When a new diagnostic lab, Catalyst Diagnostic, launched operations in Michigan, they faced a daunting mountain of tasks-assembling workflows, validating assays, ensuring regulatory readiness, and creating thorough documentation. With little internal infrastructure in place, the team turned to Thermo Fisher’s Analytical Validation (AV) services, led by Field Application Scientist (FAS) Dan LaFlamme, for support.
Here are the three biggest advantages they gained from that collaboration-and why every lab could benefit from AV expertise.
1. Accelerated Time-to-Readiness with Cost Savings
One of the biggest hurdles for startup or transitioning labs is the sheer time it takes to validate assays, collect controls, analyze data, and prepare compliant reports.
With AV services, Catalyst reduced this timeline by up to 75% and cut overall validation costs by 50%. Instead of drafting protocols from scratch and struggling through trial-and-error, they leveraged pre-vetted templates, structured validation plans, and targeted expert guidance. This acceleration not only saves weeks, but also enables labs to begin operations sooner, generate data or revenue faster, and avoid costly delays-all while significantly reducing expenses.
2. Built-In Regulatory Confidence
In regulated environments (e.g. CAP, CLIA, ISO), the quality and clarity of validation documentation can make or break accreditations. AV services can help safeguard against surprises. That’s because the AV team ensures that all elements (controls, specificity panels, analytical performance, documentation layout) align with requirements.
3. Expert Partnership & Risk Mitigation
Validation isn’t just a technical exercise-it’s also an exercise in judgment, troubleshooting, and anticipating pitfalls. For Catalyst, working with AV brought access to deep domain expertise: strategic control selection, consultation during unexpected failures, and support when expanding into novel assay formats (like open-array or multiplex). These kinds of interventions prevent missteps, reduce risk, and build capacity within the lab team. With our experienced FAS team, it’s mentorship and backup, not just service.
Why These Benefits Matter for Labs Like Yours
– For new labs or expansions: Time and regulatory pressure dominate. AV helps you move forward with momentum, not stumbling blocks.
– For labs upgrading or changing platforms/assays: Having an independent validation lens reduces blind spots and ensures robustness.
– For labs with limited internal validation experience: AV becomes a force multiplier-supplying both the technical brainpower and confidence in documentation and execution.
Final Thought
By investing in AV services, labs don’t just get validation-they gain speed, expert collaboration, and assistance in compliance assurance. Catalyst Diagnostic’s experience shows that when those three pillars are in place, the foundation is strong, risk is lower, and scientific mission can proceed with clarity and confidence.
If your lab is about to validate an assay, implement a new technology, or prepare for accreditation, analytical validation consulting services may be the strategic advantage you need.
Read the full customer case study
Access more information at thermofisher.com/av