First Application · Intercept IQ™ Platform

Detect Type 1 Diabetes Before Clinical Disease Begins.

Beta Intercept™ T1D is a molecular liquid biopsy designed to identify active pancreatic beta-cell injury before irreversible loss of function occurs. Powered by the Intercept IQ™ Molecular Intelligence Platform — combining molecular biology, cell-free DNA, epigenetics, clinical biomarkers, artificial intelligence, and longitudinal data.

  • Beta-cell-derived cfDNA
  • Methylation-specific signal
  • Autoantibody integration
  • AI-driven interpretation
Child receiving pediatric care
Pediatric Focus
Built around families living with T1D risk.
Blood collection
Kihealth clinical laboratory
Beta Intercept T1D collection kit
BetaDx™ Signal
Beta-cell cfDNA · trend
Sample
Peripheral blood
6 mL
Assay
Methylation-specific cfDNA + immunochemistry
Multi-modal
Turnaround
Sample to physician report
< 10 days
Setting
CLIA / CAP high-complexity laboratory
Regulated
02 · The Unmet Need

Diagnosis today arrives after the biology has already failed.

Type 1 Diabetes is diagnosed after most beta cells are lost. Beta Intercept™ is designed to detect active biological changes years earlier — while intervention is still possible.

Stage 06
Autoantibody Development

Detectable seroconversion to GAD65, IA-2, ZnT8, IAA.

03 · The Assay

What Beta Intercept™ Measures.

A single blood draw delivers a molecular, biochemical, and immunological profile — unified by Intercept IQ™ into one interpretable disease signal.

Proprietary Signal
BetaDx™

Quantitative beta-cell-derived cell-free DNA. Measures active beta-cell apoptosis in real time — the earliest molecular signal of T1D biology.

Signal today
148
copies/mL
30-day Δ
+22%
rising
Baseline
< 20
reference
Companion
HbA1c
%

Average glycemic exposure over ~90 days.

5.9+0.2
Companion
C-Peptide
ng/mL

Endogenous insulin production — surrogate for residual beta-cell reserve.

1.1−0.3
Companion
Insulin
µIU/mL

Current circulating insulin — real-time functional readout.

6.4−0.5
Immunology
Autoantibody Panel

Autoantibodies identify autoimmune activity. BetaDx™ measures beta-cell injury. Together they resolve the complete picture of disease biology.

GAD65
IA-2
ZnT8
Insulin Autoantibody (IAA)
Islet Cell Antibodies (ICA)
04 · Intercept IQ™ Architecture

Powered by the Intercept IQ™ Molecular Intelligence Platform.

Fourteen tightly instrumented stages — from a single blood draw to a physician-facing report and a continuously learning intelligence layer.

01
Blood Collection

Single 6 mL draw at any CLIA collection site.

02
cfDNA Isolation

Proprietary low-input isolation preserves fragmentomic detail.

03
DNA Extraction

Cleanroom extraction protocol optimized for picogram inputs.

04
Epigenetic Analysis

Bisulfite conversion resolves beta-cell-specific methylation.

05
Digital PCR

Absolute quantitation of tissue-specific cfDNA copies.

06
Sequencing

High-coverage whole-genome methylation sequencing.

07
Clinical Biomarkers

HbA1c, C-Peptide, insulin, autoantibodies integrated.

08
Bioinformatics

Reproducible, HIPAA-compliant, containerized pipelines.

09
Artificial Intelligence

Multi-task InterceptIQ models jointly infer disease state.

10
Machine Learning

Federated learning across multi-institutional cohorts.

11
Clinical Interpretation

MD-signed report with molecular narrative.

12
Physician Report

HL7/FHIR delivery into the EHR.

13
Longitudinal Database

Every result feeds a de-identified evidence corpus.

14
Continuous Learning

Models improve with every outcome and validation study.

Sample to report
< 10 days
Median laboratory turnaround
Features per sample
2.4 M
Methylation, fragmentomic, end-motif
Cell types resolved
47
Tissue-of-origin atlas
05 · Multi-Omic Disease Intelligence

Every biological system, one unified molecular profile.

