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Dr. Dianne De Santis
Founder & Clinical Scientist
Dr Dianne De Santis is a clinical scientist with more than 30 years of experience in Histocompatibility, Immunogenetics & Molecular Genetics, specialising in advanced HLA technologies, transplant immunology & immunogenetics, diagnostic innovation, training and laboratory accreditation. She is PhD‑trained, a Fellow of the Faculty of Science (RCPA), ASHI Laboratory Director qualified, an adjunct of The University of Western Australia and is completing Good Clinical Practice (GCP) training.
Across her career at PathWest Fiona Stanley Hospital, she led major developments in PCR‑based HLA typing, capture hybridisation, next‑generation sequencing and third‑generation sequencing, including more than a decade specialising in Oxford Nanopore Technology full‑length sequencing. She was the project leader for the first NGS for HLA genotyping component in the 16th IHIWS and led the development of the world’s first accredited rapid ONT‑based HLA typing assay for deceased donor organ allocation.
Her technical expertise includes CDC and flow cytometric crossmatching, HLA antibody testing and DSA assessment, digital PCR for copy number variation, rare variant detection by NGS/TGS, KIR genetics, ABO genotyping and CMV IgG ELISA testing from buccal swabs.
Dianne’s accreditation and governance experience spans NATA, NPAAC, ASHI, EFI and TGA frameworks. She has worked as a NATA technical assessor and TGA Production/Quality Manager, with extensive experience in quality systems, regulatory compliance, data integrity, laboratory software validation and large‑scale informatics and automation projects, including the SOFT SCC Laboratory Information System.
She has significant experience in haematopoietic stem cell transplantation donor selection, family segregation analysis and complex histocompatibility reporting across unrelated, related, haploidentical and cord blood transplantation, as well as solid organ transplantation, including deceased donor allocation, living donor crossmatching, HLA antibody analysis and donor‑specific antibody assessment.
Dianne is committed to mentoring and capability‑building, providing tailored training for scientists, clinicians and ASHI Director‑in‑Training candidates. She has supervised undergraduate, Honours, Master’s and PhD students, and delivered lectures, tutorials and wet‑lab practicums to university cohorts. She has served as International Histocompatibility Summer School faculty at a number of summer schools.
Beyond her scientific work, Dianne is a board director for Racing for MNDi, a WA charity dedicated to accelerating research into inherited forms of motor neurone disease. When she’s not working, she enjoys travelling, good wine and food, cheering her boys on from the footy sidelines, and spending time with family and friends.
✔️ Support for in‑house and commercial IVD assay development, validation and verification to ensure robust, reproducible and accreditation‑ready diagnostics.
✔️ Technical and clinical reporting for Histocompatibility & Immunogenetics reporting within appropriate laboratory frameworks. ✔️ Expert support in interpreting challenging HLA genotypes, immunogenetic profiles, and assisting clinical teams with critical decision‑making in complex case studies. ✔️ Review and optimisation of laboratory workflows to improve efficiency, reduce manual burden and maintain high‑quality output. ✔️ LIS and automation support, including development, testing and optimisation of laboratory information systems and liquid‑handling workflows for consistency, traceability and operational performance.
✔️ Technical and clinical reporting for Histocompatibility & Immunogenetics reporting within appropriate laboratory frameworks. ✔️ Expert support in interpreting challenging HLA genotypes, immunogenetic profiles, and assisting clinical teams with critical decision‑making in complex case studies. ✔️ Review and optimisation of laboratory workflows to improve efficiency, reduce manual burden and maintain high‑quality output. ✔️ LIS and automation support, including development, testing and optimisation of laboratory information systems and liquid‑handling workflows for consistency, traceability and operational performance.
✔️Tailored training online programs and workshops for laboratory scientists and clinicians.
✔️ Training and mentorship for ASHI Director‑in‑Training candidates and fellows, supported by detailed case‑study review and feedback.
✔️ Deliver competency‑based staff training aligned with regulatory requirements, ensuring teams maintain the skills, documentation and proficiency needed for compliant laboratory practice.
✔️Provides specialised technical training across key H&I and molecular assays, including PCR, digital PCR, capture hybridisation, next‑generation sequencing, and third‑generation sequencing with a focus on Oxford Nanopore Technology platforms, as well as flow cytometric crossmatching, HLA antibody testing, ABO genotyping and CMV IgG antibody testing from buccal swabs.
✔️ Training and mentorship for ASHI Director‑in‑Training candidates and fellows, supported by detailed case‑study review and feedback.
✔️ Deliver competency‑based staff training aligned with regulatory requirements, ensuring teams maintain the skills, documentation and proficiency needed for compliant laboratory practice.
✔️Provides specialised technical training across key H&I and molecular assays, including PCR, digital PCR, capture hybridisation, next‑generation sequencing, and third‑generation sequencing with a focus on Oxford Nanopore Technology platforms, as well as flow cytometric crossmatching, HLA antibody testing, ABO genotyping and CMV IgG antibody testing from buccal swabs.
✔️ Research design and project planning
Guidance on study design, methodology selection and experimental planning to ensure clear, feasible and scientifically sound research.
✔️ Data interpretation and scientific input
Support interpreting HLA genotypes, antibody profiles, sequencing outputs and assay‑specific data to generate accurate, clinically meaningful conclusions.
✔️ Manuscript and abstract development
Structured support in drafting and refining manuscripts, abstracts and posters for clarity, accuracy and alignment with journal or conference requirements.
✔️ Scientific writing and editing
High‑quality writing and editorial support across background, methods, results and discussion sections for both clinical and research audiences.
✔️ Quality and reproducibility
Advice on documentation, QC metrics, acceptance criteria and workflow consistency to strengthen reliability and reproducibility in research outputs.
✔️ Grant and ethics application support
Input into grant proposals, ethics submissions and project justification statements to ensure clear scientific rationale and robust methodology.
✔️ Collaboration and project mentorship
Ongoing scientific mentorship, troubleshooting and strategic guidance throughout the lifecycle of research projects.
Education, training & mentorship
laboratory strategy & technology consulting
research, publications & scientific Writing
core services
✔️ Guidance on achieving and maintaining ASHI, NATA, NPAAC and TGA standards.
✔️ Support developing quality management documentation; SOPs, policies, competency records, corrective actions and governance materials to strengthen compliance and accreditation readiness.
✔️ Comprehensive internal audits and pre‑assessment reviews, including realistic desktop or onsite audits, to identify gaps early and prepare laboratories confidently for accreditation visits.
✔️ Assistance with post‑inspection recommendations and implementation.
✔️ Development and evaluation of QC metrics and acceptance criteria to ensure robust assay performance, consistent data quality and compliance with regulatory and accreditation standards.