Seegene announces partnership with Bio-Rad to develop diagnostic testing products for the U.S. Market

Seegene announces partnership with Bio-Rad for the development and commercialization of infectious disease molecular diagnostic products

Diagnostic tests designed for the pandemic and the post-pandemic era with high multiplex technology

A significant step forward for Seegene in expanding its business to the U.S.,the world's biggest in vitro diagnostics market.

SEOUL,South Korea,July 6,2021 -- Seegene Inc. (KQ 096530),aSouth Korean leading biotechnology firmhas signed a partnership agreementwith American biotechnology companyBio-Rad Laboratories,Inc.tosupport entering theU.S.market.

Seegene announcedon July 1that it has signed a partnership with Bio-Rad,laboratories,Inc. for the clinical development and commercialization of infectious disease molecular diagnostic products. Under the terms of the agreement,Seegene will provide diagnostic tests for use on Bio-Rad's CFX96™ Dx Real-Time PCR System for the U.S. market,pending clinical development and approval from the U.S. Food & Drug Administration (FDA).

According to the 'Report on the U.S.In Vitro Diagnostics market Trend' released by theKorea Trade-Investment Promotion Agency (KOTRA) in 2020,North America isa veryimportant market,accounting for about 37 percent of the global in vitro diagnostic industry. However,it has been difficult for newer foreign companies to enter the U.S. market because the market has already been dominated by well-establishedglobal companies and the U.S. government prioritizes its domestic products.Under such circumstances,the supply deal with Bio-Rad,a biotech giant with over 60 years of history,is expected to be a significant step forward for Seegene in entering the U.S. market.

Founded in 1952,Bio-Rad is a global leader in the fields of life science and clinical diagnostics.The company has beenSeegene'smajor partnerover the past ten years. Previously,Seegenewas able togenerate some 1 trillion won worth of sales revenue by applying its diagnostic assays to Bio-Rad's PCR systems that had already been installed globally. This new partnership is expected to streamline the process for Seegeneto seek U.S.FDA clearance and the partnership of thetwoworldclasscompaniesis expected to drive new U.S. market opportunity.

Seegene plans to submit applications for FDA approval forits diagnosticreagentmade of the firm'shigh-multiplex diagnostic technology,which isunique in its capability to simultaneously screenmultiple target geneson a high throughput real time PCR system.UsingSeegene's proprietary technologies,itcanalsoselectively amplifytarget geneswhile identifyingdifferent viruses and the number of viruses. Thanks to the deal,Seegenewill partner with Bio-Rad to plan to seek U.S. FDA clearance and offer a wide range of its products to U.S. customers.

Under thedeal,Seegeneintends to seek U.S.FDA clearance for clinical assays on Bio-Rad's real-time PCR system'CFX96 (TM)DxReal-Time PCR System'.

This includes an intent to clear Seegene's'AllplexTMSARS-CoV-2/FluA/FluB/RSV Assay',a multiplex real-time PCR assay.Going forward,the company says it is also planning to establish research and manufacturing facilities in the United States.This deal provides the potential access for Seegene toenter the U.S. market with items selected among over 150 diagnostic assays already sold globally.

TheAllplexTMSARS-CoV-2/FluA/FluB/RSV Assaycan simultaneously detectand differentiate a total offive viruses including Flu A,Flu B,RSV A/B and three target genes of COVID-19 (N gene,S geneandRdRPgene)in a single test. Itis also suitable for mass testing and capable of targeting more genes thanitscompetitors' products. It is also expected to play a critical role in a new pandemic situation bydetecting various respiratory diseasesas well as genetic variantswhich mayresurgein the U.S.when the country eases prevention guidelinesfollowingthe nationwide vaccination.

Ho Yi,Chief Sales and Marketing Officer of Seegene said,"To expand our business in the U.S. market,itis important to work closely witha globalcompanylike Bio-Radthat has comprehensive network in the region.Together withSeegene'sadvancedtechnologyand Bio-Rad'ssolid client base,the two will be able totake the lead in theU.S. market." He added that"The dealis expected toserve asthe steppingstoneforSeegeneto secure its foothold in the U.S.market.And it will also help increase the company's revenue and expand the business into other countries going forward."