07 July 2021 | News
For the development and commercialization of infectious disease molecular diagnostic products
image credit- shutterstock
Seegene Inc., a South Korean leading biotechnology firm, has signed a partnership agreement with American biotechnology company Bio-Rad Laboratories, Inc. to support entering the US market.
Seegene announced on July 1 that it has signed a partnership with Bio-Rad 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 US market, pending clinical development and approval from the U.S. Food & Drug Administration (FDA).
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 (US). This deal provides the potential access for Seegene to enter the US market with items selected among over 150 diagnostic assays already sold globally.
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 percent of the global in vitro diagnostic industry.