NIH SBIR Phase-II, Jan 5, 2017 Application Title: ?A disposable assay for the monitoring of heart failure at the point-of-care? Accel Diagnostics, LLC Contact PI: Alberto Gandini, Ph.D., MBA The objective of this proposed SBIR Phase II is to complete the development and optimization of the pScreen-BNP? platform for the monitoring of Heart Failure, HF, in home patients. The proposed activities include integration of a smart phone app, scale up manufacturing capability that adhere to the FDA Quality Control guidelines, reduce production cost, and complete a clinical validation study in collaboration with The University of California San Francisco. The pScreen-BNP 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? 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 would enables patients and their physicians to respond before physical symptoms occur, preventing otherwise frequent life threatening events and costly re- hospitalizations. pScreen-BNP? is based on a patent-protected technology initially developed at Carnegie Mellon University, and licensed exclusively Worldwide to Accel Diagnostics.

Public Health Relevance

NIH SBIR Phase-II, Jan 5, 2017 Application Title: ?A disposable assay for the monitoring of heart failure at the point-of-care? Accel Diagnostics, LLC Contact PI: Alberto Gandini, Ph.D., MBA Accel Diagnostics is a medical technology company developing pScreen-BNP?, the first disposable (single use) blood test for the monitoring and management of heart failure. pScreenBNP? requires a finger-prick blood sample, is intuitive to use, very affordable, and is specifically designed for point-of- care settings, including physicians' offices and patients' homes. The objective of this proposed SBIR Phase II is to complete the development and validation of the pScreen-BNP? in the home setting, following the success completion of the project SBIR Phase I.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44HL127880-03
Application #
9540037
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Lee, Albert
Project Start
2015-04-01
Project End
2019-04-30
Budget Start
2018-08-01
Budget End
2019-04-30
Support Year
3
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Accel Diagnostics, LLC
Department
Type
DUNS #
828862701
City
Houston
State
TX
Country
United States
Zip Code
77057