OUR MISSION

Chronix Biomedical’s mission is to be at the forefront of cell free nucleic acid technology and bioinformatics. Our mission is to market our medically important laboratory developed tests for monitoring cancer treatment efficacy and transplanted organ health. Our mission is to design laboratory developed supplemental tests for patients at high risk for cancer.

TECHNOLOGY

Cancer patient blood contains cancer and non-cancer DNA. All DNA is extracted from serial cancer patient samples, sequenced in powerful NGS machines and the quantity of cell-free tumor DNA (“tcfDNA”) determined by Chronix Biomedical’s proprietary technology. The propriety technology counts the gains and losses from large sections of chromosomes present in the genome of cancer cells and summarizes the results into a copy number instability score (“CNI score”). Changes in CNI levels during therapy usually indicates a remission or progression of the tumor. The Chronix Biomedical tests have a higher accuracy in monitoring systemic cancer therapy than all traditional biomarkers. Blood Liquid Biopsies are simpler, less invasive and safer to obtain then conventional tissue biopsies.

Organ transplant patients’ blood contains the donor and the organ’s DNA. The company’s technology has enabled the development of a cost-effective and robust liquid biopsy assay with digital droplet polymerase chain reaction (“ddPCR”), which allows the earliest detection of organ transplantation rejection reactions. The amount of Graft derived DNA (“GcfDNA”) is measured in the blood. As with the lack of suitable tests to measure therapeutic efficacy in treating a cancer patient, there is also a lack of accurate biomarkers to determine if a transplanted organ is being rejected by a patient being treated with immunosuppressive drugs.

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.

MANAGEMENT

prof-ekkehard-schutz-m-d-ph-d-facb

Prof. Ekkehard Schütz, M.D., Ph.D., FACB

Chief Executive Officer & Chief Medical Officer

howard-b-urnovitz

Howard B. Urnovitz, Ph.D.

Founder, Chief Science/Strategy Officer

John DiPietro

Chief Financial Officer

Scientific Advisory Board

Coming Soon

Medical Advisory Board

Coming Soon