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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL127880-02A1
Agency Tracking Number: R44HL127880
Amount: $943,624.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-07
Award End Date (Contract End Date): 2020-04-30
Small Business Information
5750 BAUM BLVD # 310
Pittsburgh, PA 15206-3793
United States
DUNS: 828862701
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (832) 641-1900
Business Contact
Phone: (832) 641-1900
Research Institution

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

* Information listed above is at the time of submission. *

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