Seegene has joined with Thermo Fisher Scientific to bring its diagnostic assays to market in the U.S. The agreement will see the South Korean molecular diagnostics player file for FDA clearance for its Allplex assay portfolio at the same time as Thermo Fisher seeks a regulatory nod to run the diagnostics on its equipment.
Thermo Fisher’s filing will cover the use of Seegene’s assays on its QuantStudio 5 PCR system. If the FDA signs off on Seegene’s Allplex assays and their use on QuantStudio, the South Korean company will enter the U.S. with the tailwind of having access to Thermo Fisher's user base. Seegene CEO Jong-Yoon Chun, Ph.D., sees the alliance boosting his company’s chances of cracking a key market.
“The U.S. is the world's largest [molecular diagnostics] market,” Chun said in a statement. “Well versed in advanced detection technologies, it also has the strongest customer demands. 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.”
Chun plans to build his pitch for the U.S. market on Allplex, a portfolio of panel assays. Each panel is designed to detect pathogens that affect certain parts of the body using reverse transcription PCR. The gastrointestinal panel, for example, enables users to detect six viruses, six parasites and 13 bacteria that can infect the gastrointestinal tract. Seegene picked up a CE mark for the gastrointestinal panel two years ago to clear it to sell the assay in Europe.
That marked the start of a period of growth in the region. In the third quarter, Seegene reported that revenues in Europe were up 32% year on year, growth that resulted in the region accounting for almost half of its sales. The growing significance of Europe to Seegene is happening in parallel to the rise of Allplex. Having accounted for 1% of sales in the first half of 2015, the assay portfolio is now generating more than one-third of Seegene’s revenues.
It will be 18 months or so before Seegene finds out whether it can repeat the success in the U.S. Seegene plans to file for 510(k) clearance by the end of next year. The plan is to start the attempt to break into the U.S. by introducing assays for detecting sexually transmitted infections and pathogens affecting the gastrointestinal and respiratory systems.