NEW YORK (GenomeWeb) – Seegene today said that the US Food and Drug Administration has cleared for marketing the firm's herpes simplex virus 1 and 2 assay.
The test uses the company's TOCE primer technology (tagging oligonucleotide capture and extension) for multiplexed real-time PCR. It is the first product that Seoul, South Korea-based Seegene has taken through the FDA.
The firm submitted the HSV I & II test to the FDA for use on the Cepheid SmartCycler.
Seegene Founder and CEO Jong-Yoon Chun said in a statement that the 510(k) clearance "is an important milestone in support of our planned entry into the United States."
Though the firm also has offices in Gaithersburg, Md., it said today that it intends to establish a new US subsidiary this year to further accelerate its growth in the US as it further develops its Allplex family of infectious disease panel tests.
Chun told GenomeWeb last year that Seegene also has developed a 26-target respiratory pathogen panel using both TOCE and MuDT — a new data analysis method from the company that essentially doubles the number of analytes that can be detected with standard real-time PCR instruments — and hopes to submit that test for FDA clearance in 2015.