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Lucida Medical earns CE mark for AI-powered prostate cancer detection software





Cambridge start-up Lucida Medical has received a CE mark for its machine learning-powered prostate cancer detection software Prostate Intelligence (Pi).

The company becomes one of the world’s first to commercialise artificial intelligence software to identify cancer in prostate MRI scans.

Lucida Medical uses AI to help interpret MRI scans
Lucida Medical uses AI to help interpret MRI scans

Prof Evis Sala, co-founder and chief medical officer of Lucida Medical and professor of oncological imaging at the University of Cambridge and Addenbrooke’s Hospital, 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.”

The CE mark means the software is now eligible for use in the NHS and in European healthcare systems.

Prostate cancer is the most common cancer in men across Europe, Africa and North and South America. There are 1.4 million cases diagnosed worldwide each year and 375,000 deaths.

Earlier detection can reduce rates of advanced and metastatic disease and improve patients’ experience, outcomes and life expectancy.

Lucida Medical co-founder and chief medical officer Prof Evis Sala, professor of oncological imaging at the University of Cambridge
Lucida Medical co-founder and chief medical officer Prof Evis Sala, professor of oncological imaging at the University of Cambridge

But diagnosis is not straightforward. It typically begins with a GP taking urine and blood samples and these, along with a digital rectal examination, can highlight if a man is at risk.

Those who are will be sent to hospital to discuss options for further tests.

MRI - magnetic resonance imaging - is now offered on the NHS for diagnosis, and represents a major step forward. But analysing the results remains prone to human error.

A PROMIS study, published in the Lancet in 2017, showed radiologists can miss 12 per cent of significant cancers on MRI, while 55 per cent of individuals without significant cancer can still end up with a painful and costly biopsy.

A study presented at ECR 2021 suggests Lucida Medical’s AI technology could cut the proportion of missed cancers to seven per cent and unnecessary biopsies to 24 per cent, as well as speeding up the process by helping to enable ‘one-stop shop’ diagnosis, in which patients have their MRI, report and biopsy in one visit.

Antony Rix, CEO of Lucida Medical. Picture: Keith Heppell
Antony Rix, CEO of Lucida Medical. Picture: Keith Heppell

Lucida Medical’s technology uses radiogenomics, machine learning and image processing to analyse the scans. It can also automate labour-intensive tasks such as marking out lesions.

CEO and co-founder Dr Antony Rix said: “CE marking, together with the UKCA certification that we have also completed, allows Pi to be used across Europe and the UK. Lucida Medical is now working with leading hospitals and technology partners to integrate the technology.

“I’m absolutely delighted by the rapid progress that our team have made since our investment earlier this year. We’re inspired by clinicians’ tremendous enthusiasm to use this ground-breaking approach to improve the diagnostic process for prostate cancer patients.”

The University of Cambridge spin-out’s technology comes at a time when there is a major skills shortage in interpreting oncological MRI, which requires specialist training.Lucida Medical says the shortfall in the UK radiologist workforce is forecast to reach 43 per cent by 2024.

Lucida Medical’s technology will help radiologists and patients
Lucida Medical’s technology will help radiologists and patients

Professor Anwar Padhani, professor of cancer imaging at the Institute of Cancer Research in London, said the system will be very useful in preventing unnecessary biopsies, while decreasing variations in biopsy yields.

“AI is going to be essential to successfully deploy community-wide MRI-driven prostate cancer diagnosis,” he said

“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”

And Prof Hashim Ahmed, professor of urology at Imperial College, 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.”

In March, Lucida Medical confirmed a “multi-million pound” investment led by XTX Ventures and Prostate Cancer Research.

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