Seegene Collaborates with Thermo to Enter US Market

Food and Drug Administration (FDA) clearance of its Allplex diagnostic assay portfolio at the same time that Thermo Fisher files for FDA clearance to run Seegene's assays on Thermo Fisher's QuantStudio 5 Real-Time PCR System (PCR System).

Seegene develops high multiplex molecular diagnostic assays for the global market using its proprietary real-time PCR technologies. Seegene’s Allplex assay is capable of providing Ct values for multiple targets in a single tube or well and when combined with Thermo Fisher's PCR System, it will offer a comprehensive MDx solution. Seegene's portfolio of syndromic panel products, which includes various sexually transmitted infections, gastrointestinal, and respiratory pathogen detection assays, will be first introduced in the U.S. market. Thermo Fisher's dominant position in instrumentation will allow Seegene's multiplex detection technologies to establish a strong foothold in the U.S. market.

“The U.S. is the world's largest MDx market. Well versed in advanced detection technologies, it also has the strongest customer demands,” said Seegene's CEO, Dr. Jong-Yoon Chun. “The synergistic combination of Thermo Fisher's newest instrument and Seegene's powerful multiplex PCR chemistry technologies will enable us to gain U.S. market share by offering advanced detection methods to more physicians and patients.”

“We are proud to collaborate with Seegene as we move forward to seek FDA clearance for our respective platforms in parallel,” said Kim Kelderman, vice president and general manager of Genetic Analysis at Thermo Fisher Scientific. “We are committed to working with global partners who share our vision of driving better health outcomes.”