Clinical adoption of AI-based products in lung cancer screening: barriers to market entry, and a comparative, multi-center, cross-European study. 

Lung Cancer is the second most common type of cancer and the number one cause of cancer death. The majority of patients diagnosed with lung cancer are already in the late stages and, therefore, have a poor prognosis with a five-year survival rate of only 10–20%. Diagnosing lung cancer at an early stage, before the cancer has metastasized, could increase the chance of providing effective treatment earlier and the survival rates dramatically. Two large RCTs have clinically proven that annual screening of the risk population through Low-dose CT (LDCT) reduces mortality by approximately 20%; the US-based, NCI-initiated NLST study and the European NELSON study, initiated by i-DNA, a Dutch research organization, dedicated to early detection of lung cancer. This positioned i-DNA and their scientific leader, Professor Matthijs Oudkerk, as the leading global group in the field. Based on these two studies, the use of LDCT has been recommended by health organizations worldwide. Countries throughout the world have begun to either adopt screening programs or are in screening programs pilots, like the Israeli Ministry of Health TIGAR program.  

One of the hurdles to the full adoption of the screening programs is the radiologist’s bottleneck, which is severe and only aggravating worldwide. Screening of lung cancer requires the interpreting radiologist to go over several hundreds of slides in the chest CT scan and detect each cancer suspicious “Lung nodule” – tiny objects the size of several millimeters, with the characteristics of probability of developing into cancerous tumors. This tedious work consumes a lot of time and effort and is subject to inter and intra-observer variability as well as human error. 

Given all these factors, the need for using AI-based tools to detect and manage lung nodules is clear. Indeed, there are publications confirming the good performance of AI in the detection, segmentation, and classification of nodules, and in LCS, AI as an impartial reader exceeds radiologists in negative misclassification results and reduces workload by up to 86.7%. And still, despite the clear need and the promising results, real clinical implementation is rare. Therefore, i-DNA, as the leading global organization promoting the implementation of screening programs, has initiated a new strategic project. Recognizing the barriers to adoption as the limited clinical evidence, lack of multi-center studies, and limited cost-effectiveness data, resulting majorly from the technological limits current AI technologies are bound to, as well as the need to create a benchmark of AI solutions to empower purchasers to make better-informed decisions, they have created a large comparative study between the leading AI models in the world. The project involves the two most important screening programs in Europe, 4ITLR and UKLS, with data gathered from leading medical centers in 8 countries. The project aims to generate the exact needed clinical and economic data to allow real implementation of AI technology in LCS and in the radiologists’ real-life clinical workflow. 

Genesis Medical Vision is an Israeli company developing an early detection of cancer AI platform. The company is pioneering deep IIMM technology, a completely new and different approach to AI in radiology, which allows the company to imitate and replicate the logic and intuition of physicians and build an algorithm accordingly. Thanks to that unique approach, the company believes it can solve all the technological barriers that have delayed and prevented the adoption of AI technology in the market until now. Genesis has finalized a clinical trial with its first product, the G4Lungs, allowing automated screening of lung cancer together with its design partner Assuta, showing results that facilitate real clinical adoption. The next step is to prove all these claims on a larger scale clinically, in a comparative study, and on the most important stage in the world. 

Genesis has partnered with i-DNA and is participating in this exclusive comparative study, which should pave the way towards the market and real clinical adoption in Europe but also in other strategic markets, such as the US.