Antibiotic resistance test for gonorrhea gets FDA breakthrough nod

FDA granted a breakthrough designation to Australia-based SpeeDx to expedite the path to U.S. clearance for a molecular test that detects both N. gonorrhea and a patient’s susceptibility or resistance to the antibiotic ciprofloxacin.

Results from the ResistancePlus GC test can be used to determine whether patients can be treated with ciprofloxacin rather than ceftriaxone, the current front-line treatment for gonorrhea.

There have been reports in the United Kingdom and Australia of resistance to ceftriaxone, an antibiotic used to treat many kinds of bacterial infections, including organisms that are resistant to other antibiotics.