CLC excels in setting up new diagnostic laboratories, as well as supporting existing laboratories. Our consultants have expertise with many instruments, and applications, such as Pharmacogenetics, Nutrigenomics, molecular oncology, molecular infectious disease, and other clinical applications. We have experience with the following methodologies:

  • QuantStudio 12K Flex and other QuantStudio models
  • QuantaBio Q real-time PCR
  • Luminex and other bead-based technologies
  • Microarray
  • RFLP
  • MALDI-TOF genotyping
  • Droplet Digital PCR
  • Sanger Sequencing
  • Next Generation Sequencing

CLC can help you obtain your goal of building out a high quality, compliant, and successful Molecular Diagnostic laboratory. New laboratory setups include (but are not limited to) the following:
  • Applying for licensure and accreditation
  • Completion of regulatory forms such as CLIA and COLA applications
  • Identification of laboratory space and lab design
  • Establishment of the test menu
  • Setting up laboratory vendor accounts and procuring supplies
  • Choosing and validating a Laboratory Information System (LIS)
  • Generation of all necessary policies, procedures, forms, charts, and laboratory signage
  • Workflow assistance
  • Project management
  • Creation of a requisition form and final report template
  • Assisting with validation of test methodology
  • Enrollment in proficiency testing program
  • Establish Quality Control / Quality Assessment programs
  • Perform a mock on-site survey with our inspection team, including summary report

The following are some ways we can help with process improvement in your Molecular Diagnostics laboratory:

  • Assistance with method validation/method optimization
  • Development of documentation such as Standard Operating Procedures and policies for CLIA, COLA, CAP, and other accreditation agencies
  • Choosing/validating a Laboratory Information System (LIS)
  • Workflow optimization assistance
  • Creation of a requisition form and final report template
  • Establishment of a Quality Control/Quality Assurance program
  • Perform a mock inspection tailored to your laboratory’s licensure and accreditation

Call today to speak to a pre-assessment consultant to see if CLC is a good fit for your organization.