FDA Grant Breakthrough Designation for ResistancePlus^® GC

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Designation for ResistancePlus^® GC – expediting the path towards clearance. This is the first commercially available molecular test that can guide treatment decisions for gonorrhea infections, giving doctors and patients the option of using a simple oral dose of ciprofloxacin instead of ceftriaxone injection, one of the last remaining antibiotics available for multi-drug resistant infections.

“There is an urgent need for better diagnostics to address the problem of drug-resistant gonorrhea in the United States,” said Dr. Jeffrey Klausner, Professor of Medicine and Public Health at David Geffen School of Medicine and Fielding School of Public Health, University of California, Los Angeles. “Drug-resistant gonorrhea is an urgent public health problem.”

Read the full press release.