ColoDix Disruptive and high accuracy test for early colorectal cancer detection in blood

Summary

AMADIX is a leading molecular diagnostics company, led by Rocío Arroyo, focused on liquid biopsy, developing innovative diagnostic tests for early cancer detection in blood. Colorectal cancer (CRC) is the 2nd leading cause of cancer-related deaths worldwide. Most of these cancers and deaths could have been prevented by increasing the use of recommended screening tests that detect premalignant lesions, called advanced adenomas. Colonoscopy is the gold standard screening method, although it is an invasive and expensive procedure.
AMADIX has previously developed an innovative blood-based test for CRC diagnosis (ColoFast), based on an initial combination of cutting-edge biomarkers (micro-RNAs) and validated in +1,000 samples. Indicated to screen healthy population from 50 to 85 years old,has shown superior performance in early cancer detection than any of the tests commercialized, better compliance and cost-effectiveness and is being validated in a European prospective study with 3,100 patients (recruitment concluded) granted by SME Phase 2 with €2.8M. AMADIX has identified new promising biomarkers to be incorporated to the initial signature, to improve the diagnostic performance. AMADIX has taken advantage of the potential of Artificial Intelligence and Big Data to identify CRC risk factors from the patients’ clinical records and develop diagnostic prediction models. Our goal is to validate this new signature, ColoDix, more accurate than the initial combination, based on different types of biomarkers, followed by its commercialization as LDT and as IVD kit. In addition, a risk factors-based algorithm will be incorporated, enabling to predict and identify individuals with a high risk of developing CRC or premalignant polyps, even if they are younger than 50 years old, improving their survival consequently. AMADIX expects to reach between 2023-2032 accumulated revenues of €1,997M from the commercialization of ColoDix in Europe and USA.

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Web resources:	https://cordis.europa.eu/project/id/190177779
Start date:	01-08-2022
End date:	31-03-2025
Total budget - Public funding:	3 567 954,55 Euro - 2 497 568,00 Euro

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Original description

AMADIX is a leading molecular diagnostics company, led by Rocío Arroyo, focused on liquid biopsy, developing innovative diagnostic tests for early cancer detection in blood. Colorectal cancer (CRC) is the 2nd leading cause of cancer-related deaths worldwide. Most of these cancers and deaths could have been prevented by increasing the use of recommended screening tests that detect premalignant lesions, called advanced adenomas. Colonoscopy is the gold standard screening method, although it is an invasive and expensive procedure.
AMADIX has previously developed an innovative blood-based test for CRC diagnosis (ColoFast), based on an initial combination of cutting-edge biomarkers (micro-RNAs) and validated in +1,000 samples. Indicated to screen healthy population from 50 to 85 years old,has shown superior performance in early cancer detection than any of the tests commercialized, better compliance and cost-effectiveness and is being validated in a European prospective study with 3,100 patients (recruitment concluded) granted by SME Phase 2 with €2.8M. AMADIX has identified new promising biomarkers to be incorporated to the initial signature, to improve the diagnostic performance. AMADIX has taken advantage of the potential of Artificial Intelligence and Big Data to identify CRC risk factors from the patients’ clinical records and develop diagnostic prediction models. Our goal is to validate this new signature, PreveCol, more accurate than the initial combination, based on different types of biomarkers, followed by its commercialization as LDT and as IVD kit. In addition, a risk factors-based algorithm will be incorporated, enabling to predict and identify individuals with a high risk of developing CRC or premalignant polyps, even if they are younger than 50 years old, improving their survival consequently. AMADIX expects to reach between 2023-2032 accumulated revenues of €1,997M from the commercialization of PreveCol in Europe and USA.