Kihealth Labs
Kihealth Labs molecular diagnostics laboratory

One Disease Interception Platform.
Multiple Clinical Applications.

Intercept IQ™ is a scalable molecular diagnostics platform that powers disease interception across clinical care, research, pharmaceutical development, and population health through a single integrated technology platform.

Explore the portfolioSee applications
1
Unified Platform
4+
Disease Programs
cfDNA
Single Blood Sample

A Single Platform Supporting Multiple Clinical and Research Applications

From pediatric prevention to pharmaceutical development, Intercept IQ™ generates molecular intelligence across the full continuum of care and discovery.

01

Early Detection & Risk Identification for Pediatric Type 1 Diabetes

Identify ongoing beta cell injury before clinical diagnosis, enabling earlier intervention and longitudinal monitoring in at-risk pediatric populations.

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02

Metabolic Health Screening for Adults with Type 2 Diabetes

Detect progressive beta cell dysfunction and support earlier identification of metabolic disease before irreversible pancreatic damage occurs.

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03

Clinical Decision Support

Provide clinicians with actionable molecular intelligence that complements traditional biomarkers to improve diagnosis, monitoring, and treatment decisions.

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04

Population Screening Programs

Support large-scale screening initiatives designed to identify individuals at elevated metabolic risk before symptomatic disease develops.

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05

Clinical Trial Stratification

Improve patient selection, risk stratification, and endpoint evaluation for metabolic disease clinical trials.

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06

Pharmaceutical Development

Support companion diagnostics, therapeutic development, and biomarker-driven clinical research for pharmaceutical partners.

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07

GLP-1 Therapy Monitoring

Monitor biological response to GLP-1 therapies using longitudinal beta cell health measurements to complement traditional metabolic assessments.

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08

Disease Progression Monitoring

Track changes in beta cell biology over time to evaluate disease progression and therapeutic effectiveness through serial testing.

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09

Academic Research & Scientific Discovery

Provide investigators with advanced molecular tools for translational research, biomarker discovery, and precision medicine studies.

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Explore each application in depth.

Pediatrician examining a young child with parent in a bright clinical exam room
Application 01

Early Detection & Risk Identification for Pediatric Type 1 Diabetes

Beta Intercept™ T1D detects beta-cell derived cfDNA released during ongoing pancreatic injury — a molecular signal that can appear years before autoantibody seroconversion or dysglycemia. For pediatric patients with family history or elevated genetic risk, this creates a window for closer monitoring, earlier education, and intervention before overt disease.

Clinical Workflow
At-Risk Pediatric Patient
Blood Draw
Methylation Analysis
Beta Cell Injury Score
Clinical Follow-Up
Real-World Use Cases
  • First-degree relatives of T1D patients
  • Screening after autoantibody positivity
  • Longitudinal monitoring of at-risk children
  • Post-diagnosis residual beta cell tracking
Key Benefits
  • Detection before autoantibody positivity
  • Earlier intervention opportunities
  • Reduced risk of DKA at diagnosis
  • Enables emerging disease-modifying therapies
Target Users
Pediatric endocrinologistsPrimary care pediatriciansT1D research consortia
Adult metabolic health consultation
Application 02

Metabolic Health Screening for Adults with Type 2 Diabetes

By the time HbA1c is elevated, up to 50% of beta cell function may already be lost. Beta Intercept™ T2D reveals beta cell stress and injury upstream of traditional glycemic markers — allowing clinicians to identify high-risk adults during the prediabetic window when lifestyle, pharmacologic, and metabolic interventions are most effective.

Clinical Workflow
At-Risk Adult
Metabolic Panel
Intercept IQ™ Testing
Beta Cell Health Score
Preventive Intervention
Real-World Use Cases
  • Prediabetes risk stratification
  • Adults with obesity or metabolic syndrome
  • Family history of T2D
  • Post-gestational diabetes follow-up
Key Benefits
  • Earlier detection than HbA1c alone
  • Direct measure of beta cell health
  • Enables preventive medicine at scale
  • Guides lifestyle and pharmacologic interventions
Target Users
Primary care physiciansEndocrinologistsPreventive medicine programs
Physician reviewing results on a tablet with an adult patient in exam room
Application 03

Clinical Decision Support

Intercept IQ™ integrates methylation-based molecular signals with traditional biomarkers to give clinicians a fuller picture of underlying disease biology. Results are delivered in a clinician-friendly report with risk stratification, longitudinal trends, and evidence-based interpretation to support real-world clinical workflows.

