DDT-BMQ-0000100 Qualification of the Plasmodium falciparum 18S rRNA biomarker for malaria-endemic controlled human malaria infection studies

Objectives

In this project, biomarker testing will be performed on archival samples from controlled human malaria infection studies at malaria-endemic sites and the data will be utilized to support an expanded Context of Use for the Plasmodium falciparum 18S rRNA biomarker for these type of challenge studies in malaria-endemic regions.

Principal Institution

University of Washington (UW), United States

Principal Investigators / Focal Persons

Sean C. Murphy

Rationale and 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.

External reference

NIH Project details

Thematic Categories

Diagnostics

Date

Sep 2023 — Jun 2024

Total Project Funding

$249,222

Funding Details

Food and Drug Administration (FDA), United States

Grant ID: U01FD008123

Project Site