Seegene Inc. has signed a partnership agreement with American biotechnology company Bio-Rad Laboratories, Inc. to support entering the U.S. market. 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). Seegene plans to submit applications for FDA approval for its diagnostic reagent made of the firm's high-multiplex diagnostic technology, which is unique in its 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. Thanks to the deal, Seegene will 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 the deal, Seegene intends to seek U.S. FDA clearance for clinical assays on Bio-Rad's real-time PCR system 'CFX96 (TM) Dx Real-Time PCR System'.

This includes an intent to clear Seegene's 'AllplexTM 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 AllplexTM 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 its competitors' 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.