FDA grants 510(k) clearance for Seegene’s HSV molecular test

The US Food and Drug Administration (FDA) has granted 510(k) market clearance for South Korean developer of multiplex PCR technologies, Seegene's TOCE-based herpes simplex virus (HSV) types 1 and 2 assay.

According to the company, TOCE-based HSV assay is the first product that was taken through the FDA, and it opens the way for other planned FDA submissions of multiplex real-time PCR reagents.

The company is planning to establish a new US subsidiary this year, and seeks to speed-up its growth in the global molecular diagnostic market.

Seegene founder 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 commercialise 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."

The company will also continue to evolve its Allplex family of infectious disease panel tests for the US market.

Allplex tests are based on the company's MuDT technology that enables simultaneous detection and quantification of multiple targets in a single fluorescence channel, without melting curve analysis.

The company is focused on developing multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx).

M-MoDx tests, which are based on the company's ACP, DPO, READ, TOCE, mTOCE and MuDT technologies, can simultaneously detect multiple targets with high-sensitivity, specificity and reproducibility.