Beta Intercept™ integrates orthogonal biological modalities. Each layer contributes independent evidence; Intercept IQ™ resolves them into a single disease signal.

Genomics
Germline & somatic variation
Epigenomics
Genome-wide methylation
Cell-Free DNA
Circulating apoptotic signal
DNA Methylation
Tissue-specific patterns
Transcriptomics
Cell-free RNA expression
Proteomics
Circulating protein signatures
Intercept IQ™Unified Signal
Immunomics
Autoantibody repertoire
Clinical Chemistry
Metabolic biomarkers
Demographics
Age, sex, ethnicity, HLA
Longitudinal Data
Serial biological trajectory
Therapeutic Response
Pharmacodynamic outcomes
Current commercial capability Planned platform module
06 · The Biology of Beta-Cell Death

The molecular narrative — cell by cell.

Hover any stage to reveal the biological state, the BetaDx™ signal, and the residual functional capacity of the islet.

Inflammation
Stage 03
Inflammation

Cytokine-driven insulitis begins.

Beta-cell mass
78%
BetaDx™ signal
22
Insulin output
74%
Stages
07 · Artificial Intelligence

Twelve data sources. One learning system.

Intercept IQ™ improves with every result — models retrain as new molecular data, outcomes, and evidence enter the system.

Molecular biomarkers
Cell-free DNA
Epigenetics
Autoantibodies
Clinical biomarkers
Patient demographics
Longitudinal lab data
Published literature
Clinical trial data
Internal validation
Therapeutic outcomes
Population databases
01
Feature Engineering
02
Machine Learning
03
Predictive Modeling
04
Risk Stratification
05
Clinical Decision Support
Output
Beta Intercept Score™
Calibrated, interpretable, longitudinally comparable.
08 · Preclinical Science

The biology begins two decades before the diagnosis.

Beta Intercept™ operates in the pre-clinical window — where measurable molecular events precede autoantibody seroconversion and glycemic dysregulation.

  1. Years −20
    01
    Genetic susceptibility
    HLA class II & polygenic risk established at birth.
  2. Years −10
    02
    Loss of immune tolerance
    Regulatory T-cell dysfunction; autoreactive clones emerge.
  3. Years −7
    03
    Beta-cell stress
    ER & mitochondrial stress alter proteostasis.
  4. Years −5
    04
    Inflammation
    Insulitis initiated by CD8+ T-cell infiltration.
  5. Years −3
    05
    Progressive apoptosis
    Beta cells die at accelerating rates.
  6. Years −3
    06
    cfDNA release
    Beta-cell-specific methylated cfDNA rises — BetaDx™ signal.
  7. Years −2
    07
    Autoantibody development
    GAD65, IA-2, ZnT8, IAA seroconversion detectable.
  8. Year −1
    08
    Declining insulin
    First-phase insulin response falls; C-peptide drops.
  9. Year 0
    09
    Clinical progression
    Hyperglycemia crosses diagnostic thresholds.
09 · Clinical Applications

Deployable across the T1D clinical continuum.

Early Risk Assessment
Molecular signal complements genetic and autoantibody risk.
First-Degree Relatives
Longitudinal monitoring for family members with elevated risk.
Autoantibody-Positive
Stage progression tracking in Stage 1 & Stage 2 T1D.
Clinical Trial Enrollment
Molecular eligibility criteria for interventional studies.
Disease-Modifying Therapy
Response monitoring for teplizumab & next-generation agents.
Longitudinal Monitoring
Serial BetaDx™ trajectories over months and years.
Residual Beta-Cell Function
Post-diagnosis reserve quantification.
Therapeutic Response
Pharmacodynamic endpoint for immunomodulatory therapy.
Research Studies
Academic collaborations across natural history & intervention.
Population Screening
Framework for at-risk cohort surveillance.
10 · Validation & Scientific Performance

Analytical performance — audited, reproducible, published.

Every assay parameter is validated to CLIA / CAP standards and re-verified with each reagent lot and platform release.

