Malaria Molecular Diagnostic Laboratory
Our Mission: The MMDL supports the global mission to combat malaria by using its highly sensitive and quantitative molecular assays to assess the efficacy of malaria vaccines and drugs in clinical trials and to support field studies aimed at malaria epidemiology and eradication/elimination efforts.
In Controlled Human Malaria Infection or 'CHMI' trials, the goal of molecular diagnosis is early and reliable detection and quantification of parasite-derived biomarkers in peripheral blood to inform treatment decisions about volunteer participants and to determine whether the vaccine or drug had a protective effect.
Since 2011, our laboratory developed and refined highly sensitive tests that target the small subunit or '18S' ribosomal RNA (18S rRNA) of Plasmodium parasites. Scientists have known since the 1980s that these rRNAs are highly abundant in Plasmodium parasites. Even though molecular tests were developed, most tests ended up targeting the parasite genomic DNA that encodes the 18S rRNA rather than the 18S rRNA itself. Our laboratory detects the abundant 18S rRNA itself. This provides a sensitivity advantage since there are ~5,000-10,000 copies of the 18S rRNA produced in each and every infected cell. As part of our efforts, we obtained Biomarker Qualification status through the U.S. FDA for this biomarker for a specific context of use in CHMI trials (link to FDA) and we are continuing these efforts with the FDA to expand the context of use to other clinical trial uses. To detect these 18S rRNAs, we perform Reverse Transcription PCR (RT-PCR) -- the assay can detect a single asexual-stage Plasmodium falciparum parasite in a 50 microliter whole blood sample test volume.
The MMDL is located in the Department of Laboratory Medicine & Pathology, University of Washington in Seattle. MMDL accepts whole blood or dried blood spots (DBS) from IRB-approved clinical trials of drug and vaccine candidates and from epidemiological surveillance studies. The test is also available for clinical use in selected cases and is orderable through UW Laboratory Medicine.
MMDL Accreditations and Activities:
Qualified the Plasmodium 18S rRNA Biomarker through the FDA CDER Drug Development Tool Biomarker Qualification Program (link to FDA site)
Testing laboratory for Seattle Malaria Clinical Trials Center studies
CLIA Certificate #50D2175552
CAP # 8610292