Analytical & Clinical Validation
A platform engineered for regulatory, payer, and clinical review.
InterceptIQ™ has been validated across every category of analytical performance and benchmarked against prospective clinical cohorts. The data below summarize the studies that anchor the platform's scientific credibility.
Performance scorecards
Headline performance across every validation pillar.
CLIA / CAP / NYSDOH · Method comparison vs. orthogonal ddPCR
0.5 – 5,000 cp/µL
95% probability · Probit
T1D vs. control · n = 1,847
Across 28 days · 4 operators
At calibrated cutoff
At calibrated cutoff
Validation framework
Eight pre-defined acceptance criteria. All met or exceeded.
The InterceptIQ™ assay was validated in accordance with CLSI guidance and internal protocols developed for regulatory submission. Acceptance criteria were pre-specified before unblinding to preserve statistical integrity.
Accuracy
Bias < 2% across operating range
Precision
Inter-run CV 1.6% – 5.4%
Linearity
R² = 0.9999 · 4-log dynamic range
Specificity
No cross-reactivity in 96-sample panel
Recovery
98.1% – 102.4% spike recovery
Stability
≥ 7 days · plasma at 4 °C
Limit of Detection
4.5 copies / µL · 95% Probit
Reference Range
Established across 3 cohorts (n = 1,847)
Analytical performance
Linearity, precision, and limit of detection — measured at scale.
Analytical linearity
R² = 0.9999 · 0.5 → 5,000 copies / µL
Precision · inter-run CV
CV < 6% across operating range
Limit of detection · Probit
LoD95 = 4.5 copies / µL
Diagnostic performance · ROC
AUC = 0.979 · T1D vs. control
Clinical reference ranges
Established stratification across healthy, at-risk, and active cohorts.
Reference ranges were established prospectively across three IRB-approved cohorts with longitudinal sampling. The calibrated cutoff yields 94.6% sensitivity and 97.8% specificity at the operating point.
Clinical reference ranges
Stratification across cohorts (n = 1,847)
Multi-site methylation architecture
Three independent epigenetic signals.
One calibrated intelligence score.
Rather than relying on a single biomarker, InterceptIQ™ interrogates multiple tissue-specific methylation loci across the insulin gene. The joint signal raises specificity, lowers false-positive rate, and produces a clinically interpretable disease intelligence output.
Open chromatin in pancreatic β-cells; hypermethylated in non-β tissue.
β-cell specific demethylation; conserved across human islet donors.
Independent confirmatory locus; lowers false-positive rate vs. single-site assays.
Calibrated weighted combination — auditable, interpretable, and reproducible across cohorts.
Methods & transparency
Reproducibility is part of the product.
Pre-registered protocols
Acceptance criteria, statistical analysis plans, and stopping rules are pre-registered before sample analysis.
Containerized pipelines
Every analytical run executes inside a versioned, hash-pinned container, enabling third-party re-execution.
Orthogonal confirmation
Methylation calls are cross-validated against ddPCR and an independent whole-genome bisulfite reference.
Open methods
Sequencing chemistry, basecaller version, and reference atlas builds are documented in the Publication Center.