HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc. and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.

Both companies confirmed that they are preparing to apply for the approval. Kogene’s overseas business and marketing manager Bitna Lee told BioWorld that the company is seeking emergency use assessment and listing (EUAL) approval from the FDA, but it is “difficult to comment on timing to get an EUAL from the FDA.” Seegene likewise declined to comment further on its application.

The FDA announced that it had granted Emergency Use Authorizations to Hologic for its Panther Fusion SARS-COV-2 Assay, and to Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test on Mar. 16, 2020, three days after U.S. President Donald Trump declared a national public health emergency.

The two new products are part of a group of Korean kits approved by South Korea’s Ministry of Food and Drug Safety (MDFS) through its urgent-use license in conjunction with the Korea Centers for Disease Control and Prevention in February. These licenses are granted when medical devices needed to fight infectious diseases are not available or limited.

A tale of two test kits

Founded in 2000, Kogene’s Powercheck 2019-nCoV RT PCR kit was the first testing kit to receive a license, with Seegene, founded in September of the same year, receiving approval for its Allplex 2019-nCOV Assay test kit a week later on Feb. 12.

The two other approved kits were developed by fellow molecular diagnosis companies SD Biosensor and Solgent who received their approvals on Feb. 4 and Feb. 27. The fifth kit, Biosewoom Inc.’s Real-Q 2019-nCoV detection kit, received approval on March 13.

Seegene’s approval came a week before the outbreak of COVID-19 intensified in the southeastern city of Daegu on Feb. 18. The number of cases quickly climbed, leading to the unwelcome situation of being the country with the most cases behind China. The World Health Organization (WHO) reported 8,413 cases and 84 deaths in the country as of March 18.

Yohan Park, Seegene’s head of investor relations, explained to BioWorld that “strong memories of infectious disease outbreaks such as the Severe Acute Respiratory Syndrome [SARS, in 2003] and Middle East Respiratory Syndrome [MERS, in 2015], which are known for calm starts but sudden outbreaks that spread very quickly,” catalyzed the company to move while there were no confirmed cases in South Korea. The company made an internal decision to develop the kit on Jan. 16, before the first seven cases were reported at the end of that month.

Kogene’s Lee also mentioned memories of the H1N1 influenza outbreak in 2009 as well as of MERS prompting the company to start development on its diagnostic kits on Jan. 10 once it obtained the genetic information posted by the Global Initiative on Sharing All Influenza data (GISAID). Development of the kits was completed 10 days later, after the WHO released the COVID-19 gene sequence and testing method, and the trial kits and documents were submitted to Korea Centers for Disease Control and Prevention (KCDC) on Jan. 29.

On Feb. 4, Kogene was “the first company to receive approval for EUAL in Korea, and this is the first case outside of China,” Lee added.

For Seegene, the project became a priority for both the company and the country after its initial decision of Feb. 16 to make a kit. The company started development of its kit just under a week later, on Jan. 21, and the documents were submitted to the Korean Ministry of Food and Drug Safety on Feb. 5, with the expedited approval received a week later on Feb. 12. The number of daily diagnosed cases started to rise a week later, on Feb. 19, and hit a high of 813 cases just ten days later.

The company has also delayed all projects for 2020 in order to be able to put all its available resources into developing and producing the kit, with Park unsure as to how long this delay will last. Their pipeline includes assays to test for tropical fever, genetics targets and human papilomavirus infections, according to its website.

Seegene’s test kit is currently the only domestic kit that can detect all three current COVID-19 E gene, RdRP gene, and N gene strains, and takes four hours to provide a result according to a Feb. 18 press release. Kogene’s offering detects the E gene and RdRP gene strain. Given the uncertain nature of the virus, Seegene is vigilantly checking for virus updates, such as mutations, on a daily basis and has designed the kit to be able to be altered for any mutations, according to Park.

The WHO reported 372,757 confirmed cases and 16,231 deaths globally as of March 24, which heightens the sense of urgency.

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