[Exclusive] Domestic Diagnostic Kits to Be Exported to the US... Solgent to Supply 500,000 Tests to the US, Europe, and More

SolGent Receives Letter of Intent from US Distributors

Purchase Intent from UCLA Medical Center and Others

US Export May Take Place as Early as Tomorrow

Dispelling Safety Concerns over 'Korean Diagnostic Kits'

Yoo Jae-hyung, CEO of Solgent

[Asia Economy Reporter Jeong Dong-hoon] Domestic COVID-19 diagnostic kits are set to be exported to the United States.

Yoo Jae-hyung, CEO of SolGent, a developer of COVID-19 diagnostic kits and reagents, said in a phone interview with Asia Economy on the 16th, "We will export 5,000 kits (enough for 500,000 people) to several countries including the US and Europe," adding, "If all goes well, we expect to supply the diagnostic kits to the US by air as early as the 17th." Previously, SolGent secured export volumes by receiving letters of intent from US companies.

The kit product developed by SolGent, 'DiaplexQ Novel Coronavirus,' received emergency use authorization from the Ministry of Food and Drug Safety on the 27th of last month, and on the 29th of the same month, it also obtained European certification for the same product. This kit can extract two COVID-19 virus genes and simultaneously detect them within two hours.

Institutions intending to purchase SolGent's products include medical centers such as the University of California, Los Angeles (UCLA) Medical Center. SolGent is also participating in diagnostic kit procurement bids from state governments including California and Maryland.

These buyers have pursued purchasing Korean diagnostic kit products in response to the COVID-19 outbreak phase, independently of US FDA approval. SolGent has contracted with a local consulting firm and is also undergoing the FDA approval process.

A Solgent researcher conducting research related to diagnostic kit products

This export is significant in dispelling concerns about the safety of domestic diagnostic kits. On the 11th (local time), Mark Green, a Republican member of the Tennessee House of Representatives, claimed at a House Oversight Committee hearing that "the US FDA stated via email that 'Korean COVID-19 diagnostic kits are inappropriate and do not agree to their use in the US, even for emergency purposes,'" sparking controversy.

However, the antibody testing method cited by Representative Green was confirmed to be different from the methods used by four companies, including SolGent, which received temporary use approval from the Korea Disease Control and Prevention Agency. The Korean Society for Laboratory Medicine stated the previous day, "The diagnostic kits mentioned in the FDA's written communication refer to antibody testing methods, not the gene detection testing methods currently used domestically," emphasizing, "There is no issue with the accuracy of the diagnostic kits currently in use in Korea."

In fact, the kits used domestically for COVID-19 diagnosis employ a single method based on gene detection testing. Although some diagnostic kits using antigen-antibody reactions have been developed, they have not yet received emergency use authorization from the government. CEO Yoo said, "We have already sent test kits to local US companies and received positive evaluations," adding, "Once we receive FDA approval, export volumes will increase even faster."