Colorectal cancer (CRC) is a global danger for both women (the second-most commonly diagnosed form of cancer), and men (the third-most). Screening programs can reduce CRC mortality by as much as 15–30%. The problem is that many patients eligible for CRC screening do not follow through with tests they have been instructed to do.
Medial EarlySign’s Colorectal Cancer model for identification of individuals at high risk of having CRC was developed using data of over 605,000 Maccabi Healthcare Services (MHS) patients aged 40+. MHS is the second largest HMO in Israel, with approximately 2 million patients. Data extraction, model development and analysis were all performed according to an Ethics Committee approved protocol. All patients’ records were anonymized and de-identified prior to analysis. This cohort, which included 3,135 CRC cases, was randomly divided into a derivation (training) dataset (80% of the data) and a separate validation dataset (20% of the data). The model was further validated using de-identified data of 25,613 individuals above age 40 (5,061 CRC cases), from The Health Improvement Network (THIN), a UK primary care database. This database represents an external independent validation set.
The model’s results showed that when MHS used Medial EarlySign’s CRC algorithm in its workflow, primary care physicians alerted patients whose risk scores fell above a risk level pre-determined by the HMO. The sub-population flagged using EarlySign’s CRC algorithm had a higher likelihood for positive CRC findings, which also resulted in downstream medical savings for high-risk patients who received timely care.
The model was further investigated and validated in relation to CRC, advanced adenomas, and precancerous polyps in various clinical data studies in leading medical and health system institutions and CRC screening centers around the world, involving key opinion leaders in gastroenterology and public health. The research study sites are located in Israel, North America (United States and Canada), Europe and Asia, thus representing diverse populations.*
Study designs range from case-control designs to a cohort design of more than 1.5 million individuals.
Learn more: Results of implementation at an HMO.
Learn more: ColonFlag™*
*Disclaimer: ColonFlag™ bears CE designation, but not FDA clearance.
In the U.S., Medial EarlySign received FDA clearance for its Lower GI Flag™ solution.