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 has over 25 years of experience in the RUO and IVD diagnostics industry, is a co-author on over 95 peer-reviewed publications in the field of oncology and diagnostics, 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 helped develop new and innovative products for 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.

Madeline Repollet has worked in clinical laboratories for >36 years. During that time, she has done bench work as well as management and development of clinical labs. She is Board certified by the American Society for Clinical Pathology as a Cytotechnologist, CT(ASCP) and is licensed by the State of Florida as a Cytologist. Her education includes a BS in Biology, MS in QA/RA and PhD in Healthcare Administration.

Dr. Repollet has many years of experience working in the clinical laboratory quality and regulatory environments. She has obtained CLIA Certifications as well as New York, Rhode Island, California and other states licensing, as required for operational practice for the labs. She is also versed in clinical laboratory international standards like ISO15189, which accreditation she has obtained for 2 different clinical laboratories. 

Dr. Repollet has more than 23 years of experience specifically in liquid biopsy testing, particularly on Circulating Tumor Cells (CTC) and was co-developer of the image analysis criteria for CELLSEARCH® CTC. She is co-author on several peer-reviewed publications on CTCs.

Steven Gross specializes in assay design and product development focusing on the verification, qualification, and transfer of IVD/RUO assays to both manufacturing/ operations and clinical lab services for BioPharma clinical trials. Steven has more than 30 years of experience in the liquid biopsy oncology diagnostic industry developing instrumentation, kits, and assays. Steven is a co-author on more than a dozen peer-reviewed publications and co-inventor on 5 patents in the field of oncology and diagnostics. 

Steven was the Manager for Clinical Assay Development for ANGLE from June 2021 to November 2023, where he was responsible for assay development and transfer of several RUO products and custom biomarker assays for Pharma customers to the fee-for-service clinical lab services. Prior to joining ANGLE, Steven was Head of CELLSEARCH® Assay Development at Menarini Silicon Biosystems from 2017 to 2021 and Scientist at Veridex/Janssen R&D/Janssen Diagnostics (Johnson & Johnson companies) from 2008 to 2017 where he was responsible for commercializing numerous base kits and custom biomarker assays for the capture and detection of rare cells such as circulating multiple myeloma cells (CMMC), circulating tumor cells (CTC), and circulating endothelial cells (CEC) on the CELLSEARCH® platform. In support of these numerous diagnostic product offerings Steven has leveraged his strong interpersonal skills to engage cross-functionally with R&D, Operations, Commercial, and Pharma customers. Steven started his career with Immunicon, as a key R&D contributor to the founding of the CELLSEARCH® technology. 

Steven has a MA in biology from Temple University and a BS in biology from the University of the Sciences in Philadelphia (now part of St. Joseph’s University).