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Seegene Receives FDA Clearance for its Herpes Simplex Virus Molecular Test

Gaithersburg, Maryland and SEOUL, Korea, February 17, 2015 – Seegene Inc. (096530.KQ), a leading developer of multiplex PCR technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 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. “After more than 10 years of extensive efforts to continually develop and commercialize novel technologies to surpass the capabilities of real-time PCR, we successfully invented MuDT™ technology, an ultimate multiplex real-time PCR technology that marks a new era in the molecular diagnostics industry. Through the US FDA approval, Seegene now intends to actively enhance its leadership in the multiplex real-time PCR diagnostic testing market.”

According to 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.

About Seegene

Seegene is the world’s leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx). Seegene’s core enabling technologies – ACP™, DPO™, READ™, TOCE™, mTOCE™ and MuDT™ – are the foundation for M-MoDx tests that can simultaneously detect multiple targets with high sensitivity, specificity and reproducibility.  Seegene’s products detect multi-pathogens with great reliability and throughput, ultimately providing the most economical basis for saving time, labor and cost. Seegene’s mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenomics, and oncology using innovative proprietary technologies.

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