Public Funding for Eluceda Limited

To support initiatives across the NHS to prevent healthcare-associated infections and the transmission of dangerous antimicrobial resistant pathogens, Eluceda Limited in collaboration with Infection Prevention and Control experts at the University of Manchester and Manchester University NHS Foundation Trust, aim to advance the development and validation of a novel device which allows pathogenic bacteria to be identified and microbial load quantified in the hospital and healthcare environment, providing essential knowledge about microbial contamination to facilitate short-term remedial actions and long-term hospital hygiene improvement plans. The technology is based on state-of-the-art detection techniques that enable the analysis of multiple pre-specified microorganisms simultaneously from a single swab of a high-frequency touch surface within the hospital environment, healthcare workers hands or instruments. The innovative solution, consisting of a simple to use cartridge and hand-held reader, will be an automated test for low-cost and rapid evaluation of environmental contamination in a standardised format, with the ability to simultaneously identify key pathogens responsible for most healthcare-associated infections, including _Clostridium difficile_, _Pseudomonas aeruginosa_ and _Acinetobacter baumanii, Escherichia coli and_ Methicillin-resistant _Staphylococcus aureus_ (MRSA). As an environmental monitoring and quality control test with supporting database and analytics, hospital infection prevention and control teams and professional cleaning service providers will be able to monitor the effectiveness of disinfection products and cleaning regimes for compliance, investigate outbreaks, improve hygiene standards and test the efficacy of new interventions to improve patient safety and resource efficiency.

This project aims to develop a novel testing solution that allows the complete forensic fingerprinting of a range of aqueous consumer products (including pharmaceuticals and scotch whiskies) to reduce the number of counterfeit products that are able to be sold on the black market. This technology is based of novel state-of-the-art detection techniques developed by Eluceda Limited and utilising an electronic testing system to achieve a comprehensive analysis of specific legitimate products in an effort to support brand owners and government agencies in finding and removing these from sale. The innovative solution, consisting of disposable electrodes and reader, will be an automated test for simple, low-cost, portable and rapid evaluation of products at the source of suspicion in a standardised format. Requiring minimal technical training, the technology will be able to be used by a range of user groups and will initially be targeted at certain pharmaceuticals, scotch whiskies and cognacs, with rapid expansion to other pharmaceuticals and alcoholic spirits. This will be aided by the development of a bespoke, secure and segregated database which allows low levels of latency and rapid statistical analysis of previously testing samples to ensure the assessment represents an efficient use of time. The solution will be aimed at (expected market entry 2023 following scale-up and test marketing) at alcohol brand owners/pharmaceutical companies, government agencies and re-selling companies, most interested in abating the supply of fake goods. Globally, the counterfeit trade accounts for 3.3% of global trade (OECD, 2019 report) with a value of £400 billion globally (Fact UK, 2019), which has been estimated to be increase by up to 20% per year for pharmaceuticals, showing no signs of slowing. By enabling users to detect counterfeit products easily and quickly at source, end-users will be able to comprehensively remove these products from circulation, limiting the opportunity for criminal organisations to continue their operations. This will not only offer a significant financial benefit (EU government alone, lost £2Bn in tax revenues from counterfeit alcohol) but also protect the consumer from the potentially drastic impact of illicit goods (serious health implications, even leading to death, see Ksalol counterfeit pharmaceuticals in Ireland, 2020). Eluceda Limited aims to revolutionise the portable counterfeit detection market, a completely new market which is growing rapidly due to the increases in counterfeit goods, particularly due to the impact of the COVID-19 pandemic. Eluceda will seeks to exploit the solution across multiple end use applications where the rapid and on-site detection of fake goods is a key priority in terms of economic protection, environmental sustainability and the health and safety of the consumer.

**CHALLENGE:** Healthcare-associated infections (HCAIs) pose a serious threat to patients, staff and visitors, and significant cost to the NHS (£1billion/year). Infection prevention and control is therefore a key government/NHS priority and has generated significant public attention over the last decade.Appropriate disinfection of high-touch surfaces and equipment is necessary to reduce the transmission of dangerous pathogens, including _Clostridium difficile_, and antibiotic-resistant organisms such as methicillin-resistant _Staphylococcus aureus_ (MRSA) and Vancomycin-resistant enterococci (VRE). The Centres for Disease Control and Prevention (CDC) has encouraged hospitals to develop environmental cleaning and monitoring programmes to optimise the cleaning practices, and ensure quality control and improvement. However, a current lack of standardised methods for monitoring the hospital environment, the comparative effectiveness of disinfectants, application methods and adherence to cleaning protocols, means that no consensus exists around benchmarks for cleanliness.**INNOVATION:** Eluceda is developing a rapid (result in 20-min), cost-effective (£1/test) diagnostic tool with confirmatory microbial identification of critical HCAI pathogens from a surface swab for environmental monitoring, initially targeted at the hospital/healthcare sector. There is no equivalent benchmark product on the market.**PROJECT OBJECTIVES:** Feasibility testing has proven that an electronic sensor can rapidly detect microorganisms that cause the majority of HCAIs. This project aims to develop a proof-of-concept test, reader and electrodes that can detect multiple microorganisms simultaneously:1) Determine the extent of risk that dead bacteria pose to the assay and develop countermeasures;2) Optimise a one-pot polymerase chain reaction (PCR) system to amplify bacterial DNA;3) Design and develop multiplex electrodes;4) Develop a primer ink that holds each selected test DNA in place on the electrodes; and5) Design a reader that can detect multiple signals simultaneously (6 working, one counter and one reference).**IMPACT:** The technology offers a market-disruptive QA test to allow hospitals to routinely monitor cleaning protocols at low cost and with little staff training. Market entry 2022\. Test results will enable immediate actions to be implemented and long-term improvements in cleaning/auditing facilities to reduce the spread of HCAIs and associated healthcare costs.**EXPLOITATION:** Eluceda seeks to establish a JV/licensing deal with a provider of professional disinfectant products to the healthcare/other hygiene critical markets (e.g. Arch UK Biocides, Ecolab, Nationwide Hygiene, Guest Medical, GV Health). These companies are seeking innovative technologies to complement their disinfectant product portfolio in a similar way 3M/Hygiena does with ATP test kits (current benchmark) and would sell test consumables through established sales/distribution channels.

Eluceda Ltd will develop the next generation of biosensors; a platform able to operate in a wide variety of environments and making sensors truly democratic and ubiquitous. We will use our expertise in device development and optimisation to make these tests easy to use and accurate. These devices will be able to contribute to reducing product counterfeiting, speeding up drug production, making production safer and analysing waste streams. The feasibility study we will pursue will provide a valuable candidate for a sensor platform that can be used to detect markers in a wide variety of harsh solutions.