Genematrix announced Thursday that it has acquired the Conformite Europeenne Mark-In Vitro Diagnostic (CE-IVD) certification for Neoplex STI-14 kit, a new multimolecular diagnostic device that detects 14 sexually transmitted pathogens.
“There are about 357 million new cases of sexually transmitted infections (STI) annually, with a high annual growth rate of 8.3 percent,” the company said. “There is a high demand for a kit that can conduct multiple diagnoses both locally and internationally due to the high rate of overlapping infections and the necessity of customized therapy for each causative organism.”
The device uses the company’s own “C-Tag” technology, which is a multi-analysis source based on the real-time polymerase chain reaction, can simultaneously diagnosis STI-14 pathogens, including chlamydia, gonorrhea, non-gonococcal urethritis, syphilis, vaginitis.
“The acquisition of CE-IVD certification for the company’s kit demonstrates that it meets European standards for performance and quality,” Genematrix CEO Kim Soo-ok said. “We will continue to sharpen our competitiveness in the European market with differentiated performance encouraged by the certification.”
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