Dxplora PCR development and manufacturing coordination

PCR Assay Development Support for CLIA Laboratories

Configurable PCR assay formats, evaluation lots, and a coordinated path to repeat manufacturing for laboratories developing or modifying molecular testing workflows.

Dxplora coordinates

  • Assay and format scoping
  • Development partner coordination
  • Evaluation and pilot quantity planning
  • Repeat manufacturing planning

The laboratory owns

  • Intended use
  • Performance specifications and study design
  • Laboratory implementation and quality procedures
  • Patient-result reporting and regulatory pathway