EIT Health-supported Optellum attains CE mark

EIT Health-supported start-up, Optellum, headquartered in Oxford, UK, has attained a CE mark for its innovative solution which supports the precision diagnosis of lung cancer in its earliest stages. Their technology, the Virtual Nodule Clinic, is an AI-powered decision support software for lung cancer diagnosis, the first such system to achieve clearance under CE-Medical Device Regulation (MDR).

The newly CE-marked technology enables early intervention, allowing doctors to treat patients while the disease is still in its early stages and curable. Ultimately this promises to improve patient outcomes and increase lung cancer survival rates.

Lung cancer is the leading cause of cancer deaths in Europe, causing around 380,000 deaths (20% of all cancer deaths).[1] When diagnosed at its earliest stage, almost 90% of people with lung cancer will survive their disease for five years or more, compared with only 5% when the disease is diagnosed at the latest stage.[2]

EIT Health is proud to have supported Optellum in their development journey. With funding provided through EIT Health, Innovate UK, the NHS AI Lab and the National Institute for Health Research (NIHR) partnerships, Optellum’s machine-learning scientists and engineers used computed tomography (CT) images to train a machine-learning neural network to recognise the early signs of lung cancer.

The outcome of this work was the Optellum Virtual Nodule Clinic that helps clinicians identify, track and optimally manage patients with suspicious lung lesions detected in lung cancer screening and chest CTs acquired for other reasons, such as cardiac and emergency room scans.

The solution integrates the clinically validated Lung Cancer Prediction (LCP) score, a digital biomarker based on imaging AI or “radiomics”. Its goal is to speed up the start of lung cancer treatment, while reducing aggressive procedures, such as biopsies on benign lesions.

The Optellum technology was developed and clinically validated in partnership with leading hospitals across the USA, UK and EU, including EIT Health partners Oxford University Hospital, Heidelberg University and the University of Groningen. It has the potential to revolutionise how lung cancer is diagnosed and treated.

Last year, Optellum marked a world’s-first in achieving FDA clearance for the application of AI decision support in lung cancer diagnosis. The solution has already been implemented commercially by leading US medical centres including the The Vanderbilt Lung Institute, University of Mississippi Medical Center, and Wake Forest Baptist Health.

Following this success, Optellum began a strategic partnership with EIT Health partner, GE Healthcare, to accelerate global deployments and advance precision diagnosis and treatment of lung cancer.

“We’re delighted to see Optellum attain a CE mark for their solution to support the early diagnosis and treatment of lung cancer, the leading cause of cancer deaths in Europe. Not only does early treatment have a better success rate, but it is also more affordable and offers the patient a better quality of life,” says Jean-Marc Bourez, CEO ad interim, EIT Health.

Dr. Václav Potěšil, Founder and Chief Business Officer of Optellum, said of the recent achievement:  “This latest certification opens the door to provide Optellum’s solution to clinicians in key markets across Europe enabling them to provide their patients with personalised diagnosis and the best possible treatment outcomes.”

Commenting on the pivotal role EIT Health has played in Optellum’s journey, Dr Potěšil noted:  “Optellum has benefited tremendously from the support of the entrepreneurial EIT Health team. Starting with the first external funding through EIT Health grants, which helped us raise initial VC funding in 2017 and get Optellum off the ground, through to becoming the leader in AI-powered lung cancer diagnosis and treatment − benefiting patients across the globe.”