# Commercial Translation of Biomarker-based Platform for Personalized Forecasting of Rapid Lung Function Decline

> **NIH NIH R61** · CINCINNATI CHILDRENS HOSP MED CTR · 2021 · $397,500

## Abstract

ABSTRACT
 An algorithm that predicts lung function decline in patients with chronic lung disease is highly
desirable. We have developed a blood biomarker-based platform that predicts lung function decline in CF
patients with the potential to inform therapeutic interventions to prevent/slow decline, shorten the length
(reducing cost) of clinical trials, and accelerate the examination of potential therapies allowing faster
delivery to the patients. Furthermore, the behavior of molecular biomarkers can inform therapy and
increase success of alleviating disease progression. We have developed a blood biomarker-informed
algorithm that predicts functions decline and propose here to deliver it to the CF care community by achieving
the 3 milestone; 1) (R61 Phase, Year 1): Complete the design and testing of proteomics-informed
GUI that integrates routinely collected clinical/demographic data with marker data to generate real-time
risk prediction of lung function decline and field test GUI utility using the CF learning network, 2) (R33 Phase,
Year 2): Complete a validation of a clinical test of our markers in a large cohort of banked longitudinal
samples at CCHMC and externally at Battelle Memorial Institute, and 3) (R33 Phase, Year 3): Complete
the selection of the optimal algorithm parameters that provide the best specificity and sensitivity for
our markers individually and/or in combination. Development, validation, and dissemination of our
proteomics-informed risk prediction platform will set the stage for a pre-submission meeting with the FDA
for commercial translation of the technology and its delivery to the CF care and patient community.

## Key facts

- **NIH application ID:** 10240328
- **Project number:** 5R61HL154105-02
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Rhonda Szczesniak
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $397,500
- **Award type:** 5
- **Project period:** 2020-09-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10240328

## Citation

> US National Institutes of Health, RePORTER application 10240328, Commercial Translation of Biomarker-based Platform for Personalized Forecasting of Rapid Lung Function Decline (5R61HL154105-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10240328. Licensed CC0.

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