• Boudicca® DX

    Precision Medicine Consulting.
    FDA depth. IVDR precision. AI-powered. Globally deployed.

Test & Device Development

From LDTs to IVDs to SaMD — we have guided development and commercialization of 200+ precision medicine tests, medical devices, and software with regulatory precision.

Clinical Biomarkers & Companion Diagnostics Navigator

15+ years of CDx co-development and fit-for-purpose biomarker validation across all major biomarker types, specimens, and therapeutic areas powering our CDx Navigator knowledge from preclinical through global approvals.

AI-Assisted Global Regulatory & Quality

EU and US regulatory intelligence from 1000+ submissions & decades of hands-on experience. AI-assisted navigation of IVD and device regulations without the guesswork — and preserve your cash runway doing it.

Boudicca® DX is an on-demand team of precision medicine experts deployed instantly to move your product from concept to global approval — faster, leaner, and smarter than going it alone.

⬛ 50+ years combined precision medicine expertise — the intelligence behind every engagement

⬛ AI Regulatory intelligence powered by Claude (Anthropic) — public data only · expert review at every step

⬛ 20+ years Reimbursement & Market Access

⬛ 150+ clients advised — biopharma, IVD, labs & investors · 10 years

⬛ 200+ global trials supported — EU, US & rest of world

⬛ 1,000+ regulatory submissions — EU, UK, US, APAC & S. America

⬛ $10M+ saved across client engagements — preserving cash runways

⬛ 100% repeat engagement rate · 100% client satisfaction

Let’s talk. 30 minutes, no obligation → courtney@boudiccadx.com

Explore our Services
EU IVDR & MDR Experts
White Papers and Case Studies

Biomarkers are not indication-specific — they are a scientific layer that cuts across therapeutic areas. The proof: Boudicca® DX brings platform-level biomarker expertise across 15 therapeutic areas, from oncology to women’s health — expertise that travels with you across your portfolio, not just your lead program.

Built for this Moment

Dr. Kelly Gordon founded Boudicca® DX on a simple, urgent belief: no life-changing therapy, device or test should stall because of a knowledge gap that an expert could fill in a day.

As a regulatory strategist, translational scientist, and biotech investor, Dr. Gordon built a team of immediately deployable experts who operate with scientific rigor, real-world pragmatism, and a deep respect for your budget. When you partner with Boudicca® DX, you’re not hiring a consulting firm — you’re adding a force multiplier to your team.

Meet the Team

What clients say about Boudicca® DX…

“Finding the right treatment for the right patient is what we also strive to do but biomarker-driven patient selection in early development can often be more hype than reality. That is, unless you have a thought partner like Kelly Gordon from Boudicca Dx. Kelly is steeped in hands-on experience and real-world practicality. She is both a thinker and a doer when it comes to diagnostic strategy development and driving interactions with health authorities on diagnostic approaches for a patient enrichment. I cannot say enough positive things about Kelly as a solution focused leader in the diagnostics space and would highly recommend her to anyone.”

“Kelly and her team at Boudicca Dx are the rare force multiplier that allows emerging companies to compete with the larger established players in the complex field of diagnostics. Kelly is expertly at home with the complexity of the underlying science, the various phases of test development and the clinical validation strategy required to enter the market. Kelly brings all this to bear in her regulatory action plans, communicates very effectively, and brings a rare passion to her work. We look forward to much continued success with Kelly and Boudicca!”

“Alentis is leveraging Boudicca Dx’s broad expertise in companion diagnostics to help guide the development of a new diagnostic test to detect and quantify CLDN1 in human tumor tissues. During this collaboration, they have shown to be an experienced partner that knows the regulatory environment very well and provides excellent advice. The support for our IND submission was very helpful.”

