Companion Diagnostics (CDx) laboratories may also do the following tests:

Analytical Validation: Assesses the test's accuracy Testing
precision Testing
and reproducibility in detecting the biomarker or genetic mutation Testing
Clinical Validation: Demonstrates the diagnostic's ability to accurately and reliably predict the therapeutic response in a clinical setting Testing
Sensitivity and Specificity Evaluation: Measures the test's ability to correctly identify patients with and without the biomarker of interest Testing
Companion Diagnostic Co-Development: Involves the simultaneous development of a therapeutic and its corresponding diagnostic test Testing
ensuring compatibility and effectiveness Testing
Regulatory Compliance Testing: Ensures the diagnostic meets all regulatory requirements for safety Testing