New Machine Learning-based Prostate Cancer Detection Software Receives CE Mark

Lucida Medical Ltd has received CE marking for its new machine learning-based prostate cancer detection software, Prostate Intelligence (Pi). The Cambridge UK based start-up is one of the first companies in the world to commercialize artificial intelligence software to identify cancer in prostate MRI scans.

With the CE marking radiologists can now use Pi to assess and report MR imaging studies, support  the decision whether or not to biopsy, and accurately target biopsies where needed. Lucida Medical’s goal is to significantly improve the prostate cancer diagnostic pathway with technology that finds cancer more accurately by analyzing 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.

Lucida Medical’s Prostate Intelligence™ technology uses radiogenomics, machine learning and image processing to analyze magnetic resonance imaging (MRI) scans. Results presented at the European Congress of Radiology (ECR) in March 2021 indicate that it can help automate labor-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 labor-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 ground-breaking PROMIS study (Lancet 2017; 389: 815–22) 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, said, “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.”

Professor Anwar Padhani, Professor of Cancer Imaging at the Institute of Cancer Research in London said, “AI is going to be essential to successfully deploy community-wide MRI-driven prostate cancer diagnosis. AI system will enable the main benefits of biopsy avoidance are delivered while decreasing the variations in biopsy yields. Initial uses will be to support radiologists’ workflow including gland and target outlining tasks for fusion biopsies. Developing AI systems as clinical decision-making tools requires further efforts. The CE mark enables us to take the next steps.”

Professor Padhani is an internationally recognized Oncological MRI radiologist and the clinical lead in MRI at the Paul Strickland Scanner Centre.

Professor Hashim Ahmed, Professor of Urology at Imperial College, University of London said, “There is tremendous need for an AI decision support system that significantly increases productivity and the quality of MR prostate cancer reporting and the Lucida Medical system shows great promise”

Professor Ahmed was one of the very early users of MRI and transperineal biopsy to diagnose prostate cancer. Further he is a pioneer of focal therapy treatment for prostate cancer. His current trials are focused on the Prostagram, the objective being to have a short MRI scan to screen for prostate cancer in the same way as mammograms are used to screen for breast cancer in women.

Oliver Kemp, CEO of Prostate Cancer Research, said, “Prostate cancer patients deserve the best possible care and to live as full a life as possible. We are delighted that our investment has helped take this exciting technology through regulatory approvals. We are looking forward to seeing the benefits for prostate cancer patients and the NHS.

The software is not for sale in the US.