An automated optical device that uses direct visualisation of single molecules for routine screening of cancer biomarkers.

SMi is developing a new technology that analyses patient samples by directly visualising the single molecules that are responsible for different diseases. Using this approach SMi applies a patient sample to the surface of its consumable diagnostic chips and places these chips inside a specialised, benchtop, super-resolution microscope that can scan a large number of samples (96 or 384) in less than 1 second per patient. This resolution is unprecedented in diagnosis and yields an extremely high quality of accurate data that includes the exact number of disease particles. This enables clinicians to rapidly diagnose patients and to monitor disease progression.

SMi prints a microscopic pattern of diagnostic reagents onto the diagnostic chips which allows multiple diseases to be tested simultaneously. Such an approach is ideal for cancer as an improved diagnosis is given when a pattern of cancer particles (termed biomarkers) are screened at the same time. In 2018, a clinical study of 1005 patients identified 100 biomarkers that could be used for accurate diagnosis, but their routine use is hindered by the complexity of current test procedures, the high level of training/expertise required, the time needed to run tests, and their prohibitive costs. SMi's new technology is ideal for utilising these biomarkers as it can directly visualise and count the exact number of each different one.

In this research project, SMi will micro-print reagents that detect these biomarkers onto its consumable diagnostic chips. When a patient sample is added to the chip, SMi will use complex mathematical formulae to analyse the pattern of results to predict the diagnosis. The use of biomarkers that have already shown success allows the original results to be reappraised and for SMi to prove that its technology produces a similar outcome. Importantly, by partnering with the Medicines Discovery Catapult (a national research laboratory at Alderley Park) SMi can test samples on its own pre-production devices and compare these to the same samples tested on other devices that are commonly used in a clinical setting.

A positive outcome from these experiments would validate a valuable set of cancer biomarkers, transform their use for routine cancer screening, and allow real-time monitoring of treatment efficacy. As SMi's technology can visualise any single molecule, a successful validation of the approach in this study would provide further evidence to support adoption of this ground-breaking technology for diagnosis of numerous other diseases, both infectious and non-infectious.