Start-up's prostate cancer detection software receives CE mark

UK start-up Lucida Medical has completed CE marking for its new machine learning-based prostate cancer detection software, Prostate Intelligence (Pi). 

This milestone enables the technology to be deployed within the NHS and European healthcare systems.

Lucida Medical’s goal is to significantly improve the prostate cancer diagnostic pathway with technology that finds cancer more accurately by analysing MRI, enabling radiologists to save time and patients to receive the best possible diagnosis and treatment. It will help providers offer rapid ‘one stop shop’ diagnosis, enabling patients to have an MRI, report and biopsy in one visit, and ensure consistent reporting quality across imaging networks.

CE marking allows Pi to help radiologists assess and report MRI imaging studies, support the decision whether or not to biopsy, and accurately target biopsies where needed. Prostate cancer is the most common cancer in men in Europe, Africa and North and South America, with 1.4 million diagnosed worldwide each year and 375,000 deaths. Earlier detection can help reduce rates of advanced and metastatic disease and in turn greatly improve patients’ experience, outcomes, and life expectancy.

Lucida Medical’s Prostate Intelligence technology uses radiogenomics, machine learning and image processing to analyse magnetic resonance imaging (MRI) scans. Results presented at the European Congress of Radiology (ECR) in March 2021 indicate that it can help automate labour-intensive tasks such as marking out lesions, and avoid unnecessary invasive biopsies, with unprecedented accuracy and consistency.

MRI is now the preferred technique to assess a range of cancers, including prostate and metastatic disease. However, the current process of radiologists interpreting oncological MRI requires specialist training and is labour-intensive, creating a growing skills challenge. The shortfall in the UK radiologist workforce is forecast to reach 43% by 2024.

Prostate cancer diagnosis using MRI represents a major step forward compared to earlier methods but remains prone to human error. The PROMIS study indicated that radiologists can miss 12% of significant cancers on MRI, and lead to 55% of individuals without significant cancer receiving a painful and costly biopsy. The study presented at ECR 2021 suggests that Lucida Medical’s AI technology could help cut missed cancers to 7% and unnecessary biopsies to 24%, as well as making the process faster.

Co-founder and chief medical officer Prof Evis Sala, professor of oncological imaging at the University of Cambridge, said: “We are tremendously excited about this system and its potential to enhance our ability to detect cancer accurately and early. Now PI has CE marking, we can look forward to working with hospitals and radiology and urology partners to bring it into clinical use. COVID-19 has created a serious backlog in cancer screening and Lucida Medical is well placed to help us clear this and further improve the care that we offer over the coming years.”

Dr Antony Rix, CEO and co-founder, added: “Today, about half of cancers are found when they have already spread and this makes them difficult and costly to treat. Our unique approach could allow patients to get exactly the tests, diagnosis and treatment that they need. With around 20 million new cases of cancer diagnosed each year worldwide, there is enormous potential for us to improve patients’ outcomes and reduce costs for health systems like the NHS.”