The ResistancePlus GC test from SpeeDx for detecting Neisseria gonorrhoeae bacteria has received breakthrough device designation from the U.S. Food and Drug Administration (FDA), the company announced on June 11.
ResistancePlus GC uses real-time quantitative polymerase chain reaction (qPCR) technology to test for gonorrhea and is already cleared for use in Europe, Australia, and Canada. The test detects the presence of N. gonorrhoeae bacteria, as well as sequences in the gyrA gene of the bacteria that could be a sign of an individual's susceptibility or resistance to treatment with the oral antibiotic ciprofloxacin.
Ciprofloxacin is an alternative to intramuscular injection of the antibiotic ceftriaxone, which is used as a front-line treatment for gonorrhea but has also been associated with treatment resistance.
SpeeDx also noted that it is positioning another test for the U.S. market: ResistancePlus MG for detecting the sexually transmitted infection Mycoplasma genitalium (Mgen) and analyzing markers of antibiotic resistance. The FDA cleared the first test for detecting this bacterium -- Hologic's Aptima M. genitalium assay -- in January.
