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Seegene signs big U.S. test kit deal

Using FDA loophole, the company makes sale to Los Angeles
Mar 26,2020
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President Moon Jae-in, right, talks with Seegene CEO Chun Jong-yoon, left, Wednesday during the president’s visit to the diagnostic kit manufacturer’s office in Seoul following his phone conversation with U.S. President Donald Trump. [NEWS 1]
Seegene is exporting at least 20,000 coronavirus diagnostic kits to Los Angeles, as the United States scrambles to fight an outbreak that Korea has battled effectively.

The company took advantage of a regulatory loophole that has just been opened by U.S. authorities to cut red tape and allow for the immediate importing of the much-needed diagnostic equipment.

Los Angeles County said late Tuesday night that it signed a $1.25 million deal to buy the Covid-19 test kits from Seegene Technologies, the U.S. subsidiary of the Korean point-of-care diagnostic company.

The kits themselves will come directly from Korea.

Los Angeles County is in discussion with Seegene to buy more test kits. Test kits will be supplied to medical professionals and paramedics.

A lack of diagnostic solutions has slowed the response in the United States and may have contributed to the rapid rise in the number of cases. According to Johns Hopkins University, the United States reported a total of 53,740 confirmed cases and 706 deaths from the novel coronavirus in 54 states and territories by noon Wednesday.

Los Angeles County has reported 662 confirmed cases and 11 deaths from Covid-19. It has been struggling to run tests due to the shortage of diagnostic kits.

No diagnostic kit from a Korean company has received an emergency use approval (EUA) from the U.S. Food and Drug Administration (FDA), but the health authority did provide limited exemptions last week for companies looking to sell Covid-19 test kits.

The health administration, which is normally highly cautious, is allowing individual states to authorize use of diagnostic kits without engagement with the FDA.

“The FDA is aware that numerous commercial manufacturers are developing tests for coronavirus with the intention of submitting an EUA to the FDA,” the FDA said in a statement last week.

The authority said it “does not intend to object to the distribution of use of these tests” while test kit manufacturers prepare their EUA requests, saying “15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.”

Seegene said Wednesday that it has already navigated the pre-submission process and filed an EUA request with the FDA.

The company has already been exporting its Covid-19 test kits to the United States for research purposes, which is possible without FDA approval, according to a company sales official.

Seegene’s Allplex 2019-nCoV Assay was the second Covid-19 test kit to earn an EUA from Korea’s Ministry of Food and Drug Safety. The kit was also authorized for export, and Seegene is at the moment selling the test kit to 40 countries.

The company has the capacity to produce 100,000 kits per day.

Tests kits have been a topic of conversation between President Moon Jae-in and U.S. President Donald Trump, according to the Blue House.

In a phone conversation Tuesday, Trump promised action on FDA approvals for Korean medical equipment “today.”

The Blue House added that Moon promised “maximum support” to the United States.

On Wednesday afternoon, Moon visited Seegene’s office in Seoul and promised that his government will help facilitate the export of diagnostic materials. During the meeting with heads of five Covid-19 diagnostic solution manufacturers - Seegene, Kogene Biotech, SolGent, SD Biosensor and BioSewoom - Moon lauded the companies for being “at the forefront of efforts to overcome the virus.”

Following the conversation between Trump and Moon and the Korean president’s meeting with diagnostic kit companies, the share price of Kosdaq-listed Seeguaene skyrocketed by its daily limit of 30 percent to close at 88,100 won ($71) by Wednesday’s close.

It is now the third-largest Kosdaq company by market capitalization.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]