Kelly Gordon, Ph.D., MB(ASCP)CM
Founder
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.
Dr. Gordon has hands-on experience analytically and clinically validating tests spanning genomic, proteomic and transcriptomic technologies, establishing and managing biobanks, and leading biomarker discovery programs. Dr. Gordon has an expansive network and can guide CRO and diagnostic partnership decisions based on project-specific technical and regulatory needs.
Dr. Gordon knows the regulatory pathways for clinical trial assays and in vitro diagnostics and has direct experience developing tests in accordance with CAP, CLIA, NYS-DOH, EU (IVDD & IVDR), and US-FDA regulations. Dr. Gordon has led regulatory submissions and interactions to support both the investigational use (in clinical trials) and marketing of tests. Dr. Gordon will guide the optimal regulatory strategy for your product to ensure marketing application success.
Scientific Advisory Board Member
MNM Bioscience
iNDX.Ai
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.
Dr. Gordon has hands-on experience analytically and clinically validating tests spanning genomic, proteomic and transcriptomic technologies, establishing and managing biobanks, and leading biomarker discovery programs. Dr. Gordon has an expansive network and can guide CRO and diagnostic partnership decisions based on project-specific technical and regulatory needs.
Dr. Gordon knows the regulatory pathways for clinical trial assays and in vitro diagnostics and has direct experience developing tests in accordance with CAP, CLIA, NYS-DOH, EU (IVDD & IVDR), and US-FDA regulations. Dr. Gordon has led regulatory submissions and interactions to support both the investigational use (in clinical trials) and marketing of tests. Dr. Gordon will guide the optimal regulatory strategy for your product to ensure marketing application success.
Scientific Advisory Board Member
MNM Bioscience
iNDX.Ai
Education and Professional Certifications
Ph.D., Pharmacology
Duke University, Durham, NC
B.S. magna cum laude, Molecular and Cellular Biology
University of Arizona, Tucson, AZ
Postdoctoral Fellowships, Cancer Biology
Translational Genomics Research Institute, Phoenix, AZ
Arizona Cancer Center, Tucson, AZ
Certifications
Technologist in Molecular Biology, American Society of Clinical Pathology
Graduate Certificate in Cell and Molecular Biology, Duke University
Ph.D., Pharmacology
Duke University, Durham, NC
B.S. magna cum laude, Molecular and Cellular Biology
University of Arizona, Tucson, AZ
Postdoctoral Fellowships, Cancer Biology
Translational Genomics Research Institute, Phoenix, AZ
Arizona Cancer Center, Tucson, AZ
Certifications
Technologist in Molecular Biology, American Society of Clinical Pathology
Graduate Certificate in Cell and Molecular Biology, Duke University
