FDA gives Seegene test kits green light in the U.S.Seegene’s novel coronavirus diagnostic kit won an emergency use approval from the U.S. Food and Drug Administration (FDA) Wednesday, making it the second test kit from Korea to win the qualification.
The FDA gave Seegene’s Allplex 2019-nCoV Assay an emergency use authorization to be used in diagnosing Covid-19 cases in the United States, a country that continues to struggle with the world’s worst outbreak of the deadly virus.
Last weekend, Osang Healthcare became the first Korean company to win the emergency authorization from the U.S. regulator, which gave the green light to its GeneFinder Covid-19 Plus RealAmp Kit. The FDA has thus far approved the use of more than 40 companies’ coronavirus test kits.
“We feel that it is our duty to help society with our technology in this time of need. We are incredibly proud to be providing the Seegene Assay, which represents the leading edge of testing technologies,” Seegene CEO Chun Jong-yoon said in a statement.
Using the official name of the coronavirus that causes Covid-19, he added, “We will continue to stay prepared for any modifications required to ensure the most accurate detection of the mutative SARS-CoV-2.”
Seegene said its test kit also is combined with a unique automated solution that can allow tests to be run in high volumes.
Local test kit makers including Seegene and Osang Healthcare had already been shipping their test kits to the United States before earning the FDA’s emergency approval after the drug authority provided unprecedented regulatory relief in mid-March.
As the demand for Covid-19 diagnostic solutions soared, the FDA relaxed its normally tight restrictions by allowing individual states to authorize use of diagnostic kits without engagement with the FDA.
Many are expecting that more diagnostic kits from Korea will earn the same approval in the coming days as U.S. demand for testing solutions remains high.
The country reported a total of 825,041 confirmed Covid-19 cases and 45,063 deaths as of Wednesday afternoon, according to data from Johns Hopkins University. About 4.16 million tests have been conducted in the United States so far, but governors and health authorities have been demanding far more to control the outbreak, reaching out to a number of other countries including Korea for imports.
According to the Blue House, U.S. President Donald Trump requested Covid-19 diagnostic kit support from Korean President Moon Jae-in in a phone conversation late last month.
Trump reportedly promised action on FDA approvals for Korean medical equipment “today,” and the Blue House said Moon promised “maximum support” to the country that has so far reported the largest number of confirmed cases in the world.
But questions remain as to whether Korean diagnostic solutions will see meaningful sales as the FDA continues to hand out emergency authorizations to Covid-19 testing solutions.
On Tuesday, the FDA issued its first authorization for a U.S. company’s Covid-19 test kit, made by LabCorp. The test allows people to swab their nose to collect a fluid sample and send the samples to a lab for testing.
BY KO JUN-TAE [email@example.com]
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