MOLECULAR DIAGNOSTICS • LABORATORY MEDICINE

Japheth Mdenyo

Molecular Diagnostics Scientist | Medical Laboratory Scientist | Infectious Disease | Assay Validation | Clinical Research

Laboratory medicine professional and molecular diagnostics researcher with more than a decade of experience spanning analytical method validation, infectious disease diagnostics, clinical laboratory operations, quality systems, specimen integrity, and laboratory leadership.

University of Washington M.S.Roche cobas 6800 researchISO 15189 experience

Full academic name: Japheth Keneth Alula Mdenyo.

Clinical laboratory experience with a research-driven molecular diagnostics focus.

I work at the intersection of clinical laboratory medicine, molecular diagnostics, infectious disease testing, analytical validation, and quality systems. My background includes multidisciplinary diagnostic testing, laboratory management, staff development, SOPs, audits, competency assessment, specimen processing, point-of-care testing, and pre-analytical quality.

My graduate training at the University of Washington focused on adapting and validating an automated malaria molecular assay for low-volume and dried-blood-spot specimens, with attention to the practical challenges that affect reliable quantitative performance.

Method validation for Plasmodium 18S rRNA RT-PCR on the Roche cobas automated molecular platform

University of Washington • M.S. Thesis • 2025

Research objective

Adapt a high-throughput malaria molecular workflow for lower-volume and alternative specimen formats.

The study evaluated whether the cobas malaria assay could be adapted for off-label research use with 50 µL whole blood and dried blood spots (DBS), while adding a standard-curve approach for absolute quantification.

150 µL sampleWhole blood or DBS
2Modified processingLow-volume / DBS workflow
3cobas 6800Automated extraction + RT-PCR
4QuantificationStandard-curve analysis

Validation framework

Standard curveLinearityLimit of detectionPrecisionAccuracy / biasCarryoverDBS stabilityMatrix matchingExtraction / elution

Field-compatible sampling meets high-throughput molecular automation.

The project highlights both the promise and the analytical challenges of extending automated molecular systems to low-volume and DBS specimens. Matrix-dependent RNA recovery emerged as an important optimization target, particularly for quantitative performance at lower parasite densities.

Laboratory practice, research, quality, and leadership.

2026–Present

Senior Phlebotomist • Optum Care Washington

Patient-facing specimen collection and processing, Epic/Beaker workflows, pre-analytical quality, point-of-care testing, quality control, and staff mentoring.

2024–2025

Graduate Research Assistant • University of Washington

Analytical method validation of a modified Plasmodium 18S rRNA RT-PCR workflow using the Roche cobas automated molecular platform.

2017–2023

Laboratory Manager • Bomu Hospital

Directed multidisciplinary clinical laboratory operations, ISO 15189-aligned quality activities, staff supervision, validation/verification, workflow improvement, procurement, and laboratory continuity.

2009–2017

Medical Laboratory Technologist / Deputy Laboratory Manager

Multidisciplinary diagnostic testing, phlebotomy, microbiology, infectious-disease testing, biosafety, quality control, specimen processing, audits, and staff training.

Japheth Mdenyo in a clinical laboratory beside a laboratory accreditation certificate

Quality systems are part of the diagnostic method—not an afterthought.

My laboratory leadership experience included ISO 15189 quality systems, SOP development and review, internal audits, competency assessment, corrective actions, quality indicators, proficiency testing, equipment management, biosafety, staff training, and accreditation readiness.

ISO 15189QC / QAInternal auditsSOPsCompetencyBiosafety

Core capabilities

Molecular diagnostics

PCR / RT-PCR principles, Plasmodium 18S rRNA testing, DBS workflows, Roche cobas automated molecular platform, analytical method validation.

Analytical validation

Linearity, LoD, precision, accuracy and bias, carryover, specimen stability, standard curves, matrix effects, and CLSI-aligned validation concepts.

Clinical laboratory medicine

Chemistry, hematology, coagulation, urinalysis, microbiology, immunology/serology, transfusion medicine, specimen processing, and POCT.

Quality systems

ISO 15189, QC/QA, internal audits, SOP development, competency assessment, corrective actions, biosafety, infection prevention, and accreditation readiness.

Pre-analytical quality

Patient identification, venipuncture and capillary collection, specimen integrity, centrifugation, aliquoting, storage, packaging, transport, and stability.

Laboratory informatics

Epic/Beaker, LIS/EMR workflows, electronic order verification, documentation accuracy, KenyaEMR, GX-LIMS, SHIS, and Microsoft Office.

University of Washington graduate training in Laboratory Medicine.

Master of Science in Laboratory Medicine, University of Washington, Seattle, 2025. Graduate research focused on molecular diagnostics and analytical method validation.

M.S. Laboratory MedicineUniversity of Washington • 2025
B.Sc. Medical Laboratory SciencesTechnical University of Mombasa • 2014
Diploma, Medical Laboratory SciencesEldoret Polytechnic • 2008
Japheth Mdenyo on the University of Washington campus

Areas where I can contribute.

Molecular diagnosticsAutomated molecular testing and implementation
Assay development & validationAnalytical performance studies and method optimization
Infectious diseaseClinical and public-health laboratory applications
Clinical researchSpecimen workflows, data quality, and translational testing
Laboratory qualityQuality systems, validation, SOPs, and continuous improvement
Scientific collaborationResearch teams, diagnostics organizations, and laboratories

Interested in molecular diagnostics, assay validation, or clinical laboratory collaboration?

I welcome conversations with diagnostic laboratories, biotechnology and life-science organizations, research teams, public-health programs, and clinical collaborators.