Clinical Workflow
Patient Encounter
Sample Collection
Molecular Report
Biomarker Integration
Personalized Care Plan
Real-World Use Cases
  • Ambiguous or borderline lab findings
  • Longitudinal monitoring of chronic disease
  • Personalized therapy selection
  • Risk-based screening decisions
Key Benefits
  • Complementary molecular intelligence
  • Objective, quantitative biomarkers
  • Actionable clinical reports
  • Supports precision medicine workflows
Target Users
Practicing cliniciansSpecialty medical groupsIntegrated delivery networks
Global population health screening
Application 04

Population Screening Programs

The Intercept IQ™ platform is designed to operate at population scale. From employer wellness programs to national prevention initiatives, the same core assay supports high-throughput identification of at-risk individuals — enabling health systems and public health agencies to shift resources from late-stage treatment to early intervention.

Clinical Workflow
Population Cohort
Screening Campaign
Risk Stratification
Follow-Up Testing
Preventive Programs
Real-World Use Cases
  • Employer wellness initiatives
  • Health system prevention programs
  • Community screening events
  • National public health campaigns
Key Benefits
  • Scalable across large cohorts
  • Cost-effective early identification
  • Reduces long-term disease burden
  • Data-driven resource allocation
Target Users
EmployersHealth systemsPublic health agenciesPayers
Clinical trial laboratory research
Application 05

Clinical Trial Stratification

Intercept IQ™ supports pharmaceutical and academic sponsors with biomarker-driven trial design — from smarter enrollment based on underlying beta cell biology, to longitudinal endpoints that reveal drug effect earlier and more precisely than traditional clinical measures.

Clinical Workflow
Trial Design
Biomarker-Guided Enrollment
Baseline Characterization
Longitudinal Monitoring
Endpoint Analysis
Real-World Use Cases
  • T1D disease-modifying therapy trials
  • T2D and prediabetes intervention studies
  • GLP-1 and metabolic drug trials
  • Pediatric prevention studies
Key Benefits
  • Smaller, more efficient trials
  • Objective longitudinal endpoints
  • Improved statistical power
  • Earlier signal of drug efficacy
Target Users
Pharmaceutical sponsorsCROsAcademic medical centers
Pharmaceutical development strategy
Application 06

Pharmaceutical Development

As precision medicine reshapes drug development, diagnostics become inseparable from therapeutics. Intercept IQ™ can be adapted to serve as a companion diagnostic — identifying the right patients, validating mechanism of action, and providing pharmacodynamic readouts across development phases.

Clinical Workflow
Target Identification
Biomarker Development
Phase I–III Trials
Companion Dx
Commercial Launch
Real-World Use Cases
  • Companion diagnostic co-development
  • Patient selection for precision therapies
  • Pharmacodynamic biomarker studies
  • Post-market surveillance
Key Benefits
  • Accelerated regulatory pathways
  • De-risks late-stage development
  • Enables precision labeling
  • Long-term commercial partnership
Target Users
Pharma partnersBiotech companiesRegulatory-facing programs
Endocrinologist demonstrating a GLP-1 injection pen to a patient
Application 07

GLP-1 Therapy Monitoring

GLP-1 receptor agonists have transformed metabolic care, but clinicians still lack tools to assess whether therapy is preserving underlying beta cell function. Intercept IQ™ delivers a molecular readout of beta cell status over time — helping personalize dosing, evaluate response, and quantify durable metabolic benefit.

Clinical Workflow
GLP-1 Initiation
Baseline Beta Cell Assessment
Serial Monitoring
Response Evaluation
Therapy Optimization
Real-World Use Cases
  • Baseline evaluation before GLP-1 therapy
  • Serial monitoring during treatment
  • Assessing beta cell preservation
  • Therapy discontinuation decisions
Key Benefits
  • Objective response measurement
  • Beyond weight and HbA1c
  • Personalized dosing strategies
  • Evidence of durable benefit
Target Users
EndocrinologistsObesity medicine specialistsPrimary care
Two physicians reviewing longitudinal patient biomarker trends on a monitor
Application 08

Disease Progression Monitoring

Chronic disease unfolds over years — a single test cannot capture its trajectory. Serial Intercept IQ™ testing plots the biology of disease progression over time, revealing whether a patient is stable, improving, or accelerating toward complications, and quantifying the biological impact of interventions.

