A new diagnostic test for breast cancer can give patients and doctors a treatment decision in days instead of months, using infrared light and artificial intelligence to analyse standard tumour biopsies. The problem is that current risk-profiling tests for breast cancer are expensive, slow, and available only to a narrow group of patients. Digistain measures how rapidly a tumour is likely to grow by reading how infrared light passes through a biopsy sample. In completed clinical trials involving over 1,200 patients, the test matched the accuracy of the best genomic tests but at a fraction of the cost. This matters because many patients currently receive unnecessary chemotherapy while waiting weeks for test results. This project will run a double-blind study on an additional 250 patient samples to fill evidence gaps identified in recent NICE guidance. If successful, the test could be adopted across the NHS, giving more patients rapid access to personalised treatment decisions and sparing those with low-risk cancers from chemotherapy they do not need. The technology has already been designed with input from over 1,500 oncologists.
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Digistain is a patented 'companion diagnostic' technology that assesses breast cancer proliferation risk severity utilising standard breast cancer tumour biopsies to guide adjuvant chemotherapy decisions. The technology is disruptive for breast cancer risk diagnosis, based on a new methodology using Infrared Light transmission/absorption combined with unique artificial intelligence and machine learning algorithms. In (completed) double-blind clinical trials, Digistain has proven to be extremely effective vs incumbent technologies. Digistain allows for faster breast cancer treatment decision making data for physicians and patients, reducing informed actionable treatment decision times from months and weeks to days and hours, all at a dramatically lower cost. Digistain personalises critical care decisions and predicts individual patient outcomes which can lead to the avoidance of unnecessary chemotherapy treatment. The technology has been designed with input from over 1,500 oncologists and successfully trialled by over 1,200 patients in prominent cancer centres across the UK and EU. Digistain has undergone several clinical studies demonstrating a prognostic score equivalent to the best-in-class genomic tests. This project will allow timely exploitation of this prior work and achieve validation of Digistain in a diverse patient population. This i4i Connect project will develop the evidence base necessary for wide-scale NHS adoption and beyond. The study design has been driven by interviews with NHS stakeholders, where feedback showed a second validation study was necessary for wide-scale adoption. Particular focus has been given on filling evidence gaps identified in latest NICE guidance (DG58) that have determined the narrow eligibility criteria of risk profiling tests for adjuvant therapy guidance. Therefore to bridge this gap, we plan to expand our dataset by conducting an observational double blinded (retrospective-prospective) study, recruiting and assessing an additional 250 patient samples, to ensure our clinical validation meets the necessary threshold for NHS adoption. Project exit point: This project will make Digistain (with early development funded by an NIHR impact award) market ready and deliver UK social impact immediately.
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