• Boudicca Dx

    STREAMLINING THE DEVELOPMENT OF
    HIGH-QUALITY, HIGH-VALUE PRECISION MEDICINE TESTING

Hands-on Technical Solutions

Deploy immediate assay development guidance based on 20 years of developing & validating assays spanning diverse applications, sample types & technologies in both clinical laboratories & IVD companies

Pragmatic Rx & Dx Co-development

Fit-for-purpose solutions utilizing 13 years of companion diagnostics development experience & regulatory intelligence acquired from working in & with Biopharma, clinical laboratories & IVD companies

Global Regulatory Advisement

Global regulatory insights & intelligence based on 12 years of regulatory experience supporting global Biopharma clinical trials, global health authority interactions & global IVD marketing submissions

Unequaled Know-how

Boudicca Dx. is a boutique consulting firm providing unique, cutting-edge global solutions to support the development of high-quality, high-value precision medicine testing to get therapies & tests to patients faster.

Boudicca Dx. has supported 51 Biopharma (8 acquired by large Biopharma & 3 IPOs), 26 Dx Developers (1 acquisition, licensing of 3 tests to large IVD developers & 4 Breakthrough-designated Devices), as well as multiple consulting & investment firms.

To be a comprehensive precision medicine testing accelerator, Boudicca Dx. recently formed strategic alliance partnerships with superior IVD-trained experts-biostatistics, pathology, quality, regulatory, & technical (validation); this best-in-class team can be deployed immediately to help you become first-in-class!

Founding of Boudicca Dx

Dr. Gordon is the founder of Boudicca Dx, a global precision medicine testing consulting firm.

Dr. Gordon has extensive clinical laboratory & IVD industry experience built on top of technical acumen acquired from building many molecular and cellular-based assays to explore the phenomenon of cancer cell epithelial to mesenchymal transition during her PhD training at Duke University.

After her post-doctoral training, Dr. Gordon developed clinical tests hands-on as a ASCP-certified molecular technologist in a Molecular Diagnostics CLIA laboratory and has published on the development of a proteomic early breast cancer detection test developed in a small CLIA laboratory. Dr. Gordon’s passion is precision medicine testing and she has supported tests spanning diverse applications:

  • early cancer detection
  • companion and complementary diagnostics for oncology, neurodegenerative diseases (Alzheimer’s, Parkinson’s), inflammatory bowel disease, septic shock, pre-eclampsia, and many rare diseases
  • infectious disease ID (respiratory viral panels, COVID-19)
  • AI-informed predictive & prognostic signatures (genomic, transcriptomic & proteomic)
  • digital pathology
  • monitoring tests (heme/solid tumor, tumor-informed/tumor naive MRD testing)

What others say about us…

​Dr. Kelly Gordon and I have worked together on several diagnostic development projects over the past 5 years, and her scientific, regulatory and strategic experience provided the guidance necessary for the success of the biostatistical support that I provided. She is smart, forward-thinking and understands the landscape. Her ability to communicate with her clients and her team members is outstanding. She is dedicated, attentive to details and is vested in the work she undertakes. I look forward to many future collaborations with Kelly.

I have known Dr. Gordon for about 5 years. We worked together at Ventana where it became clear that Dr. Gordon’s knowledge and expertise in assay development were very strong. Dr. Gordon not only has a strong regulatory and scientific background, but she has the ability to develop assays for a variety of purposes including regulatory approval, CE marking, pharmacodynamics/target engagement, etc. As a consultant, Dr. Gordon is instrumental in helping us with assay development and regulatory strategy for our current program in development. On a personal level, Dr. Gordon is straight-forward and easy to work with – I highly recommend her!

Dr. Gordon and I collaborated together on an IVD development project. Her knowledge of the product development process is strong and multilayered. Dr. Gordon had the exceptional ability to take complicated processes and information and translate it to basic laymen’s terms for my staff to understand. The accuracy and clarity of her analytical and clinical validation reports were thorough and impressive, not to mention on time and underbudget. She is accessible, responsive and very efficient. Furthermore, Dr. Gordon has a robust understanding and comprehension of the LDTs in the clinical laboratory. Dr. Gordon has the unique ability to function in both a research/development and clinical laboratory space. I hope to work with her again soon.

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