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.

1
Unified Platform
4+
Disease Programs
cfDNA
Single Blood Sample
Platform Architecture

Intercept IQ™ Platform

One Platform. Multiple Disease-Specific Diagnostics.

Every Kihealth diagnostic is built from the same proprietary molecular engine — tuned for a specific disease, patient population, and clinical workflow. Kihealth is a platform company, not a collection of unrelated products.

Core Platform
Intercept IQ™
Proprietary Molecular Diagnostics Platform
Type 1 DiabetesAvailable

BetaIntercept™ T1D

Early detection and longitudinal monitoring of Type 1 Diabetes through beta-cell derived cfDNA.

Type 2 DiabetesAvailable

BetaIntercept™ T2D

Detection and monitoring of progressive beta-cell dysfunction in Type 2 Diabetes.

OncologyIn Development

OncoIntercept™

Blood-based molecular diagnostics for pancreatic cancer and future oncology applications.

Neurodegenerative DiseaseIn Development

NeuroIntercept™

Blood-based molecular diagnostics supporting earlier detection of Alzheimer's and future neurodegenerative disorders.

Kihealth Ecosystem

Intercept IQ™ powers products across every arm of the Kihealth family.

Kihealth LabsProviderKicaresKihealth EuropeKilumaKivara
Applications

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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Deep Dive

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

BetaIntercept™ 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. BetaIntercept™ 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
The Ecosystem

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."

Intercept IQ™ · Multi-Application Platform

From a single tube of blood to actionable molecular intelligence.

Six tightly coupled stages convert routine plasma into a CLIA-grade readout of active disease biology. Scroll to walk the pipeline.

PHLEBOTOMY0%

Blood Sample

A single standard Norgen tube. No imaging, no biopsy, no specialized collection.

Volume
10 mL
Visit
Outpatient

Liquid Biopsy

Centrifugation separates plasma from cellular components within minutes of draw, preserving fragile cell-free signal.

Sample
1 mL of plasma
Processing time
8 hours

Cell-Free DNA

Sub-nanogram cfDNA fragments — released by dying cells across every tissue — are captured and prepared for deep sequencing.

Input
< 1 ng cfDNA
Fragment size
~166 bp

Epigenetic Analysis

30–120× whole-genome bisulfite sequencing resolves methylation, fragmentomic, and end-motif signatures unique to each tissue and disease state.

Depth
30–120×
Sites profiled
28M CpG

Molecular Intelligence

Multi-task models trained on hundreds of thousands of prospectively collected samples infer tissue-of-origin and active disease biology from 2.4M features per sample.

Features
2.4M / sample
Sensitivity
94% at stage I

Actionable Clinical Insights

Physician-facing reports surface tissue-of-origin, disease state, and confidence — backed by analytical and clinical validation, in language clinicians act on.

Turnaround
10 days
Report format
CLIA-grade

Detected at the molecular signal — years before symptoms.

Disease begins as cellular injury, becomes molecular change, then biomarker shift, then symptom. InterceptIQ™ reads the molecular signal at the moment of cellular injury — long before any clinical test would register a result.

Disease interception timeline: healthy cell, cellular injury releasing cfDNA, InterceptIQ detection at the molecular moment, symptomatic cell, late-stage diagnosis
Healthy
Cellular baseline
Injury
cfDNA shed
Intercept
Signal read
Symptom
Function loss
Diagnosis
Late stage

Where InterceptIQ™ sees disease that conventional testing cannot.

The natural history of Type 1 Diabetes plotted along its molecular and clinical timeline. cfDNA signal rises the moment β-cells begin to die — years before HbA1c moves.

−5y
−3y
−1y
Onset
Dx
01
Healthy State

Homeostasis

02
Cellular Injury

Autoimmune attack begins

03
Molecular Changes

cfDNA signal rises

04
Biomarker Changes

Autoantibodies appear

05
Symptoms

Hyperglycemia, polyuria, weight loss

06
Clinical Diagnosis

HbA1c, fasting glucose, OGTT

Earliest detection by modality
Disease interception window
InterceptIQ detects ~1–3 years earlier
Selected modality

InterceptIQ™

cfDNA β-cell methylation

Lead time vs symptom onset

Years 1–3 before symptoms

Natural history · Type 1 Diabetes
  1. 01Healthy State

    Pancreatic islet β-cells maintain insulin secretion. No autoimmune activity, no measurable tissue injury.

  2. 02Cellular Injury

    T-cell infiltration triggers β-cell apoptosis. Dying cells release fragments of methylated DNA into circulation.

  3. 03Molecular Changes

    Unmethylated INS gene cfDNA fragments and β-cell-specific methylation marks accumulate in plasma — years before glucose dysregulation.

  4. 04Biomarker Changes

    GAD65, IA-2, and ZnT8 autoantibodies become detectable. β-cell mass loss accelerates past 50%.

  5. 05Symptoms

    Clinical symptoms emerge once functional β-cell reserve is largely exhausted. Patient presents to primary care.

  6. 06Clinical Diagnosis

    Standard-of-care diagnosis confirms T1D. By this point, >80% of β-cell mass is irreversibly lost.

Illustrative T1D natural history. Lead-time estimates supported by Akirav et al., Herold et al., and ongoing prospective InterceptIQ™ cohorts. Indicative — not for diagnostic use.

The InterceptIQ pipeline is a continuous instrument loop. Every stage is quality-controlled, traceable, and engineered to preserve fragmentomic detail from picogram-level input through clinical reporting.

01Blood draw02cfDNA capture03Sequencing04Methylation atlas05AI inference06Clinical report

Every dying cell leaves a fingerprint in the bloodstream.

Cells release small fragments of DNA into circulation as they die. These fragments — cell-free DNA — carry methylation, length, and end-motif patterns that betray the tissue they came from and the biological process that produced them. InterceptIQ reads that signal at single-molecule resolution.
01

Capture

Proprietary low-input library chemistry preserves fragmentomic detail from <1 ng of cfDNA.

02

Sequence

Deep whole-genome bisulfite sequencing at 30×–120×, scaled across hundreds of thousands of samples.

03

Interpret

Federated AI infers tissue-of-origin and disease state from 2.4M features per sample.

Five tightly coupled layers — wet lab to clinical report — each instrumented, quality-controlled, and engineered for regulatory and payer review.

Samples processed (lifetime)1,200
Reads streaming (Gb/s)12.40
Inferences today1,283

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.

INS · Chromosome 11p15.5 · bisulfite-converted track
Δ from TSS (bp)
−500−250TSS+250+500
Exon 1Exon 2Exon 3TSSINS -233upstreamINS -135proximalINS +399intragenic
INS -233w = 0.34
81%
Unmethylated · β-cell

Open chromatin in pancreatic β-cells; hypermethylated in non-β tissue.

Promoter · upstream
INS -135w = 0.33
74%
Unmethylated · β-cell

β-cell specific demethylation; conserved across human islet donors.

Promoter · proximal
INS +399w = 0.33
69%
Unmethylated · β-cell

Independent confirmatory locus; lowers false-positive rate vs. single-site assays.

Exon 2 · intragenic
InterceptIQ™ score
74.7
Joint disease intelligence

Calibrated weighted combination — auditable, interpretable, and reproducible across cohorts.

Calibrated · AUC 0.979 · n = 1,847

Models that learn biology, not noise.

Our models are trained on prospectively collected, IRB-approved cohorts and audited for confounding, leakage, and demographic generalization. Every classifier ships with an interpretