• Boudicca Dx

    Best-In-Class Precision Medicine Testing Accelerator

Precision Medicine Assay Development

Immediate & actionable guidance on developing & validating clinical tests spanning diverse applications based on direct experience developing assays for clinical biomarker testing, clinical laboratories (LDTs) & IVD manufacturers (kits & single-site IVDs).

Clinical Biomarker & Companion Diagnostic Development

Pragmatic clinical biomarker & CDx co-development guidance based on direct Biopharma CDx experience, IVD industry CDx know-how, deep technical CDx assay development acumen & contemporary CDx regulatory insights across diverse biomarkers, specimen types, technologies & indications.

Global Precision Medicine Regulatory Strategy

Deep regulatory insights & intelligence from global Rx & Dx development experience, regulatory submissions for global clinical trials & global IVD regulatory marketing submissions.

Best-In-Class Consulting Team

Boston | Mobile | Nashville | San Diego | San Francisco

Global precision medicine testing accelerator with a best-in-class united team of affiliate consultants & strategic alliance partners that is immediately deployed to help clients deliver first-in-class precision therapies & high-value, high-quality, regulatory compliant precision medicine testing to patients faster.  Clients include biopharma, biotech, clinical laboratories, consulting firms, digital health developers, digital pathology developers, investment firms, IVD & life science research companies.

Our Services

Founding of Boudicca Dx

Kelly Gordon, PhD, MB(ASCP)cm, RAC-Devices founded the consulting firm in 2015 with the mission to help clients streamline their precision medicine product development to get life-changing products to the market faster. Science is the foundation of precision medicine and coupling it with efficient quality and regulatory approaches with a focused commercial strategy enables high-quality, high-value, life-changing precision medicines to get to patients faster.

This is the framework for Boudicca Dx: a united team of affiliate consultants & strategic alliance partners, who are qualified & trained subject matter experts in their fields & can provide immediate expert guidance to seamlessly guide precision medicine development.

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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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