Multiplex PCR technologies provider Seegene has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its TOCE-based herpes simplex virus (HSV) type I and type II assays.
Based on MuDT technology, Allplex tests help in simultaneous detection and quantification of multiple targets in a single fluorescence channel, without melting curve analysis.
Seegene founder, CTO and CEO Dr Jong-Yoon Chun said: "This is an important milestone in support of our planned entry into the United States, the largest molecular diagnostic market in the world.
"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."
The firms CE-marked Allplex Respiratory Panel 1 (Flu / RSV / FluA subtyping) simultaneously identify and quantify seven targets, comprising Influenza virus A and B, RSV type A and B, and Influenza A virus subtypes (H1, H3, and H1pdm09).
The company plans to create a new US subsidiary in 2015, in a bid to expand its global molecular diagnostic market.