Novel Platform for Improving Access to and Efficacy of Fertility Treatments

DESCRIPTION provided by applicant 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 focuses on developing multiplex ready assays for individual analytes from whole blood and demonstrating performance parity with clinical standards Aim 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 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 PUBLIC HEALTH RELEVANCE 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 procedureandapos 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