Clinical Workflow
Baseline
3-Month
6-Month
12-Month
Trajectory Analysis
Real-World Use Cases
  • Long-term T1D and T2D management
  • Lifestyle intervention monitoring
  • Post-diagnosis disease trajectory
  • Complication risk assessment
Key Benefits
  • Objective longitudinal biomarker
  • Detects subtle biological trends
  • Quantifies intervention impact
  • Earlier signal of decompensation
Target Users
Chronic disease programsEndocrinology practicesValue-based care organizations
University researchers pipetting samples in a translational research lab
Application 09

Academic Research & Scientific Discovery

Kihealth partners with academic investigators, consortia, and research networks to enable translational science. Intercept IQ™ supports biomarker discovery, mechanistic studies, and multi-center collaborations spanning metabolic, autoimmune, and oncologic disease biology.

Clinical Workflow
Research Question
Cohort Design
Molecular Profiling
Data Analysis
Publication
Real-World Use Cases
  • Investigator-initiated studies
  • Multi-center research consortia
  • Translational biomarker discovery
  • Precision medicine platforms
Key Benefits
  • Access to a validated platform
  • Publication and collaboration support
  • Cross-cohort data harmonization
  • Enables next-generation science
Target Users
Academic investigatorsResearch consortiaFoundations and NIH-funded programs

Building the Future of Metabolic Intelligence.

Kihealth is building more than a diagnostic test. We are developing a platform designed to generate biological intelligence across prevention, clinical care, therapeutic innovation, research, and population health.

"The future of healthcare will be driven by earlier detection, deeper biological insight, and more informed decision-making. Kihealth intends to help power that future."

A comprehensive biomarker
dashboard for T1D interception.

Beta Intercept™ integrates methylated insulin gene cfDNA, beta cell secretory reserve, glycemic burden, and islet autoimmunity into a single longitudinal readout — engineered to detect Type 1 Diabetes years before clinical onset in pediatric patients.

Pediatric clinician reviewing screening results with an adolescent patient in a sunlit exam room

Illustrative example ·Simulated pediatric patient case shown to demonstrate how Beta Intercept™ presents results. All values and identifiers are hypothetical.

Patient Overview
Example only
Sample Patient ID
PED-2041
De-identified record number assigned to this example case
Age / Sex
8 yr · Female
Peak pediatric screening window (ages 2–10)
Family History
1st-degree relative with T1D
~15× elevated risk vs. general population
Specimen Draw Date
Jun 12, 2026
Routine annual screening visit
Panel 01

Primary Result — Percent Unmethylated INS-cfDNA

The core Beta Intercept™ measurement: the fraction of circulating insulin gene cfDNA that is unmethylated, directly quantifying ongoing beta cell death.

Primary Result
Percent Unmethylated INS-cfDNA
0.0%
Unmethylated Fraction
Interpretive Stage
Stage 2 — At Risk
Elevated
What this means

Active beta cell injury detected — years before glycemic decompensation.

An 18.4% unmethylated INS-cfDNA fraction indicates ongoing apoptosis of pancreatic beta cells. Combined with two positive islet autoantibodies (below), this patient meets criteria for Stage 2 pre-symptomatic T1D — a clinically actionable window for preventative monitoring and early intervention.

Beta Intercept™ Assay Performance
94%
Sensitivity
Correctly identifies pediatric patients with active beta cell injury
97%
Specificity
Correctly excludes children without beta cell injury (low false-positive rate)
~2 yr
Lead Time
Average time Beta Intercept™ detects disease before clinical T1D onset
Panel 02

Comprehensive Biomarker Panel

Molecular, metabolic, and autoimmune markers reported together with reference ranges, trend, and clinical significance.

Molecular Biomarkers

1 marker

cfDNA · % Unmethylated

Kihealth
Beta-cell death signal
Elevated
18.4
%
Reference < 40%

Percent unmethylated insulin gene cfDNA — directly quantifies beta cell death. An elevated fraction reflects ongoing apoptosis of pancreatic beta cells, the core molecular signal Beta Intercept™ measures.

Metabolic Panel

4 markers

Insulin

Fasting serum
Normal
12
µIU/mL
Reference 2 – 25 µIU/mL

Endogenous insulin output. Still within range — compensated secretion despite active beta cell loss.

C-Peptide

Beta cell reserve
Watch
1.4
ng/mL
Reference 1.1 – 4.4 ng/mL

Low-normal, trending down over prior draws — early signal of declining functional beta cell mass.

HbA1c

90-day glycemic average
Watch
5.9
%
Reference < 5.7%

Mild dysglycemia — subclinical glucose intolerance frequently precedes overt Stage 3 by 12–24 months.

