• Boudicca Dx

    Best-In-Class Precision Medicine Testing Accelerator

LDT & IVD Validation Advisement

Immediate & actionable guidance on developing & validating precision medicine tests (LDTs & IVDs) spanning diverse non-oncology & oncology applications, specimen types & technologies

Rx & Dx Co-development Advisement

Fit-for-purpose clinical biomarker & companion diagnostic co-development strategies based on Biopharma clinical development experience, IVD industry know-how, deep technical acumen & contemporary regulatory insights

Global IVD Regulatory Advisement

Regulatory insights from global Rx & Dx development experiences, global Biopharma clinical trial deployment & submitting global IVD regulatory submissions with global consulting partners

Best-In-Class Consulting Team

Based in Boston, Nashville, San Diego, & San Francisco

Boudicca Dx. is a global precision medicine testing accelerator with a best-in-class team of consultants & strategic alliance partners that is immediately deployed as a unified team to help clients become first-in-class and deliver precision therapies & high-value, high-quality precision medicine testing to patients faster. Boudicca Dx. supports precision medicine testing development (LDTs & IVDs) from concept through commercial launch.

Boudicca Dx. has supported 56 Biopharma (8 acquisitions & 3 IPOs), 36 Dx (LDT & IVD) Developers (2 acquisitions, out-licensing of 3 tests, & 5 breakthrough-designated devices), multiple consulting & investment firms.

Boudicca Dx. has supported clients with both non-oncology (21 clients) & oncology (71 clients) precision medicine programs. Oncology experience includes both hematological malignancies & solid tumors. Non-oncology experience includes Alpha-1 antitrypsin deficiency (AATD)-lung disease, Alcohol Use Disorder, Alzheimer’s Disease, autoimmune disease, arrhythmogenic cardiomyopathy, cardiac Friedreich’s Ataxia, chronic respiratory disorders, DiGeorge syndrome/22q11.2 deletion syndrome, GRN-related frontotemporal lobar degeneration, Hemophilia A, infectious diseases, Inflammatory Bowel Disease, Fabry Disease, Fibrosis, Parkinson’s Disease, Preeclampsia, Septic Shock, Transthyretin (ATTR) Amyloidosis, and X-linked chronic granulomatous disease.

Boudicca Dx. has supported clinical biomarker and companion diagnostic (CDx) co-development for antibody-drug conjugates, allogeneic CAR T cell products, autologous T cell therapies, bispecific T-cell engagers (BiTEs), gene therapies (Adeno-associated virus [AAV] vectors, CRISPR/CAS9 lipid nanoparticles (LNPs), immunotherapies, monoclonal antibodies, small molecule inhibitors, RNA interference-based therapies, and T cell receptor natural killer cell therapies.

Our Services

Founding of Boudicca Dx

Dr. Gordon is the founder of Boudicca Dx. She has direct Biopharma, clinical laboratory & IVD industry experience built on top of technical acumen acquired from developing many molecular and cellular-based assays to explore the phenomenon of cancer cell epithelial to mesenchymal transition during her PhD training in Pharmacology at Duke University.  This is when Dr. Gordon first became captivated with testing blood and tissue specimens to understand the underlying biology of disease; she had the opportunity to follow a pancreatic tumor tissue specimen taken from a patient in the operating room (distal pancreatectomy) to the pathology laboratory to see the journey of this precious specimen from the body to the bench for biomarker testing.

After her post-doctoral training in translational oncology, Dr. Gordon developed molecular Laboratory Developed Tests (LDTs) hands-on as a ASCP-certified molecular technologist in a Molecular Diagnostics CLIA-certified laboratory & has published on the development of a novel proteomic-based early breast cancer detection LDT developed in a CLIA/CAP laboratory.

Dr. Gordon’s passion is precision medicine testing and making sure that every precious specimen that leaves a patient’s body is maximally used to understand the biology of their disease to more effectively manage their disease & identify therapeutic options.

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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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