) Washington, D.C. (Director Jung-Hwan Moon) through ‘EUA approval assistant program for COVID-19 domestic biotech supplies’ at the end of March. This program was initiated by the KIC Washington Center in order to support domestic businesses with advanced technology, with the goal of obtaining U.S. FDA’s EUA approval, a prerequisite to enter into the US market.
“This EUA approval is not only a great achievement for 1-Drop, but also an opportunity to showcase in the US our biotech company’s advanced technology,” said Jung-Hwan Moon, Director General of the KIC Washington, D.C. “KIC Washington, D.C. will continue to support the companies even after the EUA approval, to ensure their successful entry into the US market. I also expect more positive results from other domestic test kit makers, that they successfully obtain EUA with the help of KIC’s program.”
The KIC Washington Center announced that they are preparing to launch a second program to support domestic companies that produce Personal Protective Equipment (PPE), in conjunction with the first ‘EUA approval assistant program for COVID-19 domestic biotech supplies.’ Application process for the second program is expected to start at the end of May and more details will be available on the KIC’s website. “We will continue to support our start-up companies so they can successfully break into the US market,” said Moon.
Source: Company Press Release