Seegene Inc has received FDA 510(k) market clearance for its TOCE™- based herpes simplex virus (HSV) types 1 and 2 assay. This is the first product that Seegene has taken through the FDA, and it opens the way for Seegene’s other planned FDA submissions of multiplex real-time PCR reagents.

“This is an important milestone in support of our planned entry into the United States, the largest molecular diagnostic market in the world,” said Dr. Jong-Yoon Chun, founder, CTO and CEO of Seegene. The company aims to establish a new U.S. subsidiary in 2015 and seeks to further accelerate its growth in the rapidly evolving global molecular diagnostic market. Seegene will also continue to evolve its Allplex family of infectious disease panel tests for the U.S. market.

Allplex tests are based on its breakthrough MuDT™ technology that allows simultaneous detection and quantification of multiple targets in a single fluorescence channel, without melting curve analysis. Allplex tests are the most comprehensive and cost-effective multiplexed PCR molecular assays for infectious disease in the industry.

For example, Seegene’s CE-marked Allplex Respiratory Panel 1(Flu / RSV / FluA subtyping) simultaneously identify and quantify seven targets, including Influenza virus A and B, RSV type A and B, and Influenza A virus subtypes(H1, H3, and H1pdm09), making them the world’s first and only high-multiplexed respiratory panels based on real-time PCR platform.