Cambridge start-up Lucida Medical gains CE mark for AI software that aids accurate prostate cancer diagnosis

New AI-based software that can improve the process of diagnosing prostate cancer has received a CE mark.

Cambridge start-up Lucida Medical is celebrating the progress of its Prostate Intelligence (Pi) technology, which can now be used across the UK or European healthcare systems.

The company intends to make it commercially available in the UK and EU in the first quarter of 2024.

Prostate cancer is the most common cancer in men, claiming 375,000 lives annually, and is notoriously difficult to diagnose.

MRI scans are the preferred imaging technique for diagnosing prostate cancer, along with a number of other cancers and metastatic diseases. But a key clinical study has shown that 12 per cent of significant prostate cancers are missed by radiologists using MRI, while 55 per cent of patients without significant cancer are referred for painful and costly biopsies.

Data was presented to the European Society for Urogenital Radiology (ESUR) in September showing that Lucida Medical’s Pi software could help cut undetected cancers to six per cent while reducing avoidable biopsies to 43 per cent.

Dr Antony Rix, CEO and co-founder of Lucida Medical, a University of Cambridge spin-out, said: “This CE certification establishes Pi as the leading platform to support prostate cancer diagnosis with MRI, from screening patients at elevated risk, to biopsy, diagnosis and treatment planning.

“As the only AI solution for prostate MRI that integrates automatically with radiologists’ workflows and that has unprecedented accuracy in real-world validation, Pi has enormous potential to improve patients’ outcomes and reduce costs and waiting lists in health systems like the NHS.”

The numbers of radiologists in the UK alone are expected to hit a shortfall of 40 per cent by 2027 - another reason why streamlined, simplified and accurate means of diagnosing cancer are much neeed.

Pi uses artificial intelligence to analyse an MRI scan but is fully integrated into the radiologist’s workflow.

This helps cut time for radiologists, while tackling the challenges of variability and diagnostic accuracy.

The software is intended to assess and report prostate MRI studies by automatically producing 3D segmentations, volumes and risk scores, with the outputs supporting clinicians’ decisions over biopsies and treatments.

There are 1.4 million diagnoses of prostate cancer globally each year. In the US alone, some 288,000 are diagnosed and 35,000 die each year from the disease. Pi is not for sale in the US at this stage.

Data from Prostate Cancer UK shows patients suffer from a postcode lottery in the UK, with 35 per cent of men with prostate cancer in Scotland diagnosed late at stage 4, which leads to debilitating treatment and fewer than half of them survive five years. By contrast, 12.5 per cent are diagnosed at stage 4 in London.

As with all cancers, earlier detection is key to cutting rates of advanced and metastatic disease and improve patients’ experience, outcomes and life expectancy.

Prof Evis Sala, Lucida Medical’s co-founder and chief medical officer, who is chair of radiology at the Università Cattolica del Sacro Cuore and director of the Advanced Radiology Centre at the Policlinico Universitario A Gemelli in Rome, said: “We desperately need to cut waiting times, detect cancer early, and provide patients and clinicians with all the information needed to for optimum treatment.”

Prof Sala, who was professor of oncological imaging at the University of Cambridge and Addenbrooke’s Hospital when Lucida Medical was launched, added: “With this CE mark, the results of our investment in AI and clinical research over the last four years can now be used by doctors to provide the best possible diagnosis for men with suspected prostate cancer.”

The company previously received a CE mark in 2021 for an earlier reporting tool that provided visualisations to radiologists.

Dr Rix told the Cambridge Independent: “Due to the limitations of the Class I certification we had in 2021, it could not provide decision support or calculations. We developed the new product because hospitals want the AI to provide a full set of outputs to help them diagnose prostate cancer.

“The new Class IIb certification under the EU Medical Device Regulation enables the software to provide decision support for prostate cancer patients from screening to treatment.

“It produces accurate risk predictions to assess whether a patient requires biopsy or not, calculates volumes of organs and suspected cancers to save time spent in otherwise painstaking manual measurement, and outputs 3D visualisations to support biopsy and treatment.

“The software makes it easy for radiologists to give clinical teams everything they need to report, assess, biopsy and treat prostate cancer.

“Pi is the only product in its category that can analyse cases automatically, providing scores that can be used to prioritise patients to help manage workload and cut waiting times.”

A large clinical study across six NHS hospitals in England was used to validate the class-leading performance of the software, earning Lucida Medical awards at the British Society for Urogenital Radiology 2023 Conference and the International Cancer Imaging Society 2023 Annual Meeting.

And Dr Rix revealed that the technology behind it could be used to aid diagnosis of other cancers too.

“The software is a platform technology able to create imaging biomarkers and identify lesions in a range of cancers,” he said.

“Lucida Medical has already demonstrated that it can be extended to lung, liver and bone cancers, and plans to secure further regulatory approvals during 2024-25.

“Behind this, Lucida’s unique AI technology makes it possible to train the algorithm to generalise with high accuracy with only hundreds of cases, achieving greater accuracy than competing products trained on as many as 10,000 cases.”

Lucida Medical is due to demonstrate Pi at the Radiological Society of North America (RSNA) 2023 Annual Meeting from November 26-29.

The results of the latest external validation of the software in a scientific session will be presented by Dr Francesco Giganti, associate professor of radiology at University College London.

Lucida Medical is backed by investors including XTX Ventures and Prostate Cancer Research, along with leading radiologists and urologists.

It collaborated with GE HealthCare on the software in 2021 and is now piloting it in the UK, Germany and Italy, while building partnerships with hospitals and vendors across Europe.

Lucida Medical is due to demonstrate Pi at the Radiological Society of North America (RSNA) 2023 Annual Meeting from November 26-29.

The results of the latest external validation of the software in a scientific session will be presented by Dr Francesco Giganti, associate professor of radiology at University College London.

Lucida Medical is backed by investors including XTX Ventures and Prostate Cancer Research, along with leading radiologists and urologists.

It collaborated with GE HealthCare on the software in 2021 and is now piloting it in the UK, Germany and Italy, while building partnerships with hospitals and vendors across Europe.