Immunoprobe-Based cfDNA Assay to Assess Organ Injury Reading Cell-Free DNA in Body Fluids to Spot Organ Damage

This patent describes a method for measuring cell-free DNA (cfDNA), fragments of genetic material floating in body fluids, as a way to assess whether an organ is being injured. It comes from the University of California, and uses an immunoprobe-based, hybridization approach to quantify cfDNA.

The Problem

When cells in an organ are damaged or die, they release fragments of DNA into the blood and other biofluids. Measuring this cell-free DNA can reveal organ injury, for example the early rejection of a transplanted kidney, often sooner and less invasively than a biopsy. The catch is that cfDNA is present in tiny amounts and mixed with everything else in the fluid, so quantifying it reliably usually demands complex laboratory sequencing. There is a need for a simpler, robust way to measure cfDNA that could be used more routinely to monitor organ health.

What This Invention Does

The patent provides methods and compositions to quantify cfDNA in biofluids using a hybridization approach with immunoprobes. Rather than relying solely on sequencing, the method uses probes that bind to the target DNA so the amount of cell-free DNA can be measured and used to assess organ injury status. By reading cfDNA levels from a biofluid sample, the assay offers a liquid biopsy style window into whether an organ is being damaged, with potential application in monitoring transplant patients and other conditions where early detection of organ injury matters. The application is a divisional of earlier Australian filings, indicating it belongs to an established patent family.

Key Features

• cfDNA quantification. The method measures cell-free DNA present in biofluids.
• Immunoprobe approach. Probes that bind the target DNA underpin the measurement.
• Hybridization-based. Detection relies on probe-to-DNA hybridization rather than sequencing alone.
• Organ injury readout. Measured cfDNA is used to assess the status of organ injury.
• Biofluid sample. The assay works from body fluids, supporting a less invasive test.

Who Is Behind It

The applicant is The Regents of The University of California, the governing body that holds intellectual property for the University of California system. The named inventors are Minnie M. Sarwal, Tara K. Sigdel and Joshua Y. Yang, researchers known for work on transplant biomarkers.

Why It Matters

Non-invasive tests that catch organ injury early can change outcomes, especially in organ transplantation, where detecting rejection before damage accumulates allows earlier treatment. A simpler cfDNA assay that does not require full sequencing could make such monitoring cheaper and more widely available. Protecting the method in Australia supports its potential use in local clinical and diagnostic settings.

Related Concepts

• Cell-free DNA – the biomarker the assay measures.
• Liquid biopsy – the broader approach of testing biofluids instead of tissue.
• Immunoassay – the probe-based detection family this method draws on.
• Organ transplantation – a key application for early organ-injury detection.
• Biomarker – the general concept of a measurable indicator of a biological state.

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AU 2026201931 was published in the Australian Official Journal of Patents on 2 April 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.