New Combined Diagnostic and Antimicrobial Susceptibility Test Enables Resistance-Guided Therapy for Gonorrhoea
- Updated 2019 guidelines for the treatment of Neisseria gonorrhoeae now recommend use of ciprofloxacin, provided susceptibility to the antimicrobial has been demonstrated
- Over 70% of UK gonorrhoea patients could benefit from using this cheaper, easier, oral antibiotic
- ResistancePlus® GC molecular diagnostic test now available in the UK simultaneously diagnoses gonorrhoeae and provides antimicrobial susceptibility information, overcoming many of the issues associated with culture-based methods (time, ability to get isolates)
- Resistance-guided therapy helps in the battle against increasing antimicrobial resistance (AMR) and supports antibiotic stewardship
SYDNEY, Australia and LONDON, UK, January 24, 2019 / B3C newswire / -- UK patients with N. gonorrhoeae (GC) now have the option of receiving the cheap and easily-administered oral antibiotic ciprofloxacin thanks to updated treatment guidelines and the availability of a novel molecular diagnostic and antimicrobial susceptibility test (AST). The new test can simultaneously diagnose gonorrhoea and provide information on whether a patient will respond to ciprofloxacin.(1)
Global management strategies for antimicrobial resistance (AMR), such as those developed by the World Health Organisation, highlight gonorrhoea as a priority infection to manage, with more effective use of diagnostic tools listed as a key focus for future development.(2) Today the Health Secretary Matt Hancock, is launching the UK government's 20-year vision to combat antibiotic resistance at the World Economic Forum at Davos, Switzerland.
Ciprofloxacin was the first line antibiotic of choice for uncomplicated gonorrhoea in the past but was relegated to an alternative treatment due to increasing resistance.
"As a clinician, I would like to treat as many gonococcal infections with ciprofloxacin as possible. More than ever, we rely on accurate and patient-focussed diagnostic strategies to detect and treat STIs” said Dr. John White, Consultant in Sexual Health and HIV at the Altnagelvin Hospital, Londonderry and Editor-in-Chief of the International Journal of STDs & AIDS.
The incidence of sexually transmitted infections (STIs) including gonorrhoea is increasing around the world, with corresponding increasing rates of resistance to commonly used antibiotics. The first two cases of multidrug-resistant (MDX) N. gonorrhoeae were reported in the UK at the start of 2019. These follow the first globally reported case of gonorrhoea with high-level resistance to azithromycin and resistance to ceftriaxone in England in 2018.(3)
Called ResistancePlus® GC, the availability of the new test is timely, as the British Association of Sexual Health and HIV (BASHH) has launched its 2019 gonorrhoea management guidelines to include the use of ciprofloxacin, provided antimicrobial susceptibility results are available prior to treatment.(4)
The new test could be critical in the battle against antibiotic resistance, helping physicians to prescribe an effective antibiotic using a resistance-guided approach. Prior to the new 2019 BASHH guidelines, ceftriaxone was the recommended front-line treatment for gonorrhoea together with azithromycin. Ceftriaxone is a painful intramuscular injection. It has long been considered the last readily available effective antibiotic for GC, and several extensively drug-resistant strains have now been isolated exhibiting resistance to ceftriaxone and many other available treatments.(5,6)
“The new guideline now recommends giving double the previously recommended dose of ceftriaxone (now 1g stat). However, they also indicate ciprofloxacin as a first-line option when antimicrobial susceptibility is known prior to treatment.(4)
Not only is this less painful for patients, it is preferable to doctors as it is a cheaper treatment that does not require specialised staff to administer the injection.(7)
“If we can use less ceftriaxone this may also help to stall the further development and dissemination of ceftriaxone-resistant strains within Europe," added Dr. John White.
As the UK now has the lowest reported rate of ciprofloxacin-resistant gonorrhoea at 26%(8), over 70% of patients could now benefit from the new guidelines and receive oral therapy if they have a test result showing ciprofloxacin susceptibility, such as is offered by the test.
ResistancePlus® GC was invented by scientists in Australia and is now able to be accessed by clinicians in the UK. It is the first commercially available molecular diagnostic test providing ciprofloxacin susceptibility information and is well placed to support current laboratory molecular testing workflows. Currently, culture methods are the routine test to determine antimicrobial susceptibility, but results can take days to produce, and many rectal (50%) and the majority of throat (70%) samples can be difficult to culture; ResistancePlus® GC can overcome these limitations.
“We are fortunate here in Europe that most of these infections can potentially be treated with ciprofloxacin using the principles of resistance-guided therapy, provided we have access to accurate and timely resistance information, which is provided by the ResistancePlus® GC assay.
“It’s great to see novel molecular diagnostics moving beyond just binary positive/negative capability, providing results that help manage patients more effectively by enabling tailored treatment," commented Dr. White.
Treating gonorrhoea as soon as possible is very important because gonorrhoea can lead to serious long-term health problems including pelvic inflammatory disease (PID) in women, that may result in infertility, and infection in the testicles in men.(9)
SpeeDx, the company behind the new test, received CE-IVD marking for its ResistancePlus® GC assay at the end of 2018, enabling it to be adopted in all countries where CE-mark is accepted – including the UK. It is based on a PlexPCR method that detects both N. gonorrhoeae (GC) and sequences in the gyrA gene of the bacteria associated with susceptibility to ciprofloxacin, in a single test.
“SpeeDx is proud to have pioneered the development of the new ResistancePlus® GC test which should make a big difference for patients with gonorrhoea. We already successfully developed and launched a number of diagnostic tests for sexually transmitted diseases including the ResistancePlus® MG test launched last year for the detection of Mycoplasma genitalium and resistance to macrolide antibiotics.” added Colin Denver, SpeeDx’s Chief Executive Officer.
About N. gonorrhoeae
gonorrhoeae is a bacterium causing gonorrhoea, a sexually transmitted infection most frequently causing urethritis in men and cervicitis in women as well as rectal and throat infections, particularly in men who have sex with men. 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).
Recent studies suggest N. gonorrhoeae is threatening to become untreatable as resistance continues to develop against all known antimicrobials.(10) Gonorrhoea is the second most common bacterial sexually transmitted infection (STI) in the UK after chlamydia. In 2017, more than 44,676 people were diagnosed with gonorrhoea in England, representing a 22% increase compared to the previous year.(4)
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.
The 2016 AMR review(11) recommended that, by 2020, all antibiotic prescriptions will need to be informed by up-to-date surveillance information and a rapid diagnostic test wherever one exists.
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.
Independent expert comments, previously published
The following independent expert comments have been widely published in the press:
Commenting on Public Health England’s recent announcement about the two MDX gonorrhoea cases, Dr Olwen Williams, President of BASHH said “We are deeply concerned by these new developments and BASHH are working closely with national and local partners to help prevent further spread of multi-drug resistant gonorrhoea.
“To mitigate this risk, it is essential that all parts of the system work collaboratively and help to ensure that culture tests, partner notification measures and tests of cure are in place. We would also like to remind all healthcare providers about the crucial importance of adhering to BASHH guidelines for the management and treatment of gonorrhoea.” (From a press release on the BASHH website)
Lord Jim O’Neill, economist and former treasury minister and author of the 2016 AMR review, and Dame Sally Davies, Chief Medical Officer for England, have both routinely stated that diagnostics are central to tackling antimicrobial resistance (AMR).
Lord O’Neill, has said that “When I am asked what is the single most important intervention that would make a huge difference to AMR it would be diagnostics. We can get all the new drugs we want, but that will only work for a while until they become resistant — we need to permanently reduce the demand — particularly the inappropriate demand. The time and cost savings that could be made with state-of-the-art diagnostics would be “enormous”. (From an article in the Pharmaceutical Journal)
Dame Sally Davies has endorsed this view stating that “Better diagnosis is clearly part of the answer; whether it’s a lab test or an algorithm, I want to see much more use of diagnostics.” She has said that AMR threatened ‘the future of modern medicine’ and that gonorrhoea in particular was becoming increasingly difficult to treat. In 2018 the UK Government announced an extra £11.5 million to tackle antimicrobial resistance (AMR). "With around 44,000 diagnoses of gonorrhoea in 2017 England alone, this is a huge public health concern, particularly as we are running out of effective antibiotics to treat it. It is therefore vital that cases of gonorrhoea are prevented, identified and managed as soon as possible, so I am pleased that the UK government has committed specific funding to help tackle the problem," she said. (From an article in the Daily Telegraph)
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- Trembizki, E. et al. Further evidence to support the individualised treatment of gonorrhoea with ciprofloxacin. Lancet Infectious diseases 16, 1005–1006 2016.
- Rapid Risk Assessment 7 May 2018. Stockholm: ECDC; 2018.
- Public Health England website
- Fifer H. et al. 2019 UK national guideline for the management of infection with Neisseria gonorrhoeae.
- PHE Health Protection Report Volume 12, Number 11. 2018
- AU DoH Media Statement April17th 2018.
- BMC Fam Pract. 2019; 20: 12. doi: 1186/s12875-018-0900-9
- Data from European Gonococcal Antimicrobial Surveillance Programme.
- NHS website
- Unemo, M. & Jensen, J.S. 2016. Rev. Urol..268. Published online 10 Jan 2017. doi:10.1038/nrurol
- 2016 AMR review https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf
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