The new generation of simple and effective blood test

colox novigenix

An innovative molecular test

Colox® is a new generation blood-based test for early detection of
colorectal cancer. 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.

Based on the principle of host-tumor interaction

Colox® is a molecular test that measures the immune system response to colorectal lesions. The test 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”. 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. RNA markers, chanfed during the initial stages of the development of a lesion, allow for its early detection. The protein tumor markers ensure specificity. 

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 test.

Clinical validation and scientific data

A clinically validated test

Colox is clinically validated and currently available through clinical laboratories in Switzerland. Colox® has been validated through a multi-center clinical study in Switzerland including 782 people. 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.

Clinical validation study

The performance of Colox has been validated in a multicenter clinical study in Switzerland comprising 782 people :
Colox detected 78% of patients with colon cancer with a specificity of 92.2%.
Colox detected 52% of patients with adenomatous polyps with a specificity of 92.2%.
Less than 1 out of 10 people were tested positive when they did not have colon cancer or adenomatous polyps.

Product Sample Sensitivity Specificity
Adenomatous polyps > 1cm
Colox® Blood 52.3% 92.2%
FIT (OC-sensor, 100ng/ml) Stool 23,7 – 27,9% 94,4 – 97,0%
gFOBT (Hemoccult II) Stool 6,8% 95,2%
Colorectal cancer (all stages)
Colox® Blood 78,1% 92,2%
FIT (OC-sensor, 100ng/ml) Stool 69,2 – 75,0% 93,4 – 95,0%
gFOBT (Hemoccult II) Stool 33% 95,2%

Observational study

In 2016, Novigenix launched PROSPEROS : a PROSPEctive and Retrospective Observational Study describing the post-market use and results of the colorectal cancer screening test Colox® in Swiss routine medical practice. It was conducted with 30 doctors and 432 patients. This study highlighted an increase in the detection of cancers and adenomas.

Discover our scientific publications

Indication and Interpretation

Indication

Colox®  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.

Colox® does not require any special preparation.  The test can be done at the same time as other blood tests during an annual medical check-up.

Results

Timeline