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New Clinical Data Research Confirms Medial EarlySign’s Machine Learning Platform Can Identify Patients at High-Risk for Colorectal Cancer

Date

October 2, 2017

Results of First US-Based clinical data study of Company’s Risk Stratification Model Reveals Significant Odds Ratio Between ColonFlagTM and CRC Diagnosis

 

KFAR MALAL, Israel – October 2, 2017 – Medial EarlySign (www.earlysign.com), a developer of machine learning tools for data-driven medicine, today announced the results of new research in collaboration with a top integrated health care delivery system in the United States.  The study confirms the efficacy of Medial EarlySign’s ColonFlagTM tool in identifying individuals with 10 times higher risk of harboring undiagnosed colorectal cancer (CRC) while still at curable stages. In many patients, ColonFlagTM was further able to identify risk for colorectal tumors up to 360 days earlier than its actual diagnosis using conventional practices.

 

The peer-reviewed study, Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data, published in Digestive Diseases and Sciences, sought to validate a machine learning risk stratification model for CRC, a lower GI malignancy, on a US-based adult population. It follows successful studies conducted in Israel and the United Kingdom.

 

The analysis was based on data collected from blood samples and demographic information from 17,095 Kaiser Permanente Northwest patients, including a random sample of 900 CRC patients. ColonFlagTM analyzed patients’ complete blood count (CBC) results and factored in age and gender to create a CRC risk score for stratification of each patient.

 

“Colorectal cancer is the second-highest cause of all cancer-related deaths in the USA, responsible for 49,190 deaths in 2016 alone,” said Mark C. Hornbrook, PhD, retired Chief Scientist of Kaiser Permanente Center for Health Research. “Early screening for CRC significantly improves the survival rate. The ability to identify people at high risk for colon cancer and refer them for further testing could help to reduce mortality and prove integral to reducing the overall CRC burden.”

 

This study is the first in the U.S. that utilizes ColonFlagTM to identify individuals at increased risk of having CRC, based on demographics and existing lab test results. CRC cases identified by ColonFlagTM were compared with those detected by low hemoglobin (Hgb) levels alone in two adjacent time windows – 0-180, and 181-360 days prior to diagnosis. For the 0-180-day window, ColonFlagTM demonstrated a 34% and 36% improvement in identifying CRC cases, compared to low Hgb levels for the 50-75 and 40-89-year-old age groups, respectively. In the 181-360-day window, ColonFlagTM detection was 47% higher for the 50-75-year age group, and 84% higher for the 40-89-year-old group.

 

Further analysis revealed that ColonFlagTM performed best in detecting CRC tumors in the cecum and ascending colon. The odds ratio for detecting CRC in the cecum was 93.4 at 99% specificity level. The odds ratios for detection in the ascending colon were 40.3 at 95% specificity and 28.0 at 90% specificity.

 

“Colonoscopy resources are limited, and screening programs are being challenged by the need for active participation of asymptomatic individuals,” said Dr. Ran Goshen, Chief Medical Officer of Medial EarlySign. “ColonFlag’s ability to passively identify those at high-risk among non-participating individuals 180–360 days prior to diagnosis may allow healthcare providers to better allocate colonoscopy resources.”

 

View the full study here.

 

ColonFlagTM is not cleared by the FDA for commercial use in the USA.

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