HONG KONG – Seegene Inc. has developed a COVID-19 test kit that is able to both detect and identify multiple mutant variations of the virus.

“Getting test results from the Allplex SARS-CoV-2 Variants Ⅰ Assay takes two hours, which is normally how long getting results from a PCR test takes,” a Seegene spokesperson told BioWorld.

COVID-19 variants that the test kit can identify include B 1.1.7, first detected in the U.K. in September 2020, the 501Y.V2 variant detected in South Africa in October 2020, and the P.1 variant detected in Brazil in January 2021.

The New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), an expert committee of the U.K.’s Department of Health and Social Care, said that the B 1.1.7 strain has “substantially increased transmissibility compared to other variants.” The strain has already been discovered in 70 countries, according to the World Health Organization.

The test kit uses at least 10 of Seoul, South Korea-based Seegene’s technologies, one of which is a multiplex real-time PCR method called mTOCE. The mTOCE technology detects the specific spot where the mutation occurs, in turn enabling the precise detection and differentiation of the virus using a single tube of reagent.

The technology is also able pre-screen potential new variants, the company said.

Another key feature of the technology is an endogenous internal control that can verify the entire testing process inclusive of proper sample collection. Seegene’s big data auto-surveillance in silico system enables close monitoring and analysis of a worldwide database on COVID-19 and its variants, allowing the company to quickly respond with product development.

Unlike the currently available individual sample sequencing method used to detect the variant, the technology enables massive testing. The new test kit will boost mass testing ability in the fight against the global spread of the mutant COVID-19 variants, where time is of the essence, said a Seegene official.

With the variants said to spread more easily and quicker than the original virus, the company is working with governments and organizations globally to receive approvals for the test kit. The company did not provide further details, however.

Allplex SARS-CoV-2 Variants Ⅰ Assay is not the only COVID-19 test kit that Seegene has developed. Its Allplex 2019-nCOV Assay received urgent-use approval from Korea’s Ministry of Food and Drug Safety (MFDS) in February 2020.

Other companies that received MDFS approvals for their test kits around the same time include Kogene Biotech Co. Ltd., Sd Biosensor Inc. and Solgent Co.

Seegene won emergency use authorization from the FDA for the test kit in April 2020. The only detection kit able to detect the E, RdRP and N target genes at the time, the kit can perform 1,000 tests simultaneously and deliver the diagnosis in less than four hours.

Seegene made the initial decision to develop a test kit on Feb. 16, 2020. Work started just under a week later, and the company submitted documents to MFDS on Feb. 5. All other projects for 2020 were delayed in order to prioritize the test kit.

Testing has been a key weapon in South Korea’s fight against COVID-19, with government data showing more than 5.7 million tests performed and over 5.6 million of those concluded as of Feb. 3. There are 79,311 cases in the country as of Feb. 3, according to Johns Hopkins University data.

Seegene is also looking overseas and is expanding its operations in Latin America. Brazil’s Anvisa approved its Allplex SARS-CoV-2/FluA/FluB/RSV Assay, a syndromic test that can detect multiple target genes including COVID-19, influenza and common cold, in January.

The number of test kits earmarked for export to Brazil was not disclosed. Seegene also has subsidiary offices in Brazil and Mexico, and is also working with clients and vendors in Peru, Ecuador, Venezuela and Argentina. Multiple partnerships are currently in the works.

“Seegene’s Allplex SARS-CoV-2/FluA/FluB/RSV Assay won the fiercely competitive bidding process in Peru this year, enabling some 24 regions to proceed with the coronavirus/flu coinfection research project,” said the company. Seegene is partnering with Ecuador’s Simed to distribute the test kits in Peru.

Meanwhile, the company donated 20,000 Allplex SARS-CoV-2 Assay test kits to the Ecuadorian government in December 2020. The test kits will be distributed to National Institute for Public Health Research in the cities of Quito and Cuenca, and to the Quito city government.

The global expansion has contributed to the company’s revenue. Aggregated sales surpassed the ₩1 trillion (US$900 million) mark in 2020, up nearly 10 times its previous annual sales of ₩120 billion in 2019. Seegene also plans to raise its annual production capacity to ₩5 trillion from the current ₩2 trillion by the first quarter of 2021, the company said.