“I’ve had the privilege of working with Kelly on multiple biomarker projects across multiple companies, all seeking various levels of regulatory approval. I always recommend seeking Kelly out due to her thoroughness, knowledge, and quality of work. Through her and her network of experts at Boudicca Dx, we outlined strategies for data generation and analysis that have led to approvals as well as projects where it was helpful to realize we needed to focus our intended use and dataset to more favorably compete in a complicated space. In all cases, the result was a stronger clinical, regulatory and commercial strategy in diagnostic biomarkers. Given the rapid pace, the fluctuating attitudes of the regulatory agencies, the costs involved and the analyses necessary, it’s invaluable to have a partner as reliable and competent as Kelly and Boudicca Dx.”

“I have had the privilege to work with Kelly for about 5 years.  If I had to choose one word that describes her it would be AWESOME!  Kelly is bright, innovative, solution oriented and just a great person to work with overall.  I refer and work with Kelly on a number of clients in the drug/diagnostics space and she is my number one person to pull in when my clients are seeking the best advice on companion diagnostic development and working with CDRH.  Kelly not only can advise the client, work with FDA on their behalf but also work with diagnostic companies to bridge discussions between the Company and the Diagnostic partner.  Kelly develops diagnostic strategy and delivers successful outcomes.  She is highly respected by FDA and can influence them thru communications including  briefing packages, INDs, NDA/BLAs and meetings.  Kelly is a Strategic Partner to Advyzom and I can totally trust and high respect for her to deliver for our clients.”

“It has been a pleasure working with Kelly for our regulatory needs. Kelly’s professionalism, insight, and rapid responsiveness were just what we needed. Integral Molecular’s Membrane Proteome Array (MPA) is the first technology accepted for the FDA’s pilot ISTAND program. Being the first to submit to a new regulatory space comes with a lot of uncertainty. Kelly’s knowledge and guidance was a major contributor to the strength of our Qualification Plan submission and provided us with confidence as we moved through the program. Our team will continue to use BoudiccaDx for this and other regulatory consulting needs.”

“Kelly was engaged by Context Therapeutics to develop a custom IVD for patient enrichment to support a first in human clinical trial. Kelly is an absolute star who is a pleasure to work with and someone Context looks forward to working with for many years to come. Highly, highly recommend!”

“Kelly is an extraordinarily adept regulatory consultant who is worth her weight in gold. She helped us plan from the most nascent stages of regulatory readiness aspirations through execution. She brings an exceptional degree of clarity and simplicity to what otherwise can feel like an overwhelmingly complex process and “just gets it done”. Not only did she make everyone on our team feel comfortable with a strategic plan and the concrete steps involved in carrying this out, as an advisor who would regularly join calls and in-person meetings with large pharma customers, her ability to ask the right questions and be able to respond confidently to those of customers, markedly helped bring multiple of key deals/contracts across the line.”

“I’ve had the privilege of collaborating with Kelly on numerous projects, preparing the biomarker plan for the clinical programs. Her extensive expertise in the biomarker and diagnostic landscape is unparalleled. Kelly’s ability to foster valuable introductions, orchestrate apple-to-apple comparisons, getting the right match of the technique to the question and facilitate collaborations is instrumental in advancing products to patients. Her focus on the most effective development path that provides the right tools for the question at hand is unparalleled.

Beyond her technical skills, Kelly is a pleasure to work with. Her exceptional responsiveness and ability to navigate the complexities with ease make her an invaluable partner. I wholeheartedly recommend Kelly to anyone seeking to accelerate their biomarker and diagnostic strategies.”

“I consider Kelly a key thought partner and part of a team of experts I rely on in my consulting practice as I span multiple engagements across many companies. Unsolicited feedback about Kelly and what she provides for many early stage companies is unanimous and consistent. “Incredibly valuable advice” “Practical and fit-for-purpose companion diagnostic development plans” “is there anyone in the field that Kelly does not know?” Kelly has also been a partner and colleague with me at many US FDA interactions and her writing and oration style are bar none. She is and will always be my “go to” for any precision medicine approach for any company I work with.”

