Optellum receives FDA clearance for Virtual Nodule Clinic
DART partner Optellum receives FDA clearance for the world’s first AI-powered clinical decision support software for early lung cancer diagnosis
Virtual Nodule Clinic empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the United States.
DART partner Optellum, a lung health company aiming to redefine early diagnosis and treatment of lung disease, has received clearance from the FDA for its Virtual Nodule Clinic.
This revolutionary product is an AI-powered clinical decision support software for pulmonologists and radiologists managing patients with small lesions in the lungs – nodules – that could represent early-stage lung cancer. This is the first such application of AI decision support for early lung cancer diagnosis cleared by the FDA.
Lung cancer kills more people than any other cancer. The current five-year survival rate is an abysmal 20%, primarily due to the majority of patients being diagnosed after symptoms have appeared and the disease has progressed to an advanced stage (Stage III or IV).
By comparison, the survival rate for small tumours treated at Stage IA is up to 90%.
“This clearance will ensure clinicians have the clinical decision support they need to diagnose and treat lung cancer at the earliest possible stage, harnessing the power of physicians and AI working together – to the benefit of patients. Our goal at Optellum is to redefine early diagnosis and treatment of lung cancer, and this FDA clearance is the first step on that journey. We look forward to empowering clinicians in every hospital, from our current customers at academic medical centres to local community hospitals, to offer patients with lung cancer and other deadly lung diseases the most optimal diagnosis and treatment.”
Optellum’s CEO Václav Potěšil
Up to two million US patients a year are identified as having lung nodules through chest CT scans. Current guidelines mandate follow-up over one to two years to determine whether a nodule is cancerous. However, over 60% of these patients do not receive guideline-recommended follow-ups, severely limiting opportunities for early intervention and treatment. Patients who do receive recommended follow-up often require multiple imaging scans and biopsies, and sometimes unnecessary invasive procedures including surgical biopsies and lung resections, before arriving at a definite diagnosis.
Virtual Nodule Clinic
Optellum’s Virtual Nodule Clinic is designed to solve this problem by enabling pulmonologists to identify and track at-risk patients with suspicious lung nodules and make optimal clinical management decisions for those patients. The software features a clinically validated Lung Cancer Prediction (LCP) score designed to empower clinicians to more accurately and consistently evaluate lung cancer risk and make more optimal clinical decisions that could save more patient lives.
Optellum’s LCP score is powered by the world’s first FDA-cleared imaging AI/”Radiomics”-based digital biomarker for lung cancer. The score is computed from full patterns of 3D pixels in standard images captured by Computed Tomography (CT) scanners, which are already available and the standard of care in every modern hospital.
Physician use of Virtual Nodule Clinic is shown to improve diagnostic accuracy and clinical decision-making. In the clinical study which underpins the FDA clearance, all readers in the study, which included pulmonologists and radiologists of various levels of expertise, from generalists to experts, showed a statistically significant improvement in their accuracy for diagnosing lung nodules when using the Optellum software.
Optellum is a commercial-stage lung health company providing Artificial Intelligence decision support software that assists physicians in early diagnosis and optimal treatment for their patients. The company was founded so that every lung disease patient is diagnosed and treated at the earliest possible stage when chances of cure are the highest. Optellum has headquarters at the Oxford Centre for Innovation in Oxford, United Kingdom and a US office at the Texas Medical Center in Houston, TX.
“Congratulations to all the team at Optellum on the news of the FDA approval for the Virtual Nodule Clinic. This is a huge milestone and is the first FDA approved AI solution for enhancing lung cancer diagnosis. NCIMI look forward to working with the team to further develop Optellum’s solutions for lung health, with impact for the NHS and global patient communities.”
“DART is pleased to have the knowledge and support of Optellum in making a real improvement to the early identification, leading to earlier treatment of lung cancer, which is good news for patients and the NHS”
Professor Fergus Gleeson, DART Chief Investigator
The Optellum Virtual Nodule Clinic AI model is being trialled on Lung Cancer Screening (LCS) data, and an automated workflow is being developed to support implementation into clinical practice.
LCS project objectives
Model development and integration: where the existing algorithm is integrated into the LCS workflow to include automated detection and quantification.
Integration of clinical risk parameters and model calibration for UK lung screening population. The model will be extended by including the clinical risk parameters and Optellum will calibrate the resulting model for the UK LCS population to identify the threshold values entry into the various pathways.
Clinical Data Collection and Prospective Validation: the system developed earlier in the work package will be rolled out to the participating trusts and will undergo prospective clinical and health economic validation for every subsequent screening patient. Roche Diagnostics will work to ensure the enablement of the data models for point-of-care software deployment and utilization.
AI algorithm outputs are being validated using the same trial protocol currently in use for testing Optellum’s algorithm in an incidental pulmonary nodule NHS setting (IDEAL). This will lead to easy adoption into the NHS if the trials are successful.
UKRI announces £11 million funding for DART lung health project
DART (the Integration and Analysis of Data Using Artificial Intelligence to Improve Patient Outcomes with Thoracic Diseases) is the latest project to join the NCIMI programme.
