FIND brings differentiation of gonorrhoea and chlamydia one step closer to primary care in the race against the rise of "super-gonorrhoea"

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• Axxin and DCN will both receive support to continue the development of rapid, low-cost tests that are urgently needed to curb the rise of untreatable “super-gonorrhoea”
• These rapid tests will allow targeted use of antibiotics by identifying Neisseria gonorrhoea (NG) from Chlamydia trachomatis (CT) at primary health care in resources constrained settings
• This announcement follows the conclusion of a competitive evaluation to accelerate development of technologies that could meet recently published target product profile requirements

Geneva, Switzerland – 25 May 2020 – The Foundation for Innovative New Diagnostics (FIND) announced today that tests from Axxin Pty Ltd and DCN Diagnostics, Inc. (DCN Dx) have met criteria for continued development support from the non-profit organization. The support offered is part of a package to accelerate development of rapid, low-cost tests that can distinguish NG from CT infections in primary health care settings (PHC), which are urgently needed to curb the rise of untreatable “super-gonorrhoea”. Alongside funding, FIND is providing project assistance and technical expertise, as well as resources including reference samples for rapid assay development and assessment, and antibody reagents for capture and detection of NG.

Axxin is developing a point-of-care nucleic acid molecular diagnostic, while DCN Dx is working on a lateral flow assay for NG and CT; both tests can be used at PHC and provide a diagnosis in under 30 minutes. The two partners were selected after both tests were shown to meet target product profile (TPP) requirements recently set out by FIND and the World Health Organization (WHO) to address point-of-care diagnosis of gonorrhoea, as well as determine susceptibility to existing antibiotics.[1],[2] TPPs are part of a stewardship plan by WHO and the Global Antibiotic Research and Development Partnership (GARDP) to protect antibiotics for as long as possible, and curb the spread of drug-resistant infections, including super-gonorrhoea, as part of the global fight against antimicrobial resistance.

More than 1 million cases of curable sexually transmitted infections (STIs) – chlamydia, gonorrhoea, syphilis and trichomoniasis – are diagnosed worldwide, every day. After chlamydia, gonorrhoea is the most common STI, with around 87 million cases worldwide.[3] Complications from gonorrhoea disproportionally affect women, and include pelvic inflammatory disease, ectopic pregnancy, and infertility, as well as increased risk of transmission and acquisition of HIV. The rise of antibiotic-resistant super-gonorrhoea in recent years is a huge cause for concern.

“We welcome the opportunity to work with FIND to develop new tests for these important global diseases,” said Bill Hopper, Technical Director of Axxin. “There is an urgent need to expand access to high-sensitivity, highly specific tests in low-middle income countries.  The application of an innovative instrument and cartridge platform can significantly reduce the overall cost of a deployed molecular assay in point-of-care environments.  We are very committed to the FIND collaboration where widespread roll-out of low-cost point-of-care tests will enable precise targeting of antibiotics and will reduce the emergence of drug-resistant infections”.

“We have a window of opportunity in which to curtail the spread of super-gonorrhoea,” said Catharina Boehme, CEO of FIND. “Tests to differentiate gonorrhoea from chlamydia – that can be used even in the most resource-constrained settings – are badly needed. Presentation of these diseases is often too similar to tell them apart based on symptoms alone. We must provide healthcare professionals with the tools they need to treat their patients correctly and prevent the development of resistance to critical antibiotics that we rely on the world over.”

Both tests are expected to be ready for clinical trials and field evaluations by March 2021.

This work is supported by the Global Antimicrobial Resistance Innovation Fund (GAMRIF), a UK aid programme.
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[1] FIND & World Health Organization. Target product profile for a test to identify susceptibility/resistance of gonorrhoea to antibiotics to facilitate antibiotic stewardship. https://www.finddx.org/wp-content/uploads/2019/09/Comprehensive-NG-test-TPP_20190731_clean-who.pdf (accessed 29 October 2019)

[2] FIND & World Health Organization. Target product profile for a rapid, low-cost diagnostic to distinguish gonorrhoea from chlamydia infection at primary care. https://www.finddx.org/wp-content/uploads/2019/09/NG_CT-Test-TPP_20190731_clean-who.pdf (accessed 29 October 2019)

[3] World Health Organization. Report on global sexually transmitted infection surveillance, 2018. https://apps.who.int/iris/bitstream/handle/10665/277258/9789241565691-eng.pdf?ua=1 (accessed 29 October 2019)

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About FIND
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policy-makers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the development of 24 new diagnostic tools used in 150 LMICs. Over 50 million FIND-supported products have been provided to our target markets since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control and prevention.

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