Sensor and Rapid Assay for Diagnosis of Invasive Fungal Infections

New innovations in fungal disease detection are a medical priority and the benefits of advanced biosensor methodologies have yet to be exploited in this field. Invasive fungal infections (IFI) generate global mortality figures that are comparable to or exceed those due to malaria, HIV and tuberculosis.

Our aim is to complete the development of a sensor assay to prepare to commercialize the first electrochemical rapid in vitro diagnostic screening test for IFI.

There is an immediate market opportunity for commercialising our sensor and assay because there is currently only one gold-standard test for IFI in use in UK clinics which uses live horseshoe crab extract as one of the reagents and which can result in false positive and negative assay results because components from blood samples can interfere with the complex reagent.

Our sensor assay is based on electrochemical detection on a sensor strip which is assembled in the laboratory using inexpensive electrode materials and including nanoparticles and enzymes prepared using standard protein preparation methods. Importantly, our electrochemical sensor does not require live animal extracts yet provides a level of sensitivity that allows the detection of IFI in blood, with already a sensitivity comparable to the Fungitell assay (Associates of Cape Cod, Inc).

We have measured the first datasets with human blood samples obtained from Public Health England (Microbiology Services Division, Mycology Reference Laboratory, UK HSA South West Laboratory). Our sensor qualitatively reproduced the results of a Fungitell assay. By optimising and completing the sensor development, our sensor assay provides important advantages over existing IFI assays, which are: adequate sensitivity that is similar or better as compared to gold-standard Fungitell assay; sensor assay does not use live animal extracts; reagents are produced using standard methods from chemistry and biochemistry.

The clinical community needs fungal diagnostics and assays that are portable and ideally do not require refrigeration to address the growing market for IFI assays for use in the clinic but also in limited resource settings.

We apply for the BBSRC Follow-on Fund to complete the development of our novel IFI sensor and assay previously supported by the UKRI Strategic Priorities Fund Building collaboration at the physics of life interface (EP/T002875/1, ended 9/2022), to collect the datasets working with patient samples, users in academia and in the clinic to file a patent application and to take the next steps in commercialising the sensor assay by developing a portable sensor, together with industry or in-house, and fielding the portable instrument for first tests by users in the clinic. We will continue to develop our business plan together with a dedicated team at the Technology Transfer Office (TTO), based at the University of Exeter's Innovation, Impact and Business (IIB) Directorate with the aim of research commercialisation and setting up a spin-out company.

The sensor technology makes use of previous technologies developed in the PI's laboratory as part of UKRI Strategic Priorities Fund Building collaboration at the physics of life interface ( EP/T002875/1).