Seegene, a South Korea's leading biotech firm, signed a partnership agreement with US biotech company Bio-Rad Laboratories, Inc to support entry into the United States market.

Seegene announced on June 1 the signing of an agreement with Bio-Rad Laboratories, Inc. to develop and commercialize products for molecular diagnostics of infectious diseases. Under the terms of the agreement, Seegene will provide diagnostic tests for use in Bio-Rad's CFX96 Dx Real-Time PCR System for the United States market. These will be subject to clinical development and approval by the Food and Drug Administration of that country (FDA).

According to the “United States in Vitro Diagnostics Market Trend Report” released by the Korea Trade and 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 US market as the US market is dominated by established global companies and the US government prioritizes domestic products. In such circumstances, the supply agreement with Bio-Rad, a biotech giant with more than 60 years of history, is expected to be an important step for Seegene to enter the United States market.

Seegene plans to apply for FDA approval for its diagnostic reagents developed with the firm's multiplex technology, which is unique in its ability to simultaneously detect multiple target genes in a high-throughput real-time PCR system. Using Seegene's proprietary technologies, it is also possible to selectively amplify target genes while identifying and quantifying different viruses. Through this agreement, Seegene will partner with Bio-Rad with plans to pursue FDA approval in the United States and offer a wide range of its products to customers in that country.

In light of the agreement, Seegene intends to seek clearance from the United States FDA for clinical trials on Bio-Rad's "CFX96 (TM) Dx Real Time PCR System,

This includes the intent to gain approval for Seegene's “Allplex SARS-CoV-2/FluA/FluB/RSV Test”, a real-time multiplex PCR test. Going forward, the company says it also plans to create research and manufacturing facilities in the United States. This agreement provides Seegene's potential access to enter the United States market with items selected from more than 150 diagnostic assays that have already been sold globally.