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

DESCRIPTION provided by applicant The objective of this proposed SBIR Phase 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 patientsandapos 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 $ 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 k submission would then follow in a Phase II effort PUBLIC HEALTH RELEVANCE Diagnostics is a medical technology company currently developing pScreen BNP tm the first disposable single use blood test for the monitoring and management of heart failure pScreen BNP tm requires only a finger prick blood sample is intuitive to use very affordable and is specifically designed for point of care settings includig physiciansandapos offices and patientsandapos homes