CALL FOR TECHNOLOGY TRANSFER – EXPRESSION OF INTEREST (EOI)

Chitra NT-proBNP device for early diagnosis of suspected heart failure (The development of the device was funded by ICMR )

Medical Device Classification : Class C

Technology Readiness Level : TRL 3

Intended end use : A portable point-of-care system that supports optimized treatment of patients with symptoms of heart failure by enabling easy diagnosis and management of heart failure in primary care. It allows for the early diagnosis of the marker NT-ProBNP in patients with suspected heart failure, monitoring patients with compensated left ventricular dysfunction, and risk stratification of patients with acute coronary syndromes.

Product description : NT-proBNP Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of -terminal B-type natriuretic peptide precursor (NT-proBNP) in human serum plasma. This test aids in diagnosing, prognosis, and evaluating Heart Failure (HF).

Novelty : Fluorescent technology incorporated in Lateral flow assay

Current Development stage/ Evaluations done :
# Proof of concept/ Minimal clinical validations completed. The strips are validated on a custom made equipment.

Further work :
1. Performance requirements
2. Comparative study
3. Regulatory requirements
4. Software and validations
5. Risk management
6. Applicable Standards and Requirements
7. Stability requirements
8. Capital equipment requirements

Co-development mode :
# The industry and the Institute shall share responsibilities for further development. After completion of development the industry shall have the first right to refusal for Technology Transfer.