PreveCol® Test

Prevention of colorectal cancer

Early colon cancer detection

Innovative blood-based test PreveCol®

Why should you get a PreveCol® done?

  1. Colorectal cancer is a silent disease. You can have it and not know it because it does not show symptoms until advanced stages.
  2. It is considered the world’ssecond leading cause of cancer death in both sexes (1).
  3. Cases are increasing this year, in Spain, it is estimated that it will be the most frequently diagnosed cancer with 42,721 new cases (2).
  4. One in 23 men is at risk of suffering from it during their lifetime and 1 in 26 women (3).
  5. Prevention and early detection can increase 5-year survival from 14% to 90% (1).
  6. With just a blood sample we can obtain the result. The test is innovative and non-invasive.

What does it involve?

Amadix will put you in contact with a specialist physician who will give you recommendations regarding the PreveCol® test via a video consultation.

Once you have completed the video consultation, you will be directed to the nearest extraction center where you will need to go to have a 10 ml sample of peripheral blood drawn.

NO preparation is required.

NO fasting is required.

After a few days the specialist physician will receive the results and will share them with you, via video consultation.

More information

  1. Colon and rectal cancer represent the second leading cause of cancer deaths in Spain and it is the most frequent malignant tumour if we take into account the whole population.
  1. It is a silent disease that generally shows no symptoms until the tumour has developed; otherwise, these symptoms can easily be confused with other benign intestinal disorders of minor importance.
  1. Colorectal cancer can be diagnosed early, which greatly increases the prospects of healing.
  1. Most colorectal cancers develop on premalignant lesions (polyps) 10-15 years before the onset of cancer.
  1. Through an early diagnostic test, colorectal cancer can not only be detected, but also prevented, as we can locate and remove polyps (pre-cancerous lesions) before they become malignant.
  1. Early diagnosis reduces mortality by more than 50%.
  1. Survival depends on the stage at which the tumour is detected, so early detection is crucial. For example, when detected in the early stages, the 5-year survival rate is over 90%.
  1. Up to 60% of deaths from colorectal cancer could be avoided with an appropriate screening or early detection programme. However, according to the Spanish Association Against Cancer, only 49.2% of the adult population invited to screening programmes are willing to undergo the available tests.

PreveCol® is an innovative blood-based test for the early detection of colorectal cancer (CRC) or advanced adenomas (AA) and precancerous lesions. It is based on an algorithm that combines the clinical characteristics with the analysis of biomarker levels present in blood.

Yes.

PreveCol® helps to detect precancerous lesions (i.e. advanced adenomas or polyps). In fact, most colon cancers develop slowly over several years. However, before the cancer appears, it is common for a polyp or non-cancerous growth to develop in the inner lining of the colon or rectum. Advanced adenomas are polyps with a high potential for malignancy. Early detection of these polyps through a test such as PreveCol®, and their subsequent removal by colonoscopy, can prevent colorectal cancer.

In addition, early detection of early-stage cancer can improve prognosis and patient survival significantly.

This is why we say that PreveCol® is an effective test for detecting precancerous lesions and early stages of cancer, even when there are no symptoms yet.

PreveCol® is:

  • Innovative
  • Easy for the person
  • Carried out on a blood sample
  • Simple as it does not require any preparation or fasting
  • Disruptive
  • Effective
  • Efficient

After completing the video consultation with a specialist physician, your blood sample will be drawn and sent to our laboratory where the biomarkers will be analysed. Thanks to our innovative algorithm, which also includes clinical factors relating to the individual, a report will be generated with the result that will be sent to the physician and they will inform you of the result during a second video consultation.

The PreveCol® results report will indicate whether the test was positive or negative. These results must be interpreted together with the medical history in the general context of a medical consultation, which must be conducted by a specialist physician.

 

The PreveCol® test result is not a substitute for neither a diagnosis nor the medical advice given by a specialist physician in the context of a medical consultation. Appropriate follow-up by a medical specialist is essential.

A negative result indicates the likely absence of colorectal cancer and/or advanced adenomas (precancerous lesions). In this case it is recommended to continue participating in early detection programmes for colorectal cancer.

A positive result indicates the likely presence of colorectal cancer and/or advanced adenomas (precancerous lesions). It is recommended to give confirmation and complete follow-up of the client using a diagnostic colonoscopy.

The PreveCol® test result is not a substitute for neither a diagnosis nor the medical advice given by a specialist physician in the context of a medical consultation. Appropriate follow-up by a medical specialist is essential.

When the result is negative, the probability that the client is truly healthy is 99.9%.

PreveCol® is a test for the early detection of colorectal cancer and/or advanced adenomas (pre-cancerous lesions) in asymptomatic populations, for both men and women, who are 50-75 years old.

PreveCol® does not currently have clinical data for patients under 50 or over 75 years of age.

However, you can carry out the PreveCol® test if you wish, although it would be out of indication, and this would be reflected in the results report.

PreveCol® currently has no clinical data for patients with a first-degree family history (parents and/or siblings) of colorectal cancer or hereditary colorectal cancer syndrome.

However, you can carry out the PreveCol® test if you wish, although it would be out of indication, and this would be reflected in the results report.

If the family history is second or third degree (neither parents nor siblings), it can be carried out without out of indication messages, as PreveCol® has been approved for this type of population.

PreveCol® does not currently have data for patients with a previous clinical history of colorectal cancer, colorectal adenoma, colorectal polyp in the last 5 years. Or inflammatory bowel disease, Lynch syndrome or familial adenomatous polyposis.

However, you can carry out the PreveCol® test if you wish, although it would be out of indication, and this would be reflected in the results report.

Current colorectal cancer screening programmes in Spain target men and women aged between 50-69.

PreveCol® can be performed in this age range, and also goes beyond the screening population, as it has been studied and approved for men and women between 50 and 75 years of age. This broadens the possibility of screening in a population where the incidence is high.  

PreveCol® included patients aged between 50 and 75 years in its clinical studies.

However, you can carry out the PreveCol® test if you wish, although it would be out of indication, and this would be reflected in the results report.

The PreveCol® Software obtained the CE marking based on Directive 98/79/EC in May 2022, allowing it to be marketed throughout the European Union. In addition, Amadix obtained in March 2022 the Prior Facility Operating License of medical devices from the Spanish Agency for Medicines and Medical Devices (AEMPS).

We are in the process of applying for a marketing authorisation from the US Food and Drug Administration (FDA). In this current moment, PreveCol® is only available in Spain.

PreveCol® is not currently reimbursed by the National Health System.

PreveCol® is not currently included in any health insurance policy, but we recommend that you speak directly to your health insurance company for more specific information.

For more information about PreveCol®, please ask your specialist physician.

Additional information can be found at www.amadix.com

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