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SpeeDx Gets CE-IVD Mark for Antibiotic-Resistant Gonorrhea MDx

NEW YORK (GenomeWeb) – Australian diagnostics firm SpeeDx announced on Thursday that it has received CE-IVD marking for a qPCR assay to detect both Neisseria gonorrhoeae and sequences in the gyrA gene of the bacteria linked to ciprofloxacin susceptibility.

According to SpeeDx, the Resistance GC assay will allow doctors to confidently and cost-effectively treat up to 70 percent of gonorrhea infections with a single oral dose of ciprofloxacin.

"If more doctors use the ResistancePlus GC assay, patients will have a better choice when it comes to treatment and we might make a big difference in controlling antibiotic resistance gonorrhea," Jeffrey Klausner, a professor of medicine and public health at the University of California, Los Angeles, said in a statement.

In addition to its ResistancePlus GC assay, SpeeDx also offers its CE-marked ResistancePlus MG assay, which the firm aims to receive 510(k) approval from the US Food and Drug Administration in 2019. In November, SpeeDx previously signed four distribution deals to increase its reach in European countries.