Validation framework

Nanolix is software, not an IVD

Nanolix is analytical software — not an FDA-cleared in vitro diagnostic device (IVD). When a CLIA-licensed laboratory deploys Nanolix to generate clinical results, that use is a laboratory-developed test (LDT) under the laboratory's own CLIA certificate.

Under the LDT framework (21 CFR Part 809 and CLIA regulations), the implementing laboratory is responsible for the analytical and clinical validation of the test, not the software vendor. This is the same framework under which hospital laboratories operate their own PCR assays, sequencing workflows, and other laboratory-developed methods.

What this means practically

Your laboratory director is the responsible party for validation. You design and execute the validation study. We provide tools and documentation to make that process as efficient as possible for sequencing-based LDTs.

Our LDT-compatible architecture means: the software generates reproducible, version-locked analytical results with complete audit trails, making your validation study executable and defensible under CLIA quality standards.

CLIA requirements for sequencing LDTs

Under CLIA, laboratories must validate LDTs before clinical use for high-complexity testing. Key validation parameters for a sequencing-based pathogen identification test include:

• Accuracy — concordance with an established method (culture-based gold standard)
• Precision — reproducibility across runs, operators, and instrument configurations
• Analytical sensitivity / LOD — minimum input copies for reliable identification
• Specificity — cross-reactivity with related organisms or commensal flora
• Reportable range — analytical measurement range for quantitative outputs
• Reference interval — where applicable for quantitative parameters

Our validation documentation package provides protocol templates for each of these parameters, pre-configured for a nanopore sequencing-based pathogen identification workflow.