This technology is a modular, luminescent biosensor that rapidly detects DNA, RNA, small molecules, and proteins at the point of care, using a visible color change measurable by a smartphone, enabling fast, sensitive, and equipment-free diagnostics.
Molecular diagnostics is a rapidly evolving field that plays a critical role in the detection and management of infectious diseases, cancer, and various other medical conditions. The ability to rapidly and accurately identify specific nucleic acids, proteins, or small molecules in patient samples is essential for timely diagnosis, treatment decisions, and disease monitoring. However, there is a growing need for diagnostic tools that can be deployed at the point-of-care—outside of centralized laboratories—to enable immediate results in clinical, field, or resource-limited settings. Such tools must be sensitive, rapid, easy to use, and cost-effective to truly democratize access to advanced healthcare diagnostics. Current diagnostic approaches, such as polymerase chain reaction (PCR), mass spectrometry, and enzyme-linked immunosorbent assays (ELISA), present significant limitations for point-of-care use. These methods typically require expensive, specialized equipment, complex sample preparation, and highly trained personnel, which restricts their use to well-equipped laboratory environments. The need for thermal cycling in PCR, for instance, adds to the complexity and power requirements, while immunoassays often involve multiple washing and incubation steps. These constraints hinder rapid bedside or field diagnostics, delay clinical decision-making, and limit accessibility in low-resource settings. Furthermore, adapting existing platforms to detect new targets often involves substantial reengineering, making it challenging to respond quickly to emerging diagnostic needs.
The technology is a modular luminescent biosensor platform, nLucAFF2, designed for rapid, sensitive, and point-of-care detection of nucleotide sequences, small molecules, and proteins. Built on an engineered nanoluciferase protein, the system produces a visible color shift from green to blue upon binding to a specific DNA sequence, a change that can be observed with the naked eye and quantified using a standard smartphone camera. This eliminates the need for expensive laboratory equipment or specialized personnel, making it highly accessible for bedside or field diagnostics. The biosensor achieves picomolar sensitivity and delivers results within 1–2 minutes, detecting analytes at concentrations as low as 0.1 nM. Its modular architecture allows it to be easily reconfigured for diverse targets: DNA hairpins or aptamers enable nucleic acid detection via a one-pot, isothermal RPA reaction, while the DNA-binding domain can be swapped for aptamers or affibodies to detect small molecules and proteins, respectively. What differentiates this technology is its combination of high sensitivity, speed, and adaptability within a user-friendly, low-cost format. Key innovations include protein engineering enhancementswhich collectively boost brightness, accelerate response, and improve detection limits compared to previous biosensors. The platform’s modularity means that new assays for different analytes can be rapidly developed with minimal changes to the core protein, streamlining the workflow for a wide range of diagnostic applications. Its smartphone-compatible readout further democratizes molecular diagnostics, enabling quantitative analysis in resource-limited settings and making it a transformative solution for infectious disease detection, cancer monitoring, therapeutic drug monitoring, and beyond.
• Rapid detection with a 1-2 minute response time, enabling timely diagnosis at the point-of-care.
• High sensitivity with picomolar detection limits, allowing identification of low-concentration analytes.
• Visible color change from green to blue detectable by the naked eye and quantifiable via a standard smartphone camera, eliminating the need for specialized equipment.
• Modular design adaptable for detecting nucleic acids, small molecules, and proteins by swapping DNA-binding domains with aptamers or affibodies.
• One-pot, isothermal recombinase polymerase amplification (RPA) simplifies the assay workflow for field and bedside use.
• Improved brightness and sensitivity through protein engineering, enhancing detection performance over previous biosensors.
• Low-cost, user-friendly kit format suitable for diverse applications including infectious disease diagnostics, cancer biomarker monitoring, and therapeutic drug detection.
• Enables quantitative, smartphone-based readout, facilitating accessible and portable molecular diagnostics in resource-limited settings.
• Point-of-care infectious disease diagnostics
• Cancer biomarker monitoring
• Therapeutic drug level monitoring
• Serotonin quantification for thrombocytopenia
• Detection of circulating tumor DNA
Patent application 63/850,804 filed on 7/25/2025
• TRL 3
• The proof-of-concept nLucAFF2 biosensor has been fully developed.
• Currently testing in clinical samples.
This technology is available for licensing.