LDT Validation

Getting LDT validation right has never been more important. 

With the FDA's LDT rule vacated in March 2025, CLIA compliance support and CMS have become the primary regulatory oversight frameworks for laboratory developed tests. Labs that were awaiting federal guidance are now facing a more pressing question: does our validation actually hold up? 

The quality of the answer hinges on how the validation work was designed, rather than merely the completion of studies. Inspectors assess various factors including study design, acceptance criteria, statistical rigor, completeness of documentation, and regulatory alignment. Gaps in any of these areas can lead to delayed inspections, trigger deficiencies, and jeopardize test menus. 

Three River Oaks specializes in providing LDT validation services to help diagnostics labs design, execute, and document validations that not only look good on paper but also succeed during inspections.

Senior Advisory Support Across the Full Validation Lifecycle

Our LDT validation services are structured as advisory-only by design. Your team runs the studies while we ensure they are designed correctly, executed to CLIA and CAP standards, and documented to provide the necessary CLIA compliance support for inspection readiness and long-term adherence.

We cater to both molecular and immunoassay platforms, handling single-analyte and panel tests across the complete spectrum of CLIA testing complexity levels.

No generic templates. No one-size-fits-all checklists. Our senior expertise is tailored specifically to your test, your lab, and your regulatory context.

For labs in early planning that require a clear, expert-designed roadmap before committing to full LDT validation services. This package includes: 

- A validation strategy session 

- A study design plan covering essential performance parameters 

- Protocol templates and documentation framework 

- A summary of CLIA compliance support and CAP regulatory requirements specific to your test type 

- One advisory review meeting

For labs actively running or preparing to run a validation study and needing expert guidance at every stage, we offer comprehensive CLIA compliance support. This includes everything in Tier 1, plus: protocol review and detailed written feedback, study design oversight during execution, results interpretation guidance, validation documentation review, final validation report review and sign-off, and up to 3 advisory calls for our laboratory developed tests (LDT) validation services.

For well-funded teams moving fast who want a senior advisor embedded for the complete validation lifecycle, especially in relation to LDT validation services. This package includes everything in Tiers 1 and 2, plus: Unlimited advisory calls for 90 days, comprehensive SOP review and compliance gap analysis for CLIA compliance support, a personnel competency framework review, regulatory submission readiness review, and final documentation package sign-off.

What Makes Our Advisory Different

Our team boasts 55 years of experience in molecular and specialty diagnostics — not just offering CLIA compliance support from the sidelines, but actively designing validation studies, interpreting results, and collaborating closely with CAP inspectors. We understand what they seek because we've been on the front lines when they evaluate.

We focus solely on advisory services by design. Your team handles the execution. We ensure that the work adheres to the highest standards, especially when it comes to laboratory developed tests (LDTs).

Schedule a free 20-minute call. We'll guide you on which tier fits your situation and what your LDT validation services truly require — tailored specifically to your test type, never a one-size-fits-all template.