Implementation of PGx testing in a diagnostic laboratory
Physical space design
- Pre-amplification room
- Post-amplification room
Determine minimum equipment requirements
- Thermal cycler
- Gel electrophoresis equipment
- Gel documentation system
- Dedicated pipettes and molecular biology consumables
- Refrigerator and freezer
Write standard operating procedure (SOP)
- Validation procedures
- Testing procedures
- Troubleshooting procedures
Initial setup and validation
- Test calibration
- Determine validation protocol
- Run precision & accuracy with validated controls
Interpretation & Reporting
- Setup interpretation scripts
- Write/format diagnostic reports
Develop sales collateral
- Develop internal sales collateral
- Develop external sales collateral
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