Seegene announced it has entered into a new strategic collaboration relationship with Thermo Fisher Scientific in which Seegene will file for U.S 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.
Seegene is a developer of high multiplex molecular diagnostic assays for the global market using its proprietary real-time PCR technologies. The Allplex assay is innovative in its capability to provide Ct values for multiple targets in a single tube or well.
A collection of sexually transmitted infection, gastrointestinal, and respiratory pathogen detection assays will be introduced to the U.S. market first. Because different pathogens often cause patients to present with similar clinical symptoms but often require different medical treatments, the need for accurate diagnosis is driving strong demand for syndromic panels that allow precise testing. Seegene's Allplex diagnostic products have been proven to address such market demand as shown by its rapid growth in the European market. Seegene aims to submit for 510(k) clearance by the end of 2018.
"The U.S. is the world's largest MDx market. Well versed in advanced detection technologies, it also has the strongest customer demands,” Seegene's CEO, Dr. Jong-Yoon Chun said. “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," Kim Kelderman, vice president and general manager of Genetic Analysis at Thermo Fisher Scientific said. "We are committed to working with global partners who share our vision of driving better health outcomes."