• Boudicca Dx


Assay Development Support

Support Clinical Trials and Commercial Assay Development

Scientific & Medical Writing

Grant Applications, White Papers, Manuscripts & More

Regulatory Support

Diagnostics Regulatory Executive for Emerging Companies

Experience You Can Trust

Boudicca Dx. is a boutique consulting firm specializing in regulatory and technical strategic consulting services to support the development of high-quality, high-value precision medicine testing. Boudicca Dx. has supported over 50 Biopharma (5 acquired by large Biopharma & 3 IPOs), over 25 Diagnostic Companies (licensing of two diagnostic assets to large IVD developers & 4 Breakthrough Designated Devices), and over 10 consulting firms specializing in Quality, Regulatory, & Biostatistics, and Investment Firms (private equity, VCs, & global investment).

About Boudicca Dx

Dr. Gordon is the founder of Boudicca Dx, LLC, a virtual consulting firm for precision medicine testing supporting pharmaceutical and diagnostic companies all over the world. Boudicca Dx. can support all aspects of test development to reduce costs and timelines for clients.

Dr. Gordon has worked in oncology over 20 years and the precision testing industry over 10 years developing innovative tests for early cancer detection, companion and complementary diagnostics, infectious diseases (including COVID-19), inflammatory bowel disease, neurodegenerative diseases, and disease monitoring.

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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