About Molecular Diagnostics Consulting
Molecular Diagnostics Consulting (MDxC) is comprised of a team of expert consultants providing molecular diagnostic product development services to biotechnology companies in the life science industry. MDxC specializes in developing FDA, RUO, and LDT molecular diagnostic assays for cancer detection, infectious disease detection, and pharmacogenetics using amplification (end-point PCR, TMA, quantitative real-time PCR, and digital PCR) and in-situ hybridization (ISH) technologies. Our services meet the needs of new start-ups or established fast-growing laboratories at every stage of product development, from project planning to product launch. Services include molecular diagnostic assay design and development, clinical specimen procurement, sample processing methods, regulatory compliance guidance, project management, and generating documentation for 510k FDA or CLIA submission.
- Project planning
- Project management
- Molecular diagnostic assay design & development planning
- Regulatory compliance guidance
- Clinical study planning
- Clinical specimen sourcing
- New laboratory set-up
Please visit our Services page for more details.
About the Founder
Sylvia A. Norman, PhD, PMP is the Founder of Molecular Diagnostics Consulting.
Dr. Norman has 12 years of experience in developing products for the molecular diagnostic market. She specializes in designing, developing, and validating molecular diagnostic assays. Her skills include generating sequence alignments, sequence database searches and retrieval, primer/probe design and optimization, patent sequence database searches, isolation of DNA/RNA/proteins from clinical samples (blood, fresh and frozen tissue, FFPE, saliva, Pap samples, and skin cells, etc.), PCR cloning and mutagenesis, and generating SOPs and manufacturing transfer documents. Dr. Norman has several years of experience managing and directing R&D projects and leading teams developing products for FDA and CLIA approval. She is an inventor on 10 patents and has authored publications resulting from her work at the San Diego biotech companies Gen-Probe and Nanogen. Dr. Norman is a certified project manager (PMP#1357539, Sept 2010-present) with experience in leading cross-functional teams on FDA and CLIA projects.
About the Team
Our Molecular Diagnostics Consulting team has over 30 years of professional experience in molecular diagnostic product development. Our combined expertise covers all aspects of product development from project planning to product launch. Staffed by experienced industry veterans, you can trust Molecular Diagnostics Consulting with your diagnostic product development out-sourcing needs. Contact us today to discuss your project.