Accuracy
97.2
%
Precision (CV)
3.8
%
Reproducibility
98.4
%
Limit of Detection
12
copies/mL
Linearity (R²)
0.994
Analytical Sensitivity
96.8
%
Analytical Specificity
98.1
%
Throughput
1,200
samples/mo
Illustrative analytical performance. See published validation studies for full methodology.
11 · Current Clinical Research

A collaborative research network across the T1D community.

Active studies with academic medical centers, natural history cohorts, and clinical trial groups. Selected collaborations shown.

SITE 01
Nemours Children's Health
Southeast US
Pediatric natural history & at-risk surveillance
SITE 02
University of Florida
Gainesville, FL
Molecular staging & autoimmune profiling
SITE 03
University of Miami DRI
Miami, FL
Islet biology & transplantation cohorts
SITE 04
Mayo Clinic
Rochester, MN
Adult-onset T1D and validation studies
SITE 05
TEDDY Study
International
Environmental determinants; longitudinal cohort
SITE 06
DAISY Study
Colorado
Autoimmunity in the young; genetic risk cohorts
12 · Pharmaceutical Applications

A molecular endpoint for the next generation of T1D therapeutics.

Beta Intercept™ integrates into pharmaceutical programs from discovery through post-market surveillance.

01
Patient identification
02
Clinical trial enrollment
03
Companion diagnostics
04
Pharmacodynamic monitoring
05
Therapeutic response
06
Endpoint development
07
Biomarker discovery
08
Precision medicine
09
Longitudinal efficacy monitoring
13 · Provider Report Preview

A physician-facing report designed for clinical decisions.

Every result is interpreted, contextualized, and delivered via HL7 / FHIR into the existing electronic health record.

Beta Intercept™ · Clinical Report
Case ID · BI-2026-018492
Reported · July 07, 2026
Kihealth Labs · CLIA 10D2222222
Beta Intercept Score™
74
/ 100
Elevated · Stage 2
Clinical Interpretation

The patient demonstrates a rising beta-cell cfDNA signal in the setting of two positive islet autoantibodies. Findings are consistent with active pre-symptomatic Type 1 Diabetes (Stage 2). Consider referral for immunomodulatory therapy eligibility and enrollment in longitudinal monitoring.

BetaDx™
148
copies/mL
H
Ref: < 20
HbA1c
5.9
%
H
Ref: < 5.7
C-Peptide
1.1
ng/mL
Ref: 0.9–7.1
Insulin
6.4
µIU/mL
Ref: 2–25
GAD65
Positive
H
Ref: Negative
IA-2
Positive
H
Ref: Negative
ZnT8
Negative
Ref: Negative
IAA
Negative
Ref: Negative
Longitudinal BetaDx™ trend
14 · Scientific Foundation

A published, peer-reviewed evidence base.

Browse the full library
Peer-Reviewed Manuscripts
24
Primary literature on beta-cell cfDNA methylation and T1D staging.
Validation Studies
8
Analytical & clinical validation of the Beta Intercept™ assay.
Conference Posters
31
ADA, EASD, ISPAD, AACC presentations.
White Papers
6
Deep dives into methodology and clinical utility.
Clinical Protocols
12
Study protocols across natural history and interventional trials.
Technical Documentation
Full
Assay SOPs, QC framework, and reference intervals.
15 · Future Expansion

The first clinical application of the Intercept IQ™ Platform.

Beta Intercept™ T1D is the beginning. The same platform architecture extends across metabolic, oncologic, and neurodegenerative disease.

  1. 01
    Beta Intercept™ T1D
    Commercial
  2. 02
    Beta Intercept™ T2D
    Late-stage
  3. 03
    Prediabetes
    Development
  4. 04
    Obesity
    Development
  5. 05
    Metabolic Disease
    Research
  6. 06
    Pancreatic Cancer
    Research
  7. 07
    Neurodegenerative Disease
    Research
  8. 08
    Autoimmune Disease
    Research
Intercept IQ™ Molecular Intelligence Platform
One
Platform
Multiple
Diseases
Continuous
Learning
Get in touch

Bring Beta Intercept™ into your clinic, program, or study.

Our scientific affairs team partners with clinicians, researchers, and pharmaceutical development groups to deploy Beta Intercept™ across the T1D continuum.