Molecular Diagnostics Consulting (MDxC) provides molecular diagnostic product development services at every stage of product development, from project planning to product launch.  We specialize in helping biotechnology companies develop molecular assays regulated by the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Act (CLIA).  Please review our service listing below and contact us to discuss the specific needs of your project.

Project Planning & Project Management

  • Product technology assessment
    • Related intellectual property analysis
    • Competitor analysis
  • Generate/edit quality systems documents
  • Project status tracking
  • Lessons learned assessment

Molecular Diagnostic Assay Design & Development Planning   

  • PCR assay primer and probe design
    • Singleplex or multiplex assays
    • End-point PCR, quantitative real-time PCR or digital PCR assays
  • Primer/probe optimization plan
  • Analytical performance validation plan
  • Clinical performance validation plan

Regulatory Compliance Guidance

  • FDA, cGMP, CLIA regulatory guidance

Clinical Study Planning

  • Clinical Study Design
  • Clinical Protocol Development
  • IRB Documents and Guidance

Clinical Specimen Sourcing

  • Identify sources for clinical specimens required for product development and pre-clinical trial studies

New Laboratory Set-Up

  • Sourcing of laboratory equipment and equipment demos   
  • Laboratory workflow assessment
  • cGMP guidance

Our sister company, Sandhill Crane Diagnostics, now offers digital health products and services. Please click here to view these exciting new offerings and learn more about Sandhill Crane Diagnostics.

Contact us to discuss the specific needs of your project.

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