Seegene Announces Partnership with Bio-Rad to Develop Diagnostic Test Products for the U.S. Market

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  • Seegene announces partnership with Bio-Rad for the development and commercialization of molecular diagnostic products for infectious diseases
  • Diagnostic tests designed for the pandemic and the post-pandemic era with a high multiplex technology
  • A significant step forward for Seegene in expanding its business in the United States, the largest in vitro diagnosis market.

Seoul, South Korea, July 6, 2021 / PRNewswire / – Seegene Inc. (KQ 096530), a Korean a leading biotechnology company signed a partnership agreement with the US biotechnology company Bio-Rad Laboratories, Inc. to support entering on American market.

Seegene announced on 1st of July this he signed a partnership with Bio-Rad, Laboratories, Inc. for the clinical development and commercialization of molecular diagnostic products for infectious diseases. 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 American market, awaiting clinical development and US Food & Drug Administration (FDA) approval.

According to the “United States In Vitro Diagnostics Market Trend Report” released by the Korea Business Investment Promotion Agency (KOTRA) in 2020, North America is a very important market, accounting for around 37 percent of the world market in vitro diagnostic industry. However, it was difficult for more recent foreign companies to enter the US market because the market has already been dominated by well-established global companies and the US government prioritizes its domestic products. Under such circumstances, the supply agreement with Bio-Rad, a biotech giant with more than 60 years of history, should be a significant step forward for Seegene in its entry into the US market.

Founded in 1952, Bio-Rad is a world leader in the fields of life sciences and clinical diagnostics. The company has been Seegene’s major partner for the past ten years. Previously, Seegene was able to generate 1,000 billion won sales value by applying its diagnostic tests to Bio-Rad’s PCR systems which had already been installed at the World level. This new partnership is expected to streamline Seegene’s process for researching we FDA clearance and the partnership of the two world-class companies are expected to generate new market opportunities in the United States.

Seegene plans to submit FDA approval requests for his diagnostic reagent composed of the company’s high multiplexing diagnostic Technology, which is unique in its ability to screen multiple target genes simultaneously 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. Through this agreement, Seegene will partner with Bio-Rad to seek US FDA clearance and offer a wide range of its products to its US customers.

As part of the deal, Seegene intends to seek US FDA clearance for clinical trials on Bio-Real-time PCR system of Rad ‘CFX96 (MT) Real-time PCR Dx System’.

This includes an intention to clear the Seegene AllplexMT SARS-CoV-2 / FluA / FluB / RSV Assay ‘, a real-time multiplex PCR assay. Going forward, the company said it plans to establish research and manufacturing facilities in the United States as well. This agreement provides Seegene with potential access to enter the USA. market with items selected from more than 150 diagnostic tests already sold worldwide.

The AllplexMT The SARS-CoV-2 / FluA / FluB / RSV test can simultaneously detect and differentiate a total of five viruses including influenza A, influenza B, RSV A / B and three COVID-19 target genes (N gene, gene S and RdRP gene) in one test. It is also suitable for mass testing and capable of targeting more genes than the products of its competitors. It is also expected to play a pivotal role in a new pandemic situation by detecting various respiratory diseases as well as genetic variants that could reappear in the United States when the country relaxes prevention guidelines following nationwide vaccination.

Ho Yi, Sales and Marketing Director of Seegene mentionned, “To expand our business in the US market, it is important to work closely with a global company like Bio-Rad which has a full network in the region. With Seegene’s advanced technology and Bio-Rad’s strong customer base, both will be able to take the lead in the US market. He added that “the deal should serve as a springboard for Seegene to secure its presence in the US market. And it will also help increase the company’s revenue and expand its operations in other countries to the to come up.”

SOURCE Seegene Inc.


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