Seegene to seek FDA approval for diagnostics with US firm

By Baek Byung-yeul

Seegene is tapping into the in-vitro diagnostics market in the United States by forging a partnership with Bio-Rad Laboratories, a U.S.-based developer of clinical diagnostic products, the company said Thursday.

The Korean biotech company said the two firms agreed to pursue joint business projects and cooperate in obtaining authorization from the U.S. Food and Drug Administration (FDA) to sell molecular diagnostics products for infectious diseases.

The company added that the term of the contract is five years from the date of receiving FDA approval of the deal.

Seegene expects the partnership to help improve its business as the U.S. is home to the largest diagnostics market in the world.

According to 2020 data by the Korea Trade-Investment Promotion Agency (KOTRA), the U.S. accounted for the largest share of around 37 percent of the global in-vitro diagnostics market.

However, foreign firms have struggled to advance into the U.S. market due to the country's prioritization of local companies, which has posed obstacles for foreign firms to obtain authorizations from the U.S. drug administration.

Seegene plans to win FDA approval for seven products, including a COVID-19 testing kit. It also envisions establishing a production and research facility in the U.S.

The company said it has worked closely with Bio-Rad for the past 10 years as the U.S. firm, established in 1952, has a solid sales network in the U.S. and secured industry-leading technology in molecular diagnostics equipment.

Dara Wright, executive vice president at Bio-Rad, said the company looks forward to working with Seegene to provide necessary diagnostic testing products to the U.S. market.

“Seegene's unique assay design, chemistries, and high-level multiplexing can detect multiple infectious disease targets simultaneously, making the assays well-suited for syndromic testing,” she said.

“Following a series of recent contracts in Europe, including Italy and Scotland, this partnership is a turning point for us to advance into the U.S. market,” Lee Ho, president and chief of sales at Seegene, said. “Expanding into the U.S. market will be a great stepping stone for stable growth of the company.”

Seegene became one of the world's leading diagnostics firms with its COVID-19 testing kits in 2020. The company rolled out the testing kits just three weeks after development began by using advanced technology to quickly analyze a vast amount of virus data and the classifications of patients.