Opportunity
The timely and accurate screening and diagnosis of diseases, particularly cancers like prostate cancer, are critical for effective treatment and patient survival. Traditional diagnostic methods, such as prostate-specific antigen (PSA) tests and biopsies, often involve invasive procedures, require specialized laboratory equipment, and are time-consuming. These methods are not suitable for point-of-care applications that demand rapid, low-cost, and non-invasive testing. There is a significant unmet need for a diagnostic tool that can provide sensitive, specific, and convenient detection of disease biomarkers, such as polyamines (e.g., urinary spermine), which are indicators of conditions like prostate cancer. The opportunity lies in developing a portable, user-friendly, and economically viable detection system that enables early and frequent monitoring outside clinical settings, potentially improving patient outcomes through earlier intervention.
Technology
This patent presents an innovative electrochemical detection method and apparatus for determining the presence or concentration of polyamines or their derivatives in a sample, particularly biological samples like urine. The core technology integrates a substance-selective structure, often a molecule-selective electrode, with an electronic device, typically a field-effect transistor (FET). The substance-selective structure features a molecularly imprinted polymer (MIP) layer designed with voids that specifically bind to target polyamine molecules, such as urinary spermine. When the sample is applied, the binding of polyamines to the MIP alters the polymer's permittivity and dielectric constant, consequently changing the electrical capacitance of the structure. This change is transduced into an electrical signal by the connected FET. Specifically, the substance-selective structure functions as or connects to the gate electrode of the FET. The binding event modulates the FET's electrical characteristics, such as its threshold voltage or saturation drain current under applied biases. By measuring these changes, the presence and amount of the target polyamine can be quantified with high sensitivity, even at very low concentrations (e.g., parts per billion levels).
Advantages
- Enables highly sensitive and selective detection of specific polyamines like urinary spermine at very low concentrations (ppb level).
- Offers a non-invasive testing method using biological samples such as urine, improving patient comfort and compliance.
- Facilitates point-of-care diagnostics due to potential for portable, low-cost, and hand-held device integration.
- Employs a solid-state, molecularly imprinted polymer sensor that requires no internal filling solution, enhancing robustness and shelf-life.
- Features a modular design allowing the sensor to be easily tuned or multiplexed to detect different biomarkers by using different MIP templates.
- Utilizes low-voltage operation, ensuring chemical stability of the sample by preventing induced electrolysis.
- Benefits from a fabrication process that is relatively simple, scalable, and compatible with low-cost methods like printing and solution processing.
Applications
- Primary application in non-invasive screening and diagnosis of prostate cancer by detecting urinary spermine levels.
- Potential for detecting other diseases characterized by changes in polyamine profiles (e.g., spermidine, putrescine) in various biological fluids.
- Use in general biomedical research for quantifying polyamines and their derivatives in laboratory samples.
- Deployment in home-use health monitoring devices for regular, personal health checks.
- Integration into clinical point-of-care testing equipment for rapid in-office diagnostics.
- Application in environmental monitoring or food safety testing for detecting specific amine-based compounds.
