iBiopsy®: Median Technologies Continues Its Strong Positioning in Early-Stage Diagnosis with a New iBiopsy® Clinical Development Plan on Lung Cancer Screening (LCS)
Regulatory News:
Median Technologies (ALMDT:PA) (Paris:ALMDT) unveils today a new iBiopsy® Clinical Development Plan (CDP) for the diagnosis of early-stage lung cancer in high-risk populations based on Low Dose Computed Tomography (LDCT) scans, strengthening its positioning in early-stage diagnosis, such as early-stage liver cancer diagnosis and non-alcoholic steatohepatitis (NASH) identification.
Lung cancer is today the number one cancer killer globally and is responsible for approximatively 22% of cancer deaths1. The 5-year survival rate for lung cancer is only 18,6%2 because the majority of lung cancers are diagnosed late in the disease, when cure is no longer possible. In the past years, a significant number of clinical trials on very large patient cohorts have been conducted to determine the impact of diagnosing lung cancer at an early stage on lung cancer mortality. Results from these multicentric randomized trials have shown that lung cancer screening using LDCT reduces lung cancer mortality by 20–26% in high-risk populations3. In the US, LDCT lung cancer screening for high-risk individuals is included in the United States Preventive Services Task Force (USPSTF) screening guidelines and reimbursed by CMS4. Lung cancer screening programs are under discussion to be implemented in Europe. In France, the recently announced 2021-2030 Cancer Plan includes new measures for the early diagnosis of cancers associated with poor prognosis (5-year survival rate < 20%) including lung cancer5.
Deep learning models have the potential to significantly increase the accuracy, consistency and adoption of lung cancer screening worldwide through rapid diagnosis support, risk stratification and reduced need for costly and invasive interventions (biopsies, resections). Median will use its iBiopsy® platform to develop AI-based algorithms enabling the identification and characterization (i.e., discrimination between malignant and benign) of lesions in thoracic LDCT images, decreasing the number of false positives and overdiagnosis.
Median has been working for many months on a LCS solution and will benefit from its years of experience and knowledge in the domain as well as of its existing relationships with some of the leading clinical sites in the world. Median has already collected over 17,000 cases of LCS from multiple databases and is currently curating and annotating a preliminary set of 1,800 data to train and validate its algorithms. The company expects to deliver a proof of concept in H2, 2021 based on this subset.
“Many cancers don’t kill if diagnosed early and AI technologies are the cornerstone to deliver early diagnosis in a very accurate manner, increase cancer screening adoption globally and save patients’ lives from these pathologies”, said Fredrik Brag, CEO and Founder of Median. “Based on the NELSON criteria, more than 34m people are considered at risk for lung cancer in Europe and it is almost the same number in the US. The medico-economic impact of diagnosing early lung cancer could be very significant for patients and payers. The lung cancer screening market is estimated to be between $5b-20bn depending on level of reimbursement for the diagnostic test,” he added.
About iBiopsy®
iBiopsy® is based on the most advanced technologies in Artificial Intelligence (AI), benefiting from Median’s expertise in Data Science and medical image processing. iBiopsy® targets the development of non-invasive image-based diagnosis tesrs, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. Several indications are already targeted: liver diseases (NASH and HCC), predicting the efficacy of immuno-oncology drugs and early diagnosis of lung cancer in high-risk populations.
Median’s iBiopsy® development program is supported by the European Investment Bank (EIB) through a financial loan of €35 million under the Juncker Plan, the European Fund for Strategic Investments, which aims to support research and innovation projects developed by companies with high growth potential.
About Median Technologies: Median Technologies provides innovative imaging solutions and services to advance healthcare for everyone. We leverage the power of Imaging Phenomics to provide insights into novel therapies and treatment strategies. Our unique solutions for medical image analysis and management in oncology trials and iBiopsy® for imaging phenotyping, together with our global team of experts, are advancing the development of new drugs and diagnostic tools to monitor disease and assess response to therapy. Median Technologies supports biopharmaceutical sponsors and healthcare professionals around the world to quickly and precisely bring new treatments to patients in need. This is how we are helping to create a healthier world.
Founded in 2002, based in Sophia-Antipolis, France, with a subsidiary in the US and another one in Shanghai, Median has received the label “Innovative company” by the BPI and is listed on the Euronext Growth market. FR0011049824– ticker: ALMDT. Median is eligible for the French SME equity savings plan scheme (PEA-PME), listed on the Enternext® PEA-PME 150 index and has been awarded the Euronext European Rising Tech label. For more information: www.mediantechnologies.com
1 https://www.who.int/news-room/fact-sheets/detail/cancer
2 https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet
3 Results from NLSC, NELSON, SUMMIT initiatives
4 https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274
5 https://www.e-cancer.fr/Institut-national-du-cancer/Strategie-de-lutte-contre-les-cancers-en-France/La-strategie-decennale-de-lutte-contre-les-cancers-2021-2030/Le-lancement-de-la-strategie
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