UK Research and Innovation, Cancer Research UK and industry are investing more than £11 million in an Oxford-led artificial intelligence (AI) research programme to improve the diagnosis of lung cancer and other thoracic diseases
Professor Fergus Gleeson at the University of Oxford will lead on a programme of research focusing on accelerating pathways for the earlier diagnosis of lung cancer. Lung cancer is the biggest cause of cancer death in the UK and worldwide, with £307 million/year cost to the NHS in England.
Lung health
The earlier that lung cancer is diagnosed, the more likely that treatment will be successful but currently only 16% patients are diagnosed with the earliest stage of the disease. To address this clinical problem, NHS England is launching a £70 million lung cancer screening pilot programme at 10 sites.
DART
To improve patient care beyond the current screening guidelines, a team of academics from Oxford University, Nottingham University, and Imperial College London; NHS clinicians from Oxford University Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, the Royal Marsden Hospital, the Royal Brompton Hospital, and University College London Hospitals NHS Foundation Trust; and the Roy Castle Lung Cancer Foundation will join forces with three leading industrial partners (Roche Diagnostics, GE Healthcare, Optellum).
Working with the NHS England Lung Health Check programme, clinical, imaging and molecular data will be combined for the first time using AI algorithms with the aim of more accurately and quickly diagnosing and characterising lung cancer with fewer invasive clinical procedures. Algorithms will also be developed to better evaluate risks from comorbidities such as chronic obstructive pulmonary disease (COPD).
In addition, this programme will link to data from primary care to better assess risk in the general population to refine the right at-risk individuals to be selected for screening. It is hoped that this research will define a new set of standards for lung health and cancer screening to increase the number of lung cancers diagnosed at an earlier stage, when treatment is more likely to be successful.
“The novel linking of diagnostic technologies, patient outcomes and biomarkers using AI has the potential to make a real difference to how people with suspected lung cancer are investigated. By differentiating between cancers and non-cancers more accurately based on the initial CT scan and blood tests, we hope to remove the delay and possible harm caused by repeat scans and further invasive tests. If successful, this has the potential to reduce patient anxiety and diagnose cancers earlier to improve survival and save the NHS money.”
This programme builds on the National Consortium of Intelligent Medical Imaging (NCIMI) at the Big Data Institute in Oxford, one of five UK AI Centres of Excellence.
The funding, delivered through UK Research and Innovation’s (UKRI’s) Industrial Strategy Challenge Fund, is part of over £13m government investment in ‘data to early diagnosis and precision medicine’ for the research, development and evaluation of integrated diagnostic solutions. UKRI is also partnering with Cancer Research UK, which is making up to a £3m contribution to the cancer-focused projects. The Oxford-led project is one of six awarded from this competition.
“Our brilliant scientists and researchers are at the forefront of harnessing world-leading technologies, like AI, that will tackle some of the most complex and chronic diseases that we face. We know that one in two people in the UK will be diagnosed with some form of cancer during their lifetime, while Crohn’s disease affects up to 125,000 people across the country. These six cutting-edge projects will improve early diagnosis, create more precise treatments, and crucially, save lives.”
Science Minister, Amanda Solloway MP
“Three industry leaders – Roche, Optellum and GE – have joined their expertise in molecular diagnostics, imaging and AI to help diagnose and treat lung cancer patients at the earliest possible stage. The programme results will be integrated into Optellum’s AI-driven Clinical Decision Support platform that supports physicians in choosing the optimal diagnostic and treatment procedures for the right patient at the right time.”
Dr Timor Kadir, Chief Science & Technology Officer at Optellum Ltd
“We are very pleased to be working with the University of Oxford via the NCIMI project on this important lung health and cancer research. By extending our existing NCIMI data infrastructure and creating innovative AI solutions to spot comorbid pathologies, we aim to help identify lung diseases earlier in the UK.”
Ben Newton, General Manager, Oncology, at GE Healthcare
“We are thrilled with this funding award, because it gives us the opportunity to work towards ground-breaking innovation in early diagnosis and because working in partnership is vital to achieve success in the health system. By bringing together the collective knowledge and expertise of these academic, medical and industry partners, this project has the potential to impact patient care globally through new diagnostic solutions in lung cancer.”
Geoff Twist, Managing Director UK and Ireland and Management Centre European Agents at Roche Diagnostics Ltd
”The majority of our lung cancer patients are diagnosed too late for the disease to be cured. We know that we need to be diagnosing lung cancer at an earlier stage, through screening. This innovative project has the potential to revolutionise lung cancer screening, making it more efficient and most importantly, saving lives. Roy Castle Lung Cancer Foundation is delighted to support this Programme”
Dr Jesme Fox, Medical Director of the Roy Castle Lung Cancer Foundation
“I am delighted that this national multi-site collaborative programme will be led from Oxford by Fergus Gleeson. Involving a world-class team of academics, clinicians, local and global industry, and patient representatives, this research is hugely important for accelerating lung cancer detection.”
Professor Xin Lu, co-Director of the CRUK Oxford Centre and Director of the Oxford Centre for Early Cancer Detection
