FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Seegene Gets FDA Green Light for Herpes Virus Assay

Feb. 19, 2015

Seegene, a Seoul, Korea-based developer of multiplex polymerase chain reaction technologies, said Monday that it received FDA clearance for its Toce technology-based herpes simplex virus types 1 and 2 assay. This is Seegene’s first product to go through the FDA’s process, and paves the way for other planned submissions of PCR reagents, the company added.

The Toce technology enables confirmation of five or more genetic variations and can perform qualitative tests of multiple clinical samples, according to the devicemaker. "This is an important milestone in support of our planned entry into the United States, the largest molecular diagnostic market in the world," said CEO Jong-Yoon Chun, Founder.

Seegene said it plans to establish a U.S. subsidiary in 2015 to speed its growth in the global molecular diagnostics market. The company will also continue to build and expand its Allplex line of infectious disease panel tests for the U.S. market. Those tests, based on Seegene’s multiple detection temperatures, of MuDT, technology, are the most comprehensive and cost-effective multiplexed PCR molecular assays of infectious disease in the industry, the firm claims. — Kellen Owings