LDT Test Development Services

---

We can help your lab design and execute a robust analytical validation study according to  CLIA/CAP requirements:

• Precision
• Linearity
• Accuracy
• Reproducibility
• Robustness
• Reportable/Reference range

Optimize your study design with our help to incorporate:

• Intended Use
• Reference Standard (Comparator)
• Sample Selection
• Study type (Prospective, Retrospective, Cohort, Case control, etc
• Sample Size
• Performance Metrics

Key to reimbursement, Clinical Utility studies need to demonstrate that using your testing solution will impact and guide clinical decisions that actually improve patient outcomes or change clinical management in a beneficial way through:

• Randomized Controlled Trial (RCT)
• Prospective Decision Impact Study
• Retrospective Outcome Correlation
• CRO engagement