About ClarifyDX Consulting

M. Craig Miller, the founder of ClarifyDX Consulting, specializes in clinical study design and protocol development, clinical trial and data management, biostatistics, regulatory submissions, and manuscript writing and editing (Craig is a co-author on over 95 peer-reviewed publications in the field of oncology and diagnostics). Craig has over 25 years of experience in the RUO and IVD diagnostics industry and has been intimately involved in multiple FDA De Novo and 510(k) device clearances (most recently the De Novo clearances of ANGLE’s Parsortix® PC1 Device and Fujirebio Diagnostics Lumipulse G β-Amyloid Ratio (1-42/1-40)).

Craig was the Clinical Studies Director for ANGLE from March 2016 to December 2023, where he was responsible for driving the clinical development activities of ANGLE.  Prior to joining ANGLE, Craig was the Vice President of Clinical Development at Saladax Biomedical from May 2013 to June 2015, where he was responsible for the design, implementation, and execution of clinical studies for the validation of novel therapeutic drug monitoring assays (MyCare®) in the field of oncology.  Before that, he was the Associate Director of Clinical Research for the Veridex Oncology Biomarkers team at Janssen R&D, a Johnson & Johnson company, where he was responsible for the design, implementation, coordination, and execution of clinical research and development trials for the evaluation, characterization, and commercialization of circulating tumor cell (CTC) assays and technologies.  During his 12-year tenure with Veridex/Janssen R&D (formerly Immunicon Corporation), Craig helped to obtain de-novo FDA clearance of the CELLSEARCH® system and associated components (i.e. CELLTRACKS® AUTOPREP® and CELLTRACKS® ANALYZER® instruments, CELLSAVE preservative tube, and CELLSEARCH® CTC Kits).  Craig also served as the Director of Clinical Affairs and Biostatistics at Fujirebio Diagnostics, Inc. in 2005/2006, where he played a key role in the clinical validation and FDA clearance of the MESOMARK® and ROMA® assays.  Craig started his career in diagnostics at UroCor (now Dianon Pathology, a division of LabCorp), where he held positions of increasing responsibility in Research & Development for new and innovative products in the detection, prognosis, and monitoring of urologic diseases (primarily prostate and bladder cancer). 

Craig has a BS in Biochemistry from Texas A&M University and served in the United States Marine Corps Reserves.