Public Funding for Microbiosensor Limited

From niche 'in clinic' diagnostic to high-volume home-use medical product

Patients with advanced kidney disease, who are reliant on peritoneal dialysis (PD), and advanced liver disease patients, with liver cirrhosis, are both at risk of life-threatening infection in the abdomen, referred to as 'peritonitis'. This develops quickly, and typically requires hospital admission. The choice of antibiotic therapy has to be made by doctors 'blind', based on an educated guess. After around 4 days antibiotic susceptibility information arrives from the hospital's centralised microbiology laboratories. Frequently the choice of antibiotics is then modified, however by then the infection may have progressed appreciably, in many cases fatally, and most patients are extremely ill. Managing these patients is very expensive for health-care providers, with this exacerbated as PD patients must permanently switch to more expensive haemodialysis. There is an urgent need for doctors managing these critically ill patients to rapidly and reliably obtain antibiotic sensitivity information. Microbiosensor is a Manchester-based company developing products miniaturising and speeding up conventional high quality hospital microbiology tests. These are made available in a simple, and inexpensive form for use at the bedside with vulnerable patient groups. We have previously developed a device (QuickCheck) to screen for peritonitis in the homes of PD patients, where the therapy is normally carried out. This test takes ten hours (running alongside overnight PD as the patient sleeps) and if positive initiates further hospital antibiotic sensitivity investigations. We are currently developing a product for elderly urinary tract infection patients in care homes, quickly providing antibiotic susceptibility information (STAR). The proposed PeriFAST product is our most ambitious yet, and will test peritoneal fluid from both liver and PD patients, which of 10 antibiotics will be effective in four hours, displaying this information clearly on an electronic screen. We will work in a consortium with two long-established UK companies. Tagdraw Ltd (trading as Smallfry) are an innovative design consultancy for medical products and Datalink Electronics are a contract high technology electronics design and manufacturing company. In the project we will adapt our chemistry for use with new antibiotics and liver patients, design a disposable cassette to house the test, develop an electronic reader to provide the result, check the new system works with real peritonitis samples and manage the IP. By project end, we will be ready for the product to enter its final clinical assessment before CE marking. The product will be sold on an annual tariff basis, and address large potential global markets.

"The misdiagnosis and incorrect treatment of Urinary Tract Infections (UTIs) is a significant global healthcare problem and a contributory factor to growing antibiotic resistance levels. UTIs are the most common non-intestinal infection in women worldwide (over 15-million new infections p.a.). In the UK they are the 3rd most common reason for emergency admission via A&E, with over 180,000 A&E admissions p.a., costing the NHS £434M (2013/14). Due to a delay of 3-days (or more) between sending suspected UTI samples off for hospital tests and receiving the diagnostic results back, doctors are forced to make an educated guess as to the nature of the infection and what the most effective antibiotic treatment might be. This guess is often incorrect and the infection resistant to the antibiotic prescribed. This leads to a worsening of the infection and can result in the patient being hospitalised, introducing short-term risks for patient health and long-term societal risks from growing antimicrobial resistance. Microbiosensor is developing a simple, disposable medical device to address this market need. The 'Same-day Test for Antibiotic Resistance' (STAR) we propose to develop with Innovate UK funding will miniaturise and simplify conventional hospital microbiology. STAR relies on a colour change reaction to signal the presence of live bacteria and combines i) a disposable 'cassette' device which processes the urine sample via a series of chemical reaction chambers and ii) a re-usable incubator instrument into which the cassettes are inserted, which automates the sample analysis and speeds diagnosis. Instead of sending samples off to the hospital lab, STAR will ""bring the lab to the patient"", in an easy-to-use format and at a fraction of the cost of existing analytical platforms. This will allow care homes, pharmacies and GP surgeries to benefit from 'same-day' diagnostic services: testing potential UTI samples and prescribing targeted antibiotic treatments if an infection is detected later that afternoon. A precision medicine approach to UTI treatment will therefore speed the time to an effective treatment, improve patient care and help preserve the dwindling arsenal of effective front-line antibiotic drugs."

Increasing numbers of people are suffering from kidney failure, particularly resulting from diabetes. Patients with kidney failure can have two types of dialysis; Peritoneal- or Haemo-dialysis. Peritoneal dialysis can be done at home and gives the patient the most freedom and flexibility, it is also cheaper than haemodialysis. However, it carries a risk of serious infection, and often by the time infection becomes obvious, it can be life-threatening. The project aims to develop a simple new test which can help patients to detect infections at an early stage. This means that treatment could be started more quickly and the infection controlled more easily. The test also gives additional information to the medical team, allowing them to choose the best treatment. The idea for the new test came from the University of Manchester where researchers have been working on detection of bacteria using a colour change reaction. Microbiosensor Ltd are now working to fully develop this test, and a way of manufacturing a reliable, easy to use product. Dialysis patients have been involved in designing the product, and making sure it is easy to use. In this project the new test will be developed so it is ready to be tested by patients.