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colox2018-07-12T10:54:50+02:00

The new generation blood test : easy and effective 

colox novigenix

Early detection saves lives

Our solution

Colox® is a a new generation blood-based test for early detection of colorectal cancer. It is clinically validated and currently available through clinical laboratories in Switzerland. Colox® has proven to have significant benefits:

  • It accurately and reliably detects both adenomatous polyps and early stages of colorectal cancer,
  • It offers a convenient solution for patients to be tested with no need for bowel or stool preparation,
  • It can be ordered by the physician as part of a routine medical check-up.

Colox® has been validated through a multi-center clinical study in Switzerland detecting 78% of colorectal cancer patients, and 52% of patients with adenomatous polyps. Less than 1 out of 10 people without any colorectal lesion tested positive5. Individuals testing positive with Colox® have high probability to present colorectal lesions and are referred for follow-up diagnostic colonoscopy for final diagnosis. Individuals testing negative with Colox® have no colorectal lesion with high probability and should continue periodic testing at intervals recommended by their physician.

How does Colox® work?

Colox® is based on the analysis of peripheral blood mononuclear cells (PBMCs) isolated from a routine blood sample. PBMCs are responsive to growing adenomatous polyps and colorectal carcinomas as part of the “host-response”6.

Colox® measures the combined response of gene expression profile of 29 biomarkers by real-time PCR in PBMCs and the concentration of 2 protein tumor markers in plasma. The biomarker measurement data are interpreted by Novigenix’s proprietary algorithm which generates the Colox® test result. This algorithm is based on classifier combinations derived from state-of-the art mathematical analytical methods that underpin the reliability of the test7.

Colox® is available as a laboratory-developed test and is highly adaptable to standard medical laboratory workflows. Colox® is also available as a CE-IVD kit.

How can I be tested with Colox®?

The Colox test can be prescribed by your general practitioner. Print this “Information for doctors” and ask your doctor for advice. The blood sample can be taken at your doctor’s office or at a medical laboratory. The results of the test will be sent to you by your doctor.

Timeline

What you need to know about the Colox® test

Colox® presentation2018-07-12T11:05:13+02:00

> What is Colox® ?
Colox® is an easy and efficient blood test for the detection of colorectal tumours and adenomatous polyps. Colox® is a screening test which identifies the high-risk cases of colorectal cancer and directs patients to a colonoscopy diagnosis when needed.

 

> How does Colox® work ?
Colox® is a molecular test which combines 29 RNA biomarkers with 2 protein tumor markers to give a positive or negative result. RNA markers, changed during the initial stages of the development of a lesion, allow for its early detection. The 2 proteins ensure its specificity. The variation of these biomarkers can signify the presence of a colorectal tumor which will be confirmed thanks to a colonoscopy.

 

Read more : Development and Clinical Validation of a Blood Test Based on 29-Gene Expression for Early Detection of Colorectal Cancer

 

Indications2018-05-14T14:59:26+02:00

> Who can do a Colox® test?
Colox® is a screening test for the prevention and the early detection of colorectal cancer. The test is intended for women and men with an average risk of colorectal cancer: aged 50 and over, no symptom of colorectal cancer, no history of cancer or hereditary syndromes or chronic inflammatory bowel disease.

 

> Who can’t do a Colox® test?
Colox® is not recommended for people who have a higher risk of colorectal cancer than average with:

  • A personal history of adenomatous polyps or colorectal cancer
  • A first-degree family history of colorectal cancer
  • A family and/or personal history of a high-risk hereditary syndrome such as: Lynch syndrome (HNPCC), familial adenomatous polyps (FAP), etc
  • A family and/or personal history of a high risk hereditary syndrome such as: Lynch syndrome (HNPCC), familial adenomatous polyps (FAP), etc
  • A personal history of chronic inflammatory bowel disease (CIBD), Crohn’s disease, haemorrhagic recto colitis (HRC), etc

 

 

The benefits of the Colox® test2018-05-14T14:59:17+02:00

> Why should I choose Colox® ? What are the benefits?
Colox® is the most convenient screening test on the market that enables early diagnosis of colorectal cancer. It just needs a blood test compared to other more invasive and inconvenient tests, which require you to prepare your bowels or handle your stools. Moreover, it doesn’t require a hospital stay. Reliable clinical studies have proved the performance of the test for the effective detection of colorectal cancers. Moreover, Colox® has good performances for the detection of adenomatous polyps bigger than 1cm.
This test is therefore intended for women and men who prefer the simplicity of a blood test to an invasive screening colonoscopy.

 

> Has Colox® already been prescribed?
Colox® is a test used in medical routine. Today, 400 doctors have already prescribed Colox® to more than 3200 patients.

Doing the Colox® test2018-05-14T14:59:08+02:00

> What is the procedure if I want to get screened with Colox®?
First, you have to go to your doctor’s office to talk to him about the test and to know if Colox is recommended for you. Then, a blood sample is taken by the doctor or directly at the laboratory. The laboratory will analyse the sample and then your results will be sent to your doctor. You can also contact Novigenix for more information.

 

> Are there special recommendations before performing the Colox® test?
One of the advantages of Colox is that it does not require any special preparation. However, it is recommended you don’t smoke for 12 hours before the blood test. Some drugs can also influence the results. Ask your doctor for advice.

 

> Should I do a colonoscopy too?
Yes, if the result of the test is positive. A colonoscopy is the gold standard for the diagnosis of colorectal cancer and adenomatous polyps. Moreover, a colonoscopy allows for a direct resection of polyps to thus prevent them from developing into cancer.

 

 

The results of the Colox® test2018-05-14T14:58:53+02:00

> How much time to get the results?
The results will be communicated to your doctor after one to two weeks.

 

> How can I interpret my results?
If your Colox is negative, this means that you have no cancerous colorectal lesion with a probability of 99.9%.
If your result is positive, this means that you have adenomatous polyps with a probability of 52% but only 2% of positive tests will be cancer. A positive result requires a follow-up diagnostic colonoscopy.

 

> After how long do I have to repeat the test?
It is recommended to get screened every two years.

 

> How much does the test cost?
Colox costs CHF 279. Colox is not reimbursed for the moment. Some insurances may cover a part of the cost, ask your insurance directly.

Colox® is currently available through our partners medical laboratories in Switzerland:

Unilabs Lausanne

Rue de la Vigie 5
Tel. 021 321 40 00
Fax. 021 321 40 40
www.unilabs.ch

Labormedizinisches Zentrum Dr Risch

Waldeggstrasse 37, 3097 Liebefeld
Tel. 058 523 34 00
Fax.058 523 34 99
www.risch.ch

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