“I had the great pleasure working with Kelly on our lead program at Artizan Biosciences. We had developed a laboratory assay but needed to take it to the next level to ready it for clinical trials. Kelly recommended several excellent CROs to help us through the process, and then supported us as we interviewed them and gathered quotes. We ended up with a great partner and a robust assay. In addition, Kelly guided us through our assay validation strategy development and helped us create a blueprint and budget for late stage development and commercialization, even though we were a few years away from that. She was a great member of our team and a delight to work with, and we all learned from her expertise. I would recommend her to any team looking to develop a strong diagnostic strategy!”

“I have had the privilege of working with Kelly in two companies where I served as CMO and several companies where I am an advisor. Kelly’s unparalleled expertise in the biomarker and diagnostic landscape is genuinely second to none. Her generosity matches her deep knowledge in providing valuable introductions and facilitating collaborations that are critical in advancing products to patients. Kelly’s focus on cost-efficiency and resource management ensures that her clients are always guided towards the most effective diagnostic development paths.  Moreover, Kelly is an absolute pleasure to work with—she is incredibly responsive, often jumping on meetings at a moment’s notice, which is a godsend in the fast-paced world of biotech product development. Her ability to navigate the complexities of diagnostics with ease and professionalism makes her an indispensable partner. I highly recommend Kelly to anyone seeking to accelerate their diagnostic and regulatory strategies.”

“Kelly and Boudicca Dx provided us with crucial input on our patient selection approach for a rare genetic target in oncology.  Not only was her guidance key to our clinical diagnostic development strategy, but also she proactively managed a number of our vendors to help identify patients in real-time for the clinical trial.  Kelly goes deep into the science, while at the same time bringing a mastery of how to navigate the increasingly complex diagnostic development & regulatory landscape and knowledge of the most up-to-date changes in the requirements.  She integrated fully as a member of the team and was a pleasure to work with!  We would definitely consider Kelly and the Boudicca Dx team for our future translational and diagnostic development needs.”

“I recommend (without reservation) Kelly Gordon and the Boudicca Dx., LLC team! I’ve worked with Kelly for more than 3 years on everything from biomarker discovery, CDx planning and lab developed tests. Most recently we have worked on using MRD in liquid tumors to improve outcomes in our patients. This is a complex area with no real standardization across multiple platforms and Kelly’s advice has been extremely valuable.”

“Kelly is the best. If a companion diagnostic may be part of the development or a company needs to select vendors for biomarkers and pharmacodynamics, Kelly is the person.”

“Kelly knows her stuff! She has deep knowledge in IVD development. I have learned a lot from her from partner selection, contract set up, FDA interactions to validation. Regardless of technical, regulatory and logistics, she knows it all. In addition, she is highly efficient and fun to work with. I highly recommend her to whoever needs consultation for companion diagnostic development.”

“Kelly is a global leader in diagnostic technical and regulatory research and development. I have employed Kelly’s consulting expertise across multiple companies, targets and types of assays including NGS and IHC. Kelly is able to get up to speed quickly, has strong relationships with diagnostic companies and has built a high degree of credibility with the FDA and other global regulatory agencies. She is always aware and incorporating the latest technical and regulatory guidance to make sure her advice is optimized for current and future practice.”

“Kelly is a fantastic resource who is very knowledgeable and experienced in companion diagnostic development and related oncology test development. She helped us file an FDA breakthrough device application on Biocept’s CNSide in early 2021 that was ultimately denied by the agency, but helped establish our route to a more robust assay validation and clinical development plan. This included an expanded analytical validation for quantitative analysis of CSF tumor cells including additional tumor types and a multi-institutional prospective clinical study to establish the clinical performance and utility of the assay compared to standard of care work-up for suspected leptomeningeal metastasis in patients with advanced solid tumors. She was also a terrific educational resource spending several days with our team in San Diego in 2022 to advance our understanding of pharmaceutical clinical trial requirements and related topics, particularly as related to CLIA laboratory developed tests for niche markets such as CSF testing for CNS metastasis.”

Kelly helped us navigate FDA communication in a swift and effective way. Highly recommend.

