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

Project Summary NIH SBIR Phase IIJanApplication TitleA disposable assay for the monitoring of heart failure at the point of careAccel DiagnosticsLLC Contact PIAlberto GandiniPh DMBA The objective of this proposed SBIR Phase II is to complete the development and optimization of the pScreen BNPplatform for the monitoring of Heart FailureHFin home patientsThe proposed activities include integration of a smart phone appscale up manufacturing capability that adhere to the FDA Quality Control guidelinesreduce production costand complete a clinical validation study in collaboration with The University of California San FranciscoThe pScreen BNP has several unique featuresIt is fully disposablesingle useand does not requires bench top or hand held deviceshence it is easy to use and very affordableit is also a quantitative and sensitive assayhence it provides an accurate and precise quantification of the level of Brain Natriuretic PeptideBNPin HF patientsbloodBNP is a cardiac biomarker elaborated by heart tissue when stressed due to the onset of heart failureIt is widely known for its specificity and sensitivity in the diagnosis of HFHeart Failure remains a leading cause of death and disability in elderly Americansand places a significant burden on the healthcare systems with a cost exceeding $billion yearEarly diagnosis is a critical necessity to achieve meaningful change in outcomepScreen BNPmarks in this respecta paradigm shift in HF managementIt allowsfor the first timeHF patients to frequently monitor their level of heart distress outside of the clinical settinge gin the comfort of their homessimilar to the more familiar glucose testOur solution would enables patients and their physicians to respond before physical symptoms occurpreventing otherwise frequent life threatening events and costly rehospitalizationspScreen BNPis based on a patent protected technology initially developed at Carnegie Mellon Universityand licensed exclusively Worldwide to Accel Diagnostics