Public Funding for Cotton Mouton Diagnostics Ltd

Bacteria do not have to be whole and 'alive' to cause problems. If certain cell components enter the blood stream the consequences can be life threatening. Endotoxin is one such component. Found in high-concentrations in the cell wall of many bacteria, including those resident in the human GI tract, endotoxin is the most potent mediator of inflammation known to man if it gets into our bloodstream. It is possible to introduce endotoxin into the blood stream accidentally. For instance, if an injectable medicine, or other pharmaceutical product such as saline or a vaccine, is contaminated with endotoxin, then the very act of administrating the medication will also deliver a potentially lethal dose of endotoxin. It is therefore essential that all injectable products are screened for endotoxin prior to release to the market. The current regulatory approved method for testing for endotoxin uses a product derived from the blood of the horseshoe crab. Current tests are perceived by end-users as slow, imprecise, lacking in sensitivity and generally unsuited to modern forms of production. As demand for injectable medicines grow, so does the need for a better approach to endotoxin testing including the reduced consumption of crab-derived reagent. To address these needs CMD has developed alphaBET, a CE marked instrument that uses regulatory approved reagents in a novel manner to deliver the next generation bacterial endotoxin test. alphaBET outperforms all current marking leading methods in terms of speed, precision, accuracy, reliability and affordability and importantly uses a fraction of the reagent used in currently used tests. The proposed project is the next step in alphaBET's journey to commercialisation. The IUK loan will support submissions for regulatory approval for alphaBET in UK, Europe and US, put appropriate quality management standards in place, complete preparations for large-scale manufacture of the instrument and the consumable test-cartridge and allow CMD to recruit key staff ahead of predicted first sales in Q1 2022.

Since the realisation that a new coronavirus was responsible for a cluster of pneumonia cases in China on 9thJanuary, more than 2 million cases and 135,000 deaths have been reported across the globe. The so-called 'COVID-19' pandemic has put healthcare systems under enormous pressure and has resulted in global economic collapse as a result of quarantine and social distancing policies being implemented. Governments across the world struggle to lift lockdown measures for fear of a bounce-back in the number of cases and fatalities. In this project, we aim to develop a test that will allow people to be checked to see if they are immune to the virus. These tests would be carried out in a community pharmacy or at a GP surgery to allow for widespread testing. Those people shown to have immunity would potentially be able to return to work or look after vulnerable friends / family without fear of either catching or passing on the virus. The Extension for Impact funding will allow us to use our system to test more clinical samples and put the necessary processes in place to expedite regulatory approval and release to market.

Cotton Mouton Diagnostics Ltd CMD is developing a highly innovative magneto optical sensing platform that exploits changes in the rotational behaviour of magnetic reporters naturally occurring or artificially introduced observed via the Cotton Mouton effect. CMD is applying the technology to the field of in vitro point of care PoC diagnostics. Long running research programs funding of 2M from the EU and Gates Foundation have already developed and field tested, on more than 1,000 patients, a malaria in vitro point of care PoC diagnostic. Building from the excellent platform utility demonstrated in these niche clinical studies CMD aims now to develop a disruptive and generic multiplex detection platform targeting human and veterinary in vitro PoC diagnostics. This project will see CMD recruit and develop management, advisory and technical teams so as to deliver a fully functional and commercial investment ready technology company within 18 months. Aid for Start ups AFS will deliver added value to an existing Innovate MedTech Launchpad project, which is focused on the development of a multiplexed sepsis PoC diagnostic, by supporting commercial and regulatory aspects of product development whilst also resourcing the technical development of two further products and an experienced business team to explore market opportunities and product commercialisation.

Cotton Mouton Diagnostics (CMD) is a start-up company based in South Wales. CMD's vision is to deliver innovative, fit-for-purpose, point-of-care diagnostic technologies based upon a unique magneto-optical sensing mechanism. The technology has been successfully field-tested as a malaria diagnostic, relying on detection of a parasite-derived magnetic marker. CMD now seeks to harness the underlying principle of this sensing approach to transform the technology into a generic diagnostic platform, broadly applicable to any disease. In order to fully exploit the capabilities of the technology, and to meet the demands of the clinical and commercial arenas, CMD need to develop a system capable of simultaneous multi-analyte detection. This project will develop and demonstrate an innovative multiplexed platform based upon unique optical effects arising from the use of synthetic gold-coated nanorods as magnetic reporters. The initial application of the technology will be in the diagnosis of sepis; a condition that affects 20 - 30 million people worldwide each year and kills one person every few seconds.