Product News: SpeeDx Receives CE-IVD Mark for ResistancePlus GC

New molecular assay enables rapid antibiotic resistance result to support use of cost effective and convenient oral antibiotic for gonorrhea treatment

06 Dec 2018


SpeeDx Pty. Ltd. has announced it has received CE-IVD marking for its ResistancePlus® GC assay that detects both the sexually transmitted infection (STI) N. gonorrhoeae (GC) and sequences in the gyrA gene of the bacteria associated with susceptibility to ciprofloxacin, a previously used front-line antibiotic treatment.

"As a clinician, I would like to treat as many GC infections with ciprofloxacin as possible,” said Dr. John White, Sexual Health Physician in the UK and Editor-in-Chief of the International Journal of STDs & AIDS

“Single-dose ciprofloxacin is cheaper, quicker and easier for both patients and staff and it’s an excellent drug for treating GC, including pharyngeal infections. 

“We are fortunate here in Europe that most gonococcal infections could potentially be treated with this drug if we had access to accurate and timely resistance information such as is available with the ResistancePlus GC assay.”

In response to the clear utility of ciprofloxacin, the British Association of Sexual Health and HIV (BASHH) have recently drafted new gonorrhea management guidelines that include the preferential use of ciprofloxacin over ceftriaxone if antimicrobial susceptibility results are available prior to treatment.

Ceftriaxone, a painful intramuscular injection, is the current front-line treatment for gonorrhea and represents one of the last remaining antibiotics for multi-drug resistant infections.

“If we can use less ceftriaxone this may help to stall the further development and dissemination of ceftriaxone-resistant strains within Europe," comments Dr. White.

ResistancePlus GC is the first commercially available molecular test* providing ciprofloxacin susceptibility information and is well placed to support current laboratory molecular testing workflows.

"It’s great to see novel molecular diagnostics moving beyond just a positive/negative capability - providing results that help manage patients more effectively by enabling tailored treatment," adds Dr. White.

*available where CE-mark is accepted, not available in the U.S. or A.U.