The goal of this SBIR proposal is to develop a novel technology that promises to confer pregnancy test-like stability to immunoassays requiring signal amplification and precise quantification.
Aim 1 focuses on developing multiplex-ready assays for individual analytes from whole blood, and demonstrating performance parity with clinical standards.
Aim 2 translates these assays to a single, self-contained, POC-ready platform. Our preliminary data show representative analyte detection using the proprietary SeLux platform in the physiologic range with excellent comparability with clinical standards, as well as thermal and temporal stabilities of the methodology. Based on these results, we believe the 9-month development plan outlined for Phase I will demonstrate the essential platform features required for device scale-up and full clinical validation in Phase II. The assembled team is uniquely suited to this plan, including expertise in POC testing and nanosensing, and direct experience in assay development, microfluidics design and optical detection. Furthermore, our close clinical partnership embeds the eventual customer in the research and development process. By overcoming the traditional immunoassay robustness barrier and enabling parallel detection of biomarker panels, the SeLux platform will usher in a new era of POC devices critical for value- based care.
The development of a patient-operated, point-of-care (POC) device capable of quantifying fertility hormones from finger stick blood samples will increase patient access to in vitro fertilization (IVF) as well as enhancing the procedure's efficiency. Our approach to developing amplified immunoassays is to utilize proprietary engineered nanoparticles to produce an immunoassay with remarkable stability, allowing storage for long times under ambient conditions, and capable of simultaneous detection of multiple biomarkers from a single, finger-prick blood sample. In addition, the proposed research innovation is relevant to public health because it has the potential to improve the standard of care in other medical fields in which remote, multiplex biomarker monitoring provides a basis for enhancing value-based care.
