The Food and Drug Administration (FDA) has granted Breakthrough Device designation to ResistancePlus GC (SpeeDx), a test that detects ciprofloxacin susceptibility and provides resistance information to aid in the treatment of gonorrhea.
According to the Centers for Disease Control and Prevention (CDC), antibiotic-resistant gonorrhea continues to be a significant public health threat. Currently, guidelines recommend dual therapy with ceftriaxone administered intramuscularly and oral azithromycin, however the emergence of cephalosporin-resistant gonorrhea may significantly complicate the ability for clinicians to treat the infection successfully. “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.
Due to the emergence of fluoroquinolone-resistant Neisseria gonorrhoeae in the US, the CDC ceased recommending fluoroquinolones for treatment of gonorrhea. Results from the ResistancePlus GC test, which detects both N. gonorrhoeae and sequences in the gyrA gene of the bacteria associated with susceptibility or resistance to ciprofloxacin, could potentially save patients from more invasive treatment if their infections are found to be susceptible to ciprofloxacin.
“We are very pleased that the FDA has recognized ResistancePlus GC as an important tool for the ongoing arms race against gonorrhea and rising antibiotic resistance,” said Colin Denver, SpeeDx CEO. “The results from our tests empower clinicians to make better informed treatment decisions, and we are passionate about the responsible use and stewardship of antibiotics to achieve the best possible patient outcomes.”
For more information visit plexpcr.com.