Seegene announced on July 1 that 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 the Korea Trade-Investment Promotion Agency (KOTRA) in 2020, North America is a very important market, accounting for about 37% 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-established global 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 has been Seegene’s major partner over the past 10 years. Previously, Seegene was able to generate 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 Seegene to seek U.S. FDA clearance and the partnership of the two world class companies is expected to drive new U.S. market opportunity.

Anatomy of a Partnership

Seegene plans to submit applications for FDA approval for its diagnostic reagent made of the firm’s high-multiplex diagnostic technology, which has the capability to simultaneously screen multiple target genes on a high throughput real time PCR system. Using Seegene’s proprietary technologies, it can also selectively amplify target genes while identifying different viruses and the number of viruses.

Under the deal, Seegene intends to seek U.S. FDA clearance for clinical assays on Bio-Rad’s real-time PCR system CFX96  Dx Real-Time PCR System.

This includes an intent to clear Seegene’s Allplex SARS-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 to enter the U.S. market with items selected among over 150 diagnostic assays already sold globally.

The Allplex SARS-CoV-2/FluA/FluB/RSV Assay can simultaneously detect and differentiate a total of five viruses including Flu A, Flu B, RSV A/B and three target genes of COVID-19 (N gene, S gene and RdRP gene) in a single test. It is also suitable for mass testing and capable of targeting more genes than similar products. It is also expected to play a critical role in a new pandemic situation by detecting various respiratory diseases as well as genetic variants which may resurge in the U.S. when the country eases prevention guidelines following the nationwide vaccination.

Ho Yi, Chief Sales and Marketing Officer of Seegene says, “To expand our business in the U.S. market, it is important to work closely with a global company like Bio-Rad that has comprehensive network in the region. Together with Seegene’s advanced technology and Bio-Rad’s solid client base, the two will be able to take the lead in the U.S. market. The deal is expected to serve as the stepping stone for Seegene to secure its foothold in the And it will also help increase the company’s revenue and expand the business into other countries going forward.”