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SpeeDx Receives CE-IVD Mark for ResistancePlus® GC

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 gonorrhoea treatment

SYDNEY, AUSTRALIA–(December 6th, 2018). SpeeDx Pty. Ltd. announced today 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 gonorrhoea management guidelines that include the preferential use of ciprofloxacin over ceftriaxone if antimicrobial susceptibility results are available prior to treatment.5 Ceftriaxone, a painful intramuscular injection, is the current front-line treatment for gonorrhoea 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.

About N. gonorrhoeae
N. gonorrhoeae is a bacterium causing gonorrhoea, a sexually transmitted infection most frequently causing urethritis in men and cervicitis in women. Gonorrhoea can result in infertility or ectopic pregnancy and also increases risk of acquisition of other STIs, including HIV. Vertical transmission from infected mothers to newborns during birth can result in gonococcal conjunctivitis - infection in the eye (ophthalmia neonatorum).

Prevalence and incidence rates of gonorrhoea have been increasing around the world, with corresponding increasing rates of resistance to commonly used antibiotics.6 Recent studies suggest N. gonorrhoeae is threatening to become untreatable as resistance continues to develop against all known antimicrobials.6 The currently recommended front-line treatment, ceftriaxone, is the last known effective antibiotic, and several extensively drug resistant strains have now been isolated exhibiting resistance to this and many other available treatments.7,8  Global management strategies for antimicrobial resistance highlight gonorrhoea as a priority infection to manage, with more effective use of diagnostic tools listed as a key focus for future development.9

About ResistancePlus®
ResistancePlus® kits are multiplex qPCR tests for detection of infectious diseases and antibiotic resistance markers, respectively. Powered by proprietary PlexZyme® and PlexPrime® technologies, the product line offers high multiplexing capability for better, more streamlined infectious disease management. ResistancePlus tests offer more than detection, supporting Resistance Guided Therapy by providing actionable information for laboratories and clinicians alike.

About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the U.S., and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease. For more information on SpeeDx, please see

1. Harris SR et al. Lancet Infect Dis Published online May 15th 2018.
2. Lahra MM et al. Australian Gonococcal Surveillance Programme annual report, 2015
3.Heffernan H et al. Antimicrobial resistance and molecular epidemiology of gonococci in NZ, 2014-5
4.  Kirkcaldy RD et al. MMWR Surveillance Summaries July 15, 2016 / 65(7);1–19
5. Fifer H. et al. 2018 UK national guideline for the management of infection with Neisseria gonorrhoeae (Draft).
6. Unemo, M. & Jensen, J.S. 2016. Nat. Rev. Urol..268. Published online 10 Jan 2017. doi:10.1038/nrurol
7. PHE Health Protection Report Volume 12, Number 11. 2018
8. AU DoH Media Statement April17th 2018.
9. Rapid Risk Assessment 7 May 2018. Stockholm: ECDC; 2018.

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