Malaria Molecular Diagnostic Laboratory

The Malaria Molecular Diagnostic Laboratory (MMDL) at the University of Washington develops and applies cutting-edge tools to improve malaria diagnosis for clinical trials, public health, and patient care. Traditional tests rely on looking for parasites under the microscope or detecting parasite DNA. In contrast, the MMDL measures a highly abundant parasite RNA (18S rRNA), which is present in thousands of copies per infected cell. This makes our test far more sensitive and able to detect even a few parasites in a blood sample.

This sensitivity supports early treatment decisions, public health strategies, and studies of new malaria vaccines and drugs. Since 2011, we have refined our assays and demonstrated that RT-PCR detection of 18S rRNA can reliably detect a single parasite in 50 µL of blood. The FDA has granted biomarker qualification for 18S rRNA in Controlled Human Malaria Infection (CHMI) trials, and we continue working with the FDA to expand its recognized use in clinical studies.

The MMDL is fully certified and located within the Department of Laboratory Medicine & Pathology at UW. We accept whole blood and dried blood spot samples from IRB-approved trials of malaria vaccines, drugs, and epidemiological studies. For patient care, whole blood (EDTA) samples may be submitted with an order from a medical provider through UW Laboratory Medicine & Pathology Client Support Services (800-713-5198 | commserv@uw.edu | Specimen Collection Guide).

Mission: The MMDL supports the global effort to combat malaria by using highly sensitive molecular assays to evaluate vaccine and drug efficacy, strengthen malaria surveillance, and accelerate progress toward eradication.

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 & other partnering clinical sites

  • Reference Laboratory for the World Health Organization External Quality Assurance Scheme for Malaria Nucleic Acid Amplification Testing

  • CLIA Certificate #50D2175552

  • CAP # 8610292