OUR MISSION

Chronix Biomedical, Inc. is a molecular diagnostics company offering laboratory developed blood tests for cancer monitoring, supplemental evaluations and screening patients at high risk for cancer. Our mission is to be at the forefront of cfDNA technology and bioinformatics. We offer revolutionary diagnostics developed by doctors for doctors, to detect cancer early, precisely monitor & actively manage.

TECHNOLOGY

In recent years many new scientific findings concerning cancer research have been reported, which have led not only to new therapies but also to new diagnostic methods. Today we know that in a very large number of cases a tumour is indicated by substantial changes in the genetic material of the degenerated cells. This difference between the genetic material of the tumor cells and the normal cells of the body can be detected with modern procedures.

Many tumors release their cellular content such as DNA into the bloodstream e.g. due to cell death. These tumour-specific changes, at sufficiently high concentration, can be detected and quantified as cell-free tumour DNA in the blood.

Cancer is a disease in which mutations in the genomic DNA of an individual cell lead to a disruption of the normal checks and balances (homeostasis), which in normal state ensure that cell multiplication is matched closely to the body’s needs. A cancer cell has lost the ability to respond to homeostatic needs and continues to divide relentlessly, in one or multiple (metastatic) sites, e.g. driven by positive (oncogene) or lack of negative (suppressorgene) influences.

These mutations in the already developed tissue/organ (somatic) cells lead to cancer (e.g. breast, lung, colon) and in the overwhelming majority of adult cancers this follows after the accumulation of multiple mutations. There is evidence suggesting that aneuploidy, which appears as amplifications and/or losses of large sequences of genetic material, develops earlier than the bulk of mutations, which occur in single DNA base pairs**. This aneuploidy is a major hallmark of genomic changes in malignant cell transformation, which occurs early and is the underpinning foundation of our CNI scoring assays.

The blood analysis to determine cell-free tumour DNA is a new tool, which can help in the assessment of the efficacy of drug therapies in tumour diseases. The CNI-Score we provide is reflecting the amount of circulating tumour DNA.

NEXT GENERATION SEQUENCING

Next Generation Sequencing (NGS) is a method which allows scientists to determine the sequence of the whole human genome, and such DNA “mapping” can now be performed on circulating cell-free DNA (cfDNA) in the blood that is derived from dying (“turning-over”) cells. Indeed such cfDNA is continuously entering the bloodstream, with a turnover half life of some minutes, before the body digests and recycles the constituents. What has been appreciated is that tumor-derived cfDNA circulates in the bloodstream with concentrations varying from below 1% to more then 80% and can be differentiated from normal DNA by the mutational “fingerprint”-best detected by the ‘defining’ gains and losses (DNA Copy Number Instability or CNI score).

After sequencing of the cfDNA the individual fragments are uniquely mapped to the human genome according to their respective sequence. Fragment counts per genomic region are compared to the distribution obtained in normal reference samples. Genomic regions with fragment counts that significantly deviate from this normal distribution represent regions with gains and losses present in the tumor genome. These regions can be compared in the serial sampling and can indicate e.g. the appearance of a new probably more aggressive cancer clone. This information can provide actionable information.

liquid biopsy

NGS of cell-free DNA in Healthy Humans

Beck, J. et al. Profile of the circulating DNA in apparently healthy individuals. Clin Chem. 2009; 55: 730-8.

Circulating nucleic acids (CNAs) have been shown to have diagnostic utility in human diseases. The use of mass sequencing and bioinformatics provides the basis for new diagnostic approaches that use CNAs as biomarkers for both malignant and nonmalignant diseases.

cancer diagnostics world day

Breast Cancer cfDNA with NGS

Beck J, Urnovitz HB, Mitchell WM, Schütz E. Next generation sequencing of serum circulating nucleic acids from patients with invasive ductal breast cancer reveals differences to healthy and nonmalignant controls. Mol Cancer Res 2010; 8:335-42.

Chronix has first used the NGS technology for investigation into the use in breast cancer with very promising results.

cancer diagnostics

Prostate Cancer Blood Test

Schütz, E., et al. Chromosomal Instability in Cell-Free DNA Is a Serum Biomarker for Prostate Cancer. Clinical Chemistry 2015; 61: 239-248.

Tumor-specific cell free DNA (cfDNA) present in serum and plasma provides a real-time, easily accessible surrogate. We demonstrated variations in the number of cfDNA sequences circulating in the serum of patients with prostate cancer compared with healthy controls.

OUR EXPERTS

prof-dr-med-dr-h-c-michael-oellerich

Prof. Dr. med. Dr. h.c. Michael Oellerich

FACB, FAMM, FFPath (RCPI), FRCPath

“The knowledge that we have gained over the past year now suggests to us that we are able to provide to doctors and their patients the ability to diagnose at the most earliest stage the presence of cancer in their body.”
Howard Urnovitz