Seegene Gets FDA Clearance for Herpes MDx Test | GenomeWeb

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.

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