A disposable assay for the monitoring of heart failure in the home setting

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 DESCRIPTION (provided by applicant): The objective of this proposed SBIR Phase 1 is to complete the clinical validation of a novel blood assay, pScreen-BNP(tm), for the monitoring and management of heart failure (HF) in the home and Point-of-Care (POC) settings. pScreen-BNP(tm) has several unique features. It is fully disposable (single use) and does not requires bench-top or hand held devices, hence it is easy to use and very affordable; it is also a quantitative and sensitive assay, hence it provides an accurate and precise quantification of the level of Brain Natriuretic Peptide (BNP) in HF patients' blood. BNP is a cardiac biomarker elaborated by heart tissue when stressed due to the onset of heart failure. It is widely known for its specificity and sensitivity in the diagnosis of HF. Heart Failure remains a leading cause of death and disability in elderly Americans, and places a significant burden on the healthcare systems with a cost exceeding $40 billion/year. Early diagnosis is a critical necessity to achieve meaningful change in outcome. pScreen-BNP(tm) marks in this respect, a paradigm shift in HF management. It allows, for the first time, HF patients to frequently monitor their level of heart distress outside of the clinical setting e.g. in the comfort of their homes, similar to the more familiar glucose test. Our solution enables patients and their physicians to respond before physical symptoms occur, preventing otherwise frequent life threatening events and costly re-hospitalizations. pScreen-BNP(tm) is based on a patent-protected technology developed at Carnegie Mellon University, which has been extensively verified in our laboratory. In this Phase I proposal, we will optimize key elements of our latest pScreen-BNP(tm) prototype and complete a detailed validation study that includes positive and negative controls and patient samples collected by our clinical partners. A clinical trial and FDA 510(k) submission would then follow in a Phase II effort.