Fasting Glucose

Plasma glucose
Normal
94
mg/dL
Reference 70 – 99 mg/dL

Normoglycemic. Fasting glucose typically remains normal until >80% of beta cell mass is lost.

Islet Autoimmunity

3 markers

GAD65 Antibody

Glutamic acid decarboxylase
Elevated
42
IU/mL
Positive ≥ 17 IU/mL

Positive — most common islet autoantibody. Confirms ongoing autoimmune attack against beta cells.

IA-2 Antibody

Tyrosine phosphatase
Elevated
28
U/mL
Positive ≥ 7.5 U/mL

Positive — high specificity for T1D. Two-antibody positivity carries >70% 10-year progression risk.

ZnT8 Antibody

Zinc transporter 8
Normal
4
U/mL
Positive ≥ 15 U/mL

Negative. Absence does not exclude progression — monitor annually as ZnT8 can seroconvert late.

Panel 03

Progression Staging

Patient position along the standard four-stage T1D progression model — Beta Intercept™ localizes disease years before Stage 3 clinical onset.

Stage 0
Genetic Risk
HLA susceptibility · no autoantibodies
Est. to onsetLifetime
Stage 1
Autoimmunity
≥ 2 islet autoantibodies · normoglycemia
Est. to onset5 – 10 yr
Current
Stage 2
Dysglycemia
≥ 2 autoantibodies + impaired glucose tolerance
Est. to onset1 – 3 yr
Stage 3
Clinical T1D
Symptomatic hyperglycemia · insulin dependence
Est. to onsetOnset
Panel 04

Clinical Interpretation & Next Steps

Actionable, evidence-based recommendations generated from the composite Beta Intercept™ result.

Refer to pediatric endocrinology

Confirm Stage 2 T1D staging; discuss disease-modifying options (e.g., teplizumab) and family education.

Serial glucose monitoring

OGTT every 6 months; consider continuous glucose monitoring for early Stage 3 conversion detection.

Repeat Beta Intercept™ in 90 days

Track methylated INS-DNA trend to quantify rate of beta cell loss and response to intervention.

DKA prevention counseling

Educate caregivers on early symptoms; ~30% of unmonitored children present in DKA at diagnosis.

Adult metabolic screening
for prediabetes and Type 2 Diabetes.

The same molecular intelligence core applied to adult populations — combining glycemic burden, beta cell secretory reserve, and proprietary molecular signals into a single composite risk score for earlier detection and risk assessment.

Physician reviewing metabolic screening results with an adult patient in a sunlit clinic

Illustrative example ·Simulated adult patient case shown to demonstrate report presentation. All values and identifiers are hypothetical.

Biomarker Dashboard
Molecular intelligence for earlier detection and risk assessment.
HbA1c
%
5.6%
Normal
Ref: <5.7%
Dec 25Feb 26Apr 26May 20
C-Peptide
ng/mL
1.45
Normal
Ref: 0.78 – 3.19
Dec 25Feb 26Apr 26May 20
Insulin
µIU/mL
7.8
Normal
Ref: 2.6 – 24.9
Dec 25Feb 26Apr 26May 20
Beta Intercept Score™
(ddPCR · INS-cfDNA)
% unmethylated
18.7%
High
Ref: <5.0% unmethylated
Dec 25Feb 26Apr 26May 20
INPUT
Molecular, clinical & patient data
  • Molecular Biomarkers
    INS-cfDNA methylation, HbA1c, C-Peptide, Insulin
  • Clinical Factors
    BMI, blood pressure, lipid panel, family history
  • Patient Data
    Age, sex, ethnicity, metabolic history
  • Preclinical Signal Data
    Longitudinal trend trajectories
  • Larger Datasets
    Population-scale reference cohorts

Results from the Kihealth CLIA laboratory.

AI-Powered Analysis
Ki Intelligence™

Integrates molecular biomarkers, clinical factors, patient data, larger datasets, and proprietary algorithms to quantify metabolic risk.

ProprietaryValidatedScalable
Output · Intercept IQ™ Score
Proprietary composite risk score
78
High Risk
Interpretation

Elevated risk for future metabolic dysfunction consistent with prediabetes physiology. Consider early intervention, lifestyle optimization, and continued monitoring.

Earlier Detection

Identify metabolic risk years before clinical onset.

Personalized Insights

Actionable intelligence for better patient outcomes.

Track Over Time

Monitor trends, lifestyle response, and therapy effect.

Empower Decisions

Data-driven guidance for patients and providers.

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