Diane M. Ward, PhD

Senior Director

Diane Ward is an immunologist with over 20 years of experience in the diagnostic industy and has a comprehensive track record in new product development.  With particular expertise in systems development, design control and project management, Diane has been involved in all phases of the product lifecycle, from feasibility through development, regulatory filings and launch.

Diane comes to Myraqa after nearly three years as Associate Director of Process Development at XDx, a molecular diagnostic company that obtained one of the first clearances under IVDMIA.  At XDx, Diane did extensive work establishing the product development lifecycyle infrastructure as well as core competencies for process development and reagent manufacturing / QC.

Prior to XDx, Diane spent 12 years at Becton Dickinson as a project scientist and project manager.  She was involved in the development of complex products such as the FACSCount, a self-contained system incorporating instrument, software, reagents and controls for automatic counting of CD4, CD8 and CD3 T lymphocytes.  Diane has also served in key QA and Systems Integration positions at diagnostic companies such as Affymetrix and Predicant Biosciences.

Diane holds two degrees in Microbiology and Immunology: a BA from UC Berkeley and a Ph.D. from the University of Arizona.

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Recent Blogs

Great New Companion Diagnostics E-Book Released Today A valuable resource in a hot, but under-informed segment of the market
Oragene Clearance Shows DNA Stabilization is Class II Clearance could have a significant impact on DTCG providers
My Screening Test for Screening Tests Offering up a rare bit of regulatory certainty
The Abolish OIVD Act of 2011 A torches-and-pitchforks approach to LDT regulations

Glossary Terms

Design Control
In Vitro Diagnostic Multivariate Index Assay (IVDMIA)
Quality Control (QC)