A platform engineered for regulatory, payer and clinical review
InterceptIQ™ has been evaluated across analytical performance categories and benchmarked against prospective clinical cohorts. The data below summarise the studies anchoring the platform's scientific credibility, with acceptance criteria pre-specified prior to unblinding to preserve statistical integrity.
Headline performance across every validation pillar
Reference data developed by Kihealth under accredited laboratory standards, with method comparison against orthogonal ddPCR.
0.5 – 5,000 cp/µL
95% probability · Probit
T1D vs. control · n ≈ 1,847
28 days · 4 operators
At calibrated cutoff
At calibrated cutoff
Performance rendered visually
Selected figures from the analytical and clinical validation dossier. Each chart is a simplified rendering of the underlying study data; full source tables and audit logs are available on request.
T1D vs. control · n ≈ 1,847
0.5 – 5,000 cp/µL · 4-log range
28 days · 4 operators
Reference cohorts (n ≈ 1,847)
Pre-defined acceptance criteria — met or exceeded
The InterceptIQ™ assay was evaluated in accordance with CLSI guidance and internal protocols developed for regulatory submission. Acceptance thresholds were pre-specified before unblinding.
Bias < 2% across operating range
Inter-run CV 1.6% – 5.4%
R² = 0.9999 over a 4-log dynamic range
No cross-reactivity in 96-sample panel
98.1% – 102.4% spike recovery
≥ 7 days · plasma stored at 4 °C
4.5 copies / µL · 95% Probit
Established across 3 cohorts (n ≈ 1,847)
Active and pending clinical studies
A snapshot of the studies currently generating evidence for InterceptIQ™ and BetaIntercept™, spanning academic medical centres, national registries and biobank partners.
| Study | Institution | Population | Status |
|---|---|---|---|
| INS cfDNA in new-onset diabetes | Nemours | New-onset diabetes vs. controls | Active |
| β-cell cfDNA early detection (DAISY) | UC Anschutz | Stage 1–3 T1D + controls | Active |
| cfDNA progression biomarker (TEDDY) | TEDDY Biobank | Genetic-risk children | Pending |
| Beta First™ validation | University of Florida | Early/recent-onset T1D | Active |
| Multiomic liquid biopsy (PDAC) | UC Anschutz | New-onset diabetes; PDAC high-risk | Active |
| Human and de-identified biospecimens | Kihealth / BioIVT | Volunteer donors | Active |
| De-identified residual testing samples | Kihealth | Residual test samples | Active |
| INS cfDNA in new-onset diabetes | USF / Tampa General | New-onset diabetes vs. controls | Pending |
Benchmarked against prospective cohorts
BetaIntercept™ T1 has been studied in a paediatric prospective cohort where the assay reported 87% sensitivity and 85% specificity for Stage-3 T1D classification, with an AUC of 0.904. In retrospective analyses, the assay was associated with a median lead-time of up to 625 days versus standard-of-care HbA1c diagnosis.
These figures are reference research findings and are intended to support continued evaluation in larger, multi-site European cohorts. They are not yet authorised claims for routine clinical diagnosis in the European Union.
Ongoing work being investigated in Europe includes prospective enrolment with academic medical centres, biobank-enabled retrospective analyses, and method-comparison studies with orthogonal molecular techniques.