Boudicca Dx has been advising Hawkeye on the regulatory strategy for Hawkeye’s biosensor technology. The Hawkeye biosensors are a novel technology that can detect the activity of enzymes involved in chronic inflammatory diseases such as cancer and autoimmunity; all compatible with non-invasive samples such as blood, saliva and exhaled breath. Hawkeye has focused initially on developing a blood test for the early detection of lung cancer. Boudicca Dx has provided instrumental, confident and assured regulatory guidance, refining the intended use and providing prompt and clear feedback as questions arose. Indeed Boudicca Dx deep scientific background has been very helpful in also providing analytical validation guidance based on their experience with other cancer detection assays. The team has too many strengths.

I am pleased to recommend Dr. Kelly Gordon. Her insights contributed significantly to a critical IVD matter during our preparations for a pre-IND interaction. Dr. Gordon’s extensive experience, professionalism, expertise were instrumental as we assessed the role of an IVD in our early clinical planning.

I have known Kelly for a long time. I worked with her when she was at Kura Oncology and have kept in touch with her. I have been impressed with her breadth of knowledge in the diagnostic field. She is a diagnostic expert with experience and knowledge not only about diagnostic/companion diagnostic development but also about diagnostic instruments and methodologies…be it IHC or RT-PCR or NGS or FISH etc. for nucleic acid protein detection. She has kept abreast of the latest development in the field and I am always looking forward to her posts on LinkedIn.

I would add that her greatest strength is in providing guidance on regulatory strategy and submissions to FDA. I wish her the best and hope she continues to share her knowledge and help the diagnostic community.

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.

It’s a real privilege to write this recommendation for Kelly Gordon. Kelly has the extremely rare qualities of not only being exceptionally bright, knowledgeable, experienced and creative in her thinking and problem solving, but is a true pleasure to work with. I had the good fortune to work with Kelly on an in vitro diagnostic (IVD) commercialization plan for a new oncology biomarker.

The project required providing a regulatory strategic plan for bringing the biomarker to market as an IVD in the U.S. Kelly did a masterful job in presenting all the various regulatory pathway options available for submitting through the FDA, and anticipating what the agency would likely challenge or require, as well as ways to potentially expedite the process. She was instrumental in outlining the various clinical studies that would be needed to pursue each regulatory path and the timelines and risks associated with each option. Kelly was extremely good at problem solving, especially in today’s increasing complex and ever changing regulatory climate.

On a personal level, Kelly is an incredibly warm, thoughtful team player with a great sense of humor and a true joy to work with. She is a welcome and vital part of any team.

Boudicca Dx (Kelly Gordon) and I had the pleasure of working together at Gossamer Bio since 2018. Kelly is not only a person of integrity, she is an outstanding scientist and consultant. During our time working together, I could always depend on Kelly to show up on time, prepared, with a wealth of knowledge and experience. She is energetic, happy, fair, dependable, and mostly importantly, possesses a wonderful sense of humor.

I recall a time we were trying to sort out a particular assay to be run to screen patients for a Phase 2 clinical study. Kelly thought about the problem outside of the box, and offered up a number of different options that we could pursue, depending on how much risk we wanted to take, how much money we wanted to spend, and how fast we wanted to do. That is exactly the sort of work product my company and I need, as we try to fearlessly transform the practice of medicine together. Kelly then went the extra mile, beyond the strategy, to help implement the plan, and put all the pieces together.

​I would hire Kelly as a full-time employee in a minute, but it’s clear that she enjoys being a consultant, and is clearly very good at doing so. Boudicca Dx (Kelly Gordon) would contribute to, and thrive in, your organization, and I’m sure you’ll be happy working with her.

Kelly has worked with my team for the last several years on a diagnostic development project. Kelly has been a huge asset to the team with her scientific and regulatory strategic acumen. She is always well prepared, focused, and delivers high quality work products. Team members really enjoy interacting with her and are quick to say “let’s get Kelly’s input”; a sign that Kelly is a great consultant and a valued member of the team. Diagnostic development can be challenging but Kelly makes it seem easy!

Ready to accelerate your program? Book a complimentary 30-minute call

courtney@boudiccadx.com

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