Tackling A Global Health Problem: Antimicrobial Resistance (AMR)

Pictured: SpeeDx founders Alison Todd and Chief Technology Officer Elisa Mokany. Photo by Michael Amendolia

Antimicrobial Resistance (AMR) is recognised by the World Health Organisation (WHO)[1] as an urgent global health priority affecting humans, animal health and agriculture; resulting in the organisation putting together a global action plan in 2015.

NSW-based company SpeeDx, along with key collaborators such as Melbourne Sexual Health and Royal Women's Hospital, Royal Brisbane Hospital and NSW Health Pathology; is tackling AMR head-on by developing diagnostics that can detect infectious diseases and markers for antibiotic resistance. The test is called ResistancePlus® and currently targets sexually transmitted infections (STIs) that have the potential to become the first incurable bacterial infections.

SpeeDx’s ResistancePlus® tests are rapid molecular diagnostics that identify the infecting organism as well as the resistance status of the infection; and can uniquely screen for the multiple and often complex genetic mutations that are linked to AMR. The test combines a diagnostic approach that supports resistance guided therapy, empowering clinicians to make informed treatment decisions. Resistance guided therapy leads to faster and more effective cure rates for patients, ensuring appropriate and effective treatment while working to minimise the spread of AMR and improve antibiotic stewardship of existing treatment options.

The ResistancePlus® MG test detects Mycoplasma genitalium (Mgen) and five mutations linked with resistance to the frontline treatment Azithromycin. Early-access laboratories have seen positive results when using ResistancePlus MG to guide treatment options, identifying resistant infections and ensuring the right antibiotic is prescribed, this has improved overall cure rates for patients and lessened the risk of complications from long-term infections.

CEO of SpeeDx Colin Denver explained that seeking collaborators was the key to advancing their technology forward.

“In order to develop diagnostic tests that have true utility, SpeeDx has established strong relationships with physicians and clinicians on the front-line,” Mr Denver said.

“Our unique technology advantage coupled with our focused Australian research and manufacturing teams allows us to rapidly respond to market needs.”

SpeeDx’s work with antimicrobial resistance is aligned with MTPConnect’s 10-year Sector Competitiveness Plan (SCP), linked to key megatrends and knowledge priority areas identified as future areas of need. The project is also fostering a highly collaborative environment for accelerating commercialisation. SpeeDx engages with key clinicians and leading researchers around the world including Australia, the UK, and the US, to identify areas of clinical diagnostic need.

SpeeDx recognises that there can be challenges related to market education as well as the public’s limited knowledge when developing market-leading tests. Work to address these challenges includes raising awareness on how best to incorporate the innovative technology into laboratory test menus in addition to supporting key research and publications in relevant areas.

ResistancePlus® MG tests allow STI clinics to gain upfront AMR information and improve patient care, and now STI management guidelines around the world are being updated to include recommendations for resistance testing to better manage the rise of AMR in Mgen. Melbourne Sexual Health have reported that since using resistance guided therapy they have increased overall cure rates of Mgen infections from 60% to over 92%[2].

SpeeDx has identified the next target for ResistancePlus® to treat the growing threat of AMR in gonorrhea infections. The ResistancePlus GC test will identify infections susceptible to ciprofloxacin, an older antibiotic that could be used in place of existing frontline treatments. SpeeDx’s unique pipeline of ResistancePlus® tests provide the individualised information needed by infectious disease clinicians in Australia and around the world, helping them to combat AMR and improve antibiotic stewardship.

ResistancePlus MG is now being used in over 80% of Australian laboratories and multiple countries throughout Europe, with clinical trials underway in the U.S. in preparation for FDA submission later this year.

For more information on SpeeDx and its tests into fighting AMR, visit https://plexpcr.com.

[1] WHO Global Action Plan on Antimicrobial Resistance http://www.who.int/antimicrobial-resistance/globa...

[2] T R H, Fairley C K, Murray G L, et al. Outcomes of resistance-guided sequential treatment of Mycoplasma genitalium infections: a prospective evaluation, Clinical Infectious Diseases, ciy477, https://doi.org/10.1093/cid/ciy477