What is PreveCol®?

PreveCol®, an innovative blood-based test for early colorectal cancer detection

What if a simple blood test could tell you who will have cancer in the future?

A simple blood-based test

Product characteristics

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How does it work?

Transforming early cancer diagnosis

PreveCol® is an innovative test based on an algorithm that combines the clinical characteristics identified by Artificial Intelligence with the analysis of biomarker levels in plasma for the early detection of Colorectal Cancer (CRC) and advanced adenoma (AA).

High potential

Superior accuracy

Very simple

No previous preparation



PreveCol® characteristics

Learn more about PreveCol®

An easy and innovative test to detect colorectal cancer in blood.

PreveCol® is indicated to screen adults of either sex, 50 years or older, who are at an average risk for colorectal cancer.
When colon cancer is detected at early localized stages (I-II) the 5-year survival rate is 90% while this rate drops to 12% when patients are diagnosed at stage IV and metastasis. These data show the importance of screening for colon cancer at a treatable stage.


According to the Asociación Española Contra el Cáncer (AECC), well implemented screening programs could reduce cancer mortality rates between 30%-35%.
Yes. PreveCol® helps to find premalignant lesions (i.e., advanced adenomas) or colon cancer. In fact, most colon cancers develop slowly over several years. However, before cancer appears, it is common for a polyp or non-cancerous growth to develop on the inner lining of the colon or rectum. Advanced adenomas are polyps with high potential of malignancy. Finding and removing premalignant lesions through a simple colonoscopy prevents colon cancer whereas detection of early stage improves patient prognosis.

Survival rate when detected in early stages (I-III)

Yes. It is a minimally invasive test that only requires a simple blood extraction. It represents advantages compared to other screening methods, such as those based on direct visualization of the colorectal area, which are risky and could potentially harm the patients, and those that use fecal samples, which have a low compliance mainly due to the difficulty of sample collection.

PreveCol® is self-certified through a declaration of conformity under the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. In order to comply with the applicable requirements of the Directive, ISO 13485:2016, a harmonized standard recognized by the European Commission, is implemented.

Prevecol® has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

When did we obtain the Breakthrough Device designation?

Amadix has obtained Breakthrough Device designation for PreveCol® in December 2023

What is the FDA Breakthrough Device Designation Program?

According to the FDA, the main objective of the Breakthrough Device Designation Program is to provide patients and healthcare professionals with rapid access to disruptive innovative technologies. This program aims to expedite the development, evaluation, and review of these technologies for validation and pre-market approval, without compromising patient safety.

This program reflects FDA’s strong commitment to innovation and protecting public health.

What does it mean?

PreveCol® acquires accelerated and prioritized access in discussions with the FDA during the validation and approval process of the test for its commercialization in the United States.

Why has PreveCol been given this Breakthrough Device designation?

To obtain this distinction, PreveCol® has demonstrated greater effectiveness in the early detection of precancerous lesions of colorectal cancer compared to tests available in the United States, providing a significant benefit for patients.

What does it mean for Amadix and for PreveCol®?

Amadix becomes the first European company to announce the recognition of FDA’s Breakthrough Device designation for early detection of colorectal cancer.

For further information, you can contact us at:

Colorectal cancer (CRC) is the 3rd most frequent tumor and is usually detected in late stages


New cases of CRC in the world 20201





The incidence of cancer in the world will increase by 53,2% in the next 20 years1

1 Globocan 2020 Colorectal Cancer fact sheet

Developing IA algorithms for early cancer diagnosis

Aligned with our mission, we are working on combining our blood-based test using molecular biomarkers with colon cancer risk factors identified by Artificial Intelligence and Big Data tools, based on medical history and individual habits.

We continue to go further and are exploring the infinite possibilities that clinical records and patient lifestyle data offer through the latest Artificial Intelligence (AI) and Advanced Data Analytical Tools. This will allow us to identify new risk factors to develop predictive models which will help us anticipate hidden underlying cancer risk factors and help improve the quality of life and survival of cancer patients.

Artificial Intelligence (AI) and Advanced Data Analytical tools will serve AMADIX to identify hidden underlying cancer risk factors and develop predictive models to include in PreveCol® algorithms, as well as define new screening populations, in which the eligibility criterion is not based solely on age.

International Patents

Solid intellectual property protection

PreveCol® is protected by different worldwide patents. The patent protection relates to the field of colorectal cancer and advanced adenoma detection.


All about Cancer

Unmet Need

Current existing colorectal cancer screening methods, such as colonoscopy and fecal-based tests have limitations. Today, there is a significant clinical need that remains unmet for blood-based colorectal cancer screening that detects cancer early, accurately, and easily when it is in different stages. The solution developed by AMADIX –an innovative early colorectal cancer detection blood-based test– has high potential and has shown superior accuracy.

Exploring the Data

Amadix continues to go further, not only working at a molecular level but also exploring the infinite possibilities that clinical records and patient lifestyle data offer through the latest Artificial Intelligence (AI) and Advanced Data Analytical Tools, in order to identify new risk factors to develop predictive models which will help us anticipate hidden and underlying cancer risk factors and help improve the quality of life and survival of cancer patients.

Personalized and precision medicine

Specific information about the patient’s tumor is used to improve a cancer diagnosis, plan a therapy, determine whether a treatment is suitable for that specific individual or not, and give a prognosis. In personalized medicine, specific biomarkers are used for identifying a given disease or disorder.

Do you want to request a test?

If you are a patient, please ask your physician how to get Prevecol® or tell them to contact us.

If you are a doctor, fill in this form to contact us and/or to request a test

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