Kihealth Labs molecular diagnostics laboratory with scientists working at advanced sequencing instruments

The Science Behind Earlier Detection

Discover how the InterceptIQ™ Platform combines advanced molecular diagnostics, β-cell biology, cell-free DNA, and artificial intelligence to generate actionable insight into metabolic disease — before traditional clinical markers become abnormal.

The Clinical Problem

Disease begins long before symptoms.

Type 1 and Type 2 diabetes develop silently for years before HbA1c, fasting glucose, or symptoms appear. By the time a patient is diagnosed, half of β-cell function may already be lost — and complications have begun.

8+
Years of silent β-cell injury before T2D diagnosis
50%
β-cell function already lost at clinical diagnosis
1 in 3
U.S. adults with undiagnosed prediabetes
~$413B
Annual U.S. cost of diabetes & complications

Why Earlier Detection Matters

A continuum where every stage is an opportunity to intervene.

InterceptIQ™ is positioned at the earliest biological stages — where intervention is most effective and disease progression is still reversible.

Earliest biologyConventional detection
Stage 3

Molecular Signals

cfDNA, epigenetic, and methylation signatures appear.

Beta Cell Biology

Where metabolic disease begins.

Pancreatic β-cells produce the insulin that keeps blood glucose in balance. In both T1D and T2D, β-cells are silently injured, stressed, and lost long before clinical disease appears.

  • Direct evidence of active β-cell injury — not a downstream proxy
  • Detects stress before insulin output fails
  • Anchored in three decades of peer-reviewed islet biology research
Pancreatic islet of Langerhans cross-section showing beta cells
Cell-free DNA fragments in plasma — molecular illustration

Cell-Free DNA Technology

A molecular fingerprint of tissue injury.

When β-cells are injured, short DNA fragments with tissue-specific methylation patterns are released into the bloodstream. We measure these fragments directly from plasma — a non-invasive readout of β-cell health in real time.

Fragment size
~160–200 bp
Source
Apoptotic & stressed cells
Sample
Standard plasma tube
Specificity
Methylation-based

Digital Droplet PCR

Quantifying biology, droplet by droplet.

ddPCR partitions each sample into tens of thousands of nanoliter droplets, enabling absolute quantification of rare molecular signals with unmatched precision and reproducibility.

  1. 1
    Plasma input
    Cell-free DNA extracted from a standard plasma tube.
  2. 2
    Droplet partition
    Sample partitioned into ~20,000 nanoliter droplets.
  3. 3
    Targeted amplification
    Methylation-specific probes amplify β-cell-derived DNA.
  4. 4
    Absolute quantification
    Droplet-level counting yields high-sensitivity signal.
Digital droplet PCR instrument processing molecular samples

Multi-Biomarker Integration

One panel. Complete metabolic picture.

A single blood draw captures autoimmunity, β-cell injury, insulin reserve, and glycemic control — six signals integrated into one clinical assessment.

β-cell cfDNA
Tissue-specific signal of active injury
Autoantibodies
GADA, IA-2A, ZnT8A, IAA, ICA
C-peptide
Endogenous insulin reserve
Insulin
Functional secretion capacity
HbA1c
90-day glycemic context
Glucose
Real-time metabolic state

Artificial Intelligence

Signals become a unified clinical story.

Our models integrate β-cell cfDNA, autoimmune risk, insulin reserve, and glycemic context into a single, weighted Intercept Score™ — calibrated for clinical decision-making and longitudinal monitoring.

Risk stratification
Trajectory modeling
Treatment monitoring
Intercept Score™
Demo
72
/ 100 · Elevated risk
β-cell cfDNA78
Autoimmune panel64
C-peptide reserve55
Glycemic context81
Recommend longitudinal monitoring · 90-day reassessment

The InterceptIQ™ Platform

From sample to clinical action.

Five integrated layers translate a routine blood draw into precise, longitudinal insight — engineered for clinical and research workflows.

Layer 1
Sample
Two standard plasma tubes from a routine venous draw.
Layer 2
Assay
Multiplex ddPCR + multi-biomarker panel processed in our CLIA lab.
Layer 3
Signals
β-cell cfDNA, autoantibodies, C-peptide, insulin, HbA1c.
Layer 4
Intelligence
AI integrates signals into a unified Intercept Score™.
Layer 5
Action
Stratified, longitudinal insight for clinical decisions.
Beta Cell Biology
Understanding active β-cell injury before loss of glycemic control.
Cell-Free DNA
Measuring tissue-specific molecular signals through advanced plasma analysis.
Digital Droplet PCR
Highly sensitive molecular quantification engineered for precision biomarker analysis.
Artificial Intelligence
Integrating multiple biological signals into a unified molecular assessment.

Clinical Validation

Grounded in decades of peer-reviewed science.

Our methods are built on more than 30 years of pancreatic islet research and validated through partnerships with leading academic centers, registries, and consortia.

30+
Years of foundational research
17
Peer-reviewed publications
12+
Academic partnerships
CLIA / COLA
Certified laboratory

Key Scientific Takeaways

What makes InterceptIQ™ different.

Earlier Molecular Insight
Detect biological change years before HbA1c or fasting glucose reveal disease.
Beta Cell–Focused Biology
Direct, tissue-specific evidence of active β-cell injury and decline.
Comprehensive Integration
Autoimmunity, β-cell signal, and metabolic markers in one assessment.
Prevention-Oriented
Built for clinicians who intervene before irreversible loss of function.

Partner with Kihealth on the next generation of preventative diagnostics.

For clinicians, researchers, and pharmaceutical partners ready to detect disease at its earliest biological stage.