Seegene Accelerates US Market Entry... Signs FDA Approval and Distribution Agreement with Bio-Rad

Seegene Molecular Diagnostic Reagents to be Integrated into Bio-Rad Diagnostic Devices for FDA Approval Pursuit

[Asia Economy Reporter Kim Ji-hee] Seegene is making a full-scale entry into the U.S. market by partnering with global bio-diagnostic equipment company Bio-Rad.

On the 1st, Seegene announced that it has signed a joint FDA approval and distribution agreement with U.S.-based Bio-Rad for molecular diagnostic reagents and equipment. Accordingly, the two companies have begun the process of obtaining FDA approval by integrating Seegene's molecular diagnostic reagents into Bio-Rad's diagnostic devices. The contract period is five years from the date of FDA approval.

Founded in 1952, Bio-Rad possesses world-class technology in the molecular diagnostic equipment field, in addition to its sales network within the U.S. It is also a key partner of Seegene, with whom it has built a partnership over the past decade. Seegene has applied its diagnostic reagents to approximately 3,900 Bio-Rad diagnostic devices installed worldwide, generating annual sales exceeding 1 trillion KRW. Since FDA approval can be pursued immediately without a separate product development process for entering the U.S. market, it is expected that the approval schedule can also be shortened.

The multiplex diagnostic technology applied to the diagnostic reagents for which Seegene is pursuing FDA approval is a technology capable of simultaneously detecting multiple target pathogens in high-throughput testing systems. It includes Seegene's patented technologies such as selectively amplifying multiple target pathogens simultaneously and quantifying both the type and amount of pathogens, which is expected to provide competitiveness in the U.S. market. Until now, Seegene's syndromic-based multiplex technology had not been introduced locally due to equipment licensing issues.

Initially, Seegene plans to obtain FDA approval for eight strategic products, including the simultaneous COVID-19 diagnostic kit 'Allplex™ SARS-CoV-2·FluA·FluB·RSV Assay,' for use with Bio-Rad's molecular diagnostic equipment. This product is a multiplex diagnostic kit capable of testing for five viruses?including the COVID-19 virus and influenza viruses A and B?in a single test. Seegene also plans to establish local production and research facilities in the U.S., aiming to obtain FDA approval for more than five products annually in the future.

Lee Ho, Seegene's Chief Sales Officer, said, "Combining Seegene's unique diagnostic technology with Bio-Rad's equipment and extensive network will greatly help us gain an advantage in the U.S. market," adding, "Following recent consecutive orders in European markets such as Italy and Scotland, this contract marks a significant turning point for our entry into the U.S. market."

This content was produced with the assistance of AI translation services.