Public Funding for Digistain Limited

Most cancers are first discovered when they manifest themselves physically. In the case of breast, a lump is found, and a biopsy is taken with a hollow needle. The tissue sample is fixed in formalin, embedded in wax, and slices are stained with dyes and mounted on a microscope slide. The slide is then visually evaluated using an optical microscope, using a long-established protocol, to decide its grade and how far the disease has progressed. The grading is a subjective process, however, and trials show that 2 different pathologists only agree, in the case of Breast Cancer, ~70% of the time. They respond to this uncertainty by over treating and giving chemotherapy when it may not be needed. This is dangerous and a 2009 national patient enquiry concluded it was the **primary cause of death in 27% of cancer deaths** in the UK. Digistain measures the biopsy tissue's absorption of mid-infrared light at wavelengths corresponding to the proteins and the DNA. The DNA fraction can then be quantified in a Digistain index (DI), a well-known biomarker (aka nuclear-to-cytoplasmic ratio, NCR), because it elevates in Cancer when the cells divide more frequently and make more DNA than do healthy cells. Digistain is objective, and the added security it brings allows chemotherapy to be avoided when it is not needed. The Digistain test fits very well into existing H+E pathology workflows and adds no patient procedures. Also, the preserved biopsies are archived in hospitals, complete with medical follow-up records. This allows Digistain to be trialled over large patient cohorts post hoc, in a comparatively quick and inexpensive way. This has accelerated its path to market where it now right now has approval for Breast. We now seek acceptance by NICE, the body that authorises treatments on the UK NHS system. This project will establish standard samples that will allow us to test Digistain machines and validate that the DI data they generate are trustworthy enough to be used as the basis for have life-changing treatment decisions Because it uses the NCR, there is good reason to believe that Digistain will also be effective in many other types of cancer. A recent independent analysis, funded by Innovate UK, has concluded that were it to be adopted across the NHS, for Breast Cancer alone, it would result in savings of £287M per annum, 450 tonnes of CO2, and 1266 life-years

Digistain is a market-ready, UK-based clinical diagnostics company transforming breast cancer treatment to save time, money, and lives. Where current companion diagnostics delay treatment decisions for up to a month, our technology provides oncologists with decision-making data in just 15 minutes. This means chemotherapy can be avoided where appropriate and enables patients to avoid the unnecessary increase in the risk of death caused by chemotherapy toxicity by 50%. When chemotherapy is required and initiated immediately, time makes the difference between life and death with every 30-day delay increasing the chance of death. Digistain enables oncologists to leapfrog currently available technologies to provide superior care quickly and affordably. Our founders, Dr Chris Phillips and Dr Hemmel Amrania hold PhDs from Cambridge and Imperial College London respectively and have won multiple research awards for this innovation already. Digistain has been trialled with leading British cancer treatment centres including Imperial College Healthcare, Nottingham University Hospitals NHS Trust, and Barts Cancer Institute at Queen Mary University London. While other risk profiling solutions use a fixed assessment of data from wet chemistry analysis, Digistain leverages machine learning to identify patterns invisible to fixed algorithmic approaches. Digistain captures a unique spectral signature from each biopsy and performs analysis on over 10,000 data points per biopsy. With this information, Digistain's artificial intelligence process computes an accurate risk score which has been validated on over 800 patients in a study reviewed by Cancer Research UK. The study demonstrated superior clinical performance to the incumbent. Digistain offers a significant advantage over the existing state-of-the-art technology. Currently, oncologists must wait several weeks for test results. The aim of this project is to guide adjuvant (post-surgery) therapy decisions to improve patient outcomes, promote UK economic growth, and save lives -- all while reducing care inequalities by being affordable to more patients.