# DDT-BMQ-0000107 Qualification of the Plasmodium falciparum 18S rRNA biomarker for malaria field studies

> **NIH FDA U01** · UNIVERSITY OF WASHINGTON · 2022 · $250,000

## Abstract

ABSTRACT
Biomarker qualification is a process whereby the analytical and clinical performance of a biomarker is tested to
determine its suitability for a particular Context of Use (COU). Clinical trials of malaria drugs, vaccines, and
other therapeutics benefits from high quality diagnostics, but many of the existing diagnostic modalities such as
rapid diagnostic tests and thick blood smear microscopy are relatively insensitive and/or operator-dependent.
In contrast, molecular diagnostic biomarker testing for Plasmodium falciparum has been shown to be
analytically and clinically sensitive and specific in many settings. In this project, biomarker testing will be
performed on archival samples from malaria endemic site clinical trials and the data will be utilized to support
an expanded Context of Use for the Plasmodium falciparum 18S rRNA biomarker for malaria-endemic field
studies.

## Key facts

- **NIH application ID:** 10616035
- **Project number:** 1U01FD007767-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Sean C Murphy
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2022-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10616035

## Citation

> US National Institutes of Health, RePORTER application 10616035, DDT-BMQ-0000107 Qualification of the Plasmodium falciparum 18S rRNA biomarker for malaria field studies (1U01FD007767-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10616035. Licensed CC0.

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