LDT Validation

 Getting LDT Validation Right Has Never Been More Important 

The FDA's LDT rule was vacated in March 2025. CLIA and CMS are now the primary regulatory oversight framework for laboratory developed tests — and labs that were waiting for federal clarity are now asking a more urgent question: does our validation actually hold up?

The answer depends on how the work was designed, not just whether studies were completed. Inspectors look at study design, acceptance criteria, statistical rigor, documentation completeness, and regulatory alignment. Gaps in any of these areas can delay inspections, trigger deficiencies, and put test menus at risk.

Three River Oaks helps diagnostics labs design, execute, and document LDT validations that hold up — not just on paper, but under inspection.

 Senior Advisory Support Across the Full Validation Lifecycle

Our LDT Validation Advisory is structured as advisory-only by design. Your team runs the studies. We make sure they are designed correctly, executed to CLIA and CAP standards, and documented in a way that supports inspection readiness and long-term compliance.

We work across both molecular and immunoassay platforms, across single-analyte and panel tests, and across the full range of CLIA testing complexity levels.

No generic templates. No one-size-fits-all checklists. Senior expertise applied to your specific test, your specific lab, and your specific regulatory context.

 Choose the Level of Support That Fits Where You Are 

We collaborate with laboratories to design and enhance quality systems that support compliance and streamline laboratory operations. Our services include the development and implementation of CLIA-compliant quality systems, strategic insights for quality assurance program design and optimization, review and remediation of existing quality infrastructure, and ongoing regulatory assistance to ensure compliance.

For labs in early planning who need a clear, expert-designed roadmap before committing to full validation.

Includes:

• Validation strategy session
• Study design plan covering required performance parameters
• Protocol templates and documentation framework
• CLIA/CAP regulatory requirements summary for 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.

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
• Up to 3 advisory calls

For well-funded teams moving fast who want a senior advisor embedded for the complete validation lifecycle.

Includes everything in Tiers 1 and 2, plus:

• Unlimited advisory calls for 90 days
• SOP review and compliance gap analysis
• Personnel competency framework review
• Regulatory submission readiness review
• Final documentation package sign-off

What Makes Our Advisory Different 

Our team brings 55 years of hands-on experience in molecular and specialty diagnostics — including real-world LDT development across both molecular and immunoassay platforms. We have designed validation studies, interpreted results, written documentation packages, and supported labs through the full CAP inspection process.

When we advise your team, you are not getting templates and a checklist. You are getting a senior partner who has done this work from the inside — and who understands what inspectors actually look for.

Advisory only — by design. Our LDT Validation Advisory is intentionally structured as advisory-only. This keeps engagements efficient and costs manageable, while giving your team access to the senior expertise that makes the difference between a clean validation and a costly redo.