New diagnostic test enables antibiotic resistance testing and stewardship in gonorrhea treatment

June 12, 2019

In a press release, SpeeDx announced the FDA has granted Breakthrough Device designation for ResistancePlus GC—expediting the path toward FDA clearance. ResistancePlus GC is a commercially available molecular test providing ciprofloxacin susceptibility and resistance information to effectively treat the sexually transmitted infection (STI) N. gonorrhea. It is already CE-marked and cleared by the Therapeutic Goods Association (TGA) for use across Europe, Australia, and New Zealand. It detects both the sexually transmitted infection N. gonorrhea and sequences in the gyrA gene of the bacteria associated with susceptibility or resistance to ciprofloxacin, a previously used front-line antibiotic treatment.

Results from the test can be used to guide treatment decisions for gonorrhea infections, giving doctors and patients the option of using ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant infections.

The FDA Breakthrough Devices Program is intended to help patients have more timely access to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases by expediting their development, assessment, and review.

Ceftriaxone, a painful intramuscular injection, is the current front-line treatment for gonorrhea, however resistance has already been reported in Europe and Australia and experts are concerned that we may quickly run out of treatment options altogether. Recent surveillance data indicates that in some regions up to seven out of 10 infections could be effectively treated with a single, more convenient oral dose of ciprofloxacin if the susceptibility status is established prior to prescribing. The British Association of Sexual Health and HIV (BASHH) have recognized the importance of antibiotic stewardship in their recently updated gonorrhea management guidelines, preferring the use of ciprofloxacin over ceftriaxone if antibiotic susceptibility results are available prior to treatment.

Visit SpeeDX for the release