CNI Explanation

Chronix Biomedical has now made available a laboratory developed test for the detection of risk factors highly associated with cancer. We know today that cancer – in a large number of cases – is characterized by strong changes in the DNA. Cancer cell DNA differs from all other normal cells of the body. This difference can be detected with modern laboratory procedures.


Through the simple process of drawing blood, we can now offer a test that can, with a high degree of accuracy, detect macromolecular mutations of DNA fragments in blood plasma, which are closely associated with cancer. This blood test is a new measure that can help in the early detection of cancer. However, the test is not intended to replace the regular preventive examinations, which you should continue to use.


Our assay will calculate a measured value based on the 16 ml blood sample you provide. If the measured value is within the limits of what we find in healthy people, there is no evidence in the sample of a cancer at that point in time. If the first result shows a higher value, we will recommend further diagnostic measures to your doctor.


With this test, it is possible to detect some cancers before they are noticed by symptoms. Once confirmed, a therapy can then be initiated at an earlier stage than before. Some cancers may not be detectable by our blood test, so a negative result does not exclude a cancer with certainty. It is also possible that no cancer can be found despite the increased measured value.

What is cancer?

Advanced Cancer DiagnosticsCancer is a disease in which genetic mutation in the base (genomic) DNA of an individual leads to a disruption of the normal checks and balances (homeostasis) of the body, in which cell multiplication is matched closely to the body’s needs. The cancer cell (clone) has lost the ability to respond to homoeostatic needs and continues to divide out with the body’s needs, and relentlessly, in one or multiple (metastatic) sites – driven by positive (oncogene) or lack of negative (suppressor gene) influences.

Advanced Cancer DiagnosticsThese mutations in the already developed tissue/organ (somatic) cells lead to cancer (e.g. breast, lung, colon) and in the overwhelming majority are of adult cancers this follows after the accumulation of multiple mutations. Many of the mutations occur in single DNA base pairs, but, interestingly, it has recently been appreciated that, and associated with these mutations (perhaps due to defective DNA repair mechanisms), there are amplifications and/or losses of large sequences of genetic material associated with these mutations (these being further mutations themselves).

See a video showing how our technology works

What is NGS (Next Generation Sequencing)?

Advanced Cancer DiagnosticsNext Generation Sequencing (NGS) is the method which allowed scientists to determine the sequence of the whole human Genome, and such DNA “mapping” can now be performed on circulating cell DNA in the blood – either from circulating (e.g. white – blood) cells or cell-free DNA (cfDNA), derived from dying (“turning-over”) cells – indeed such cfDNA is always entering the bloodstream, with a turnover half life of some minutes, before the body digests and recycles the constituents. What has recently been appreciated is that this last statement applies to cancer – fragments of cancer cfDNA are constantly entering the bloodstream, are detectable by NGS and can be differentiated from normal DNA by the mutational “fingerprint” – best detected by the ‘defining’ gains and losses (DNA Copy Number Instability score – CNI).


Indeed, assessment of CNI may be the best test for determining the presence of cancer, the best test for determining whether treatments such as surgery have achieved a cure of a cancer and whether a past cancer is returning – by serial testing at intervals. More research on the cfDNA may allow us to determine the tissue of origin of the cancer e.g. prostate versus lung cancer, and for following the mutational evolution of a cancer- for cancer cells are mutating unceasingly during their natural history and oncologists nowadays can use drugs to block some specific driving oncogenes pathways-of therapeutic importance.