13 June 2019 - - The US Food and Drug Administration has granted Breakthrough Device designation for ResistancePlus GC - expediting the path towards FDA clearance, Australia-based SpeeDx Pty. Ltd. Said.
ResistancePlus GC is the first commercially available molecular test providing ciprofloxacin susceptibility and resistance information to effectively treat the sexually transmitted infection N. gonorrhea.
It is already CE-marked and cleared by the Therapeutic Goods Association 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 recognised 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.
Besides developing antibiotic resistance testing for gonorrhea, SpeeDx is also conducting multi-site clinical trials for the ResistancePlus MG test (not currently available for sale in the US).
The molecular test detects the rapidly rising STI Mycoplasma genitalium, also known as Mgen, along with genetic markers linked to antibiotic resistance.
In recent years, Mgen prevalence has increased globally and developed high rates of resistance to the frontline antibiotic treatment, azithromycin.
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe.
SpeeDx specialises in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management.
Innovative real-time polymerase chain reaction technology has driven market-leading multiplex detection and priming strategies.
Product portfolios focus on multiplex diagnostics for sexually transmitted infection, antibiotic resistance markers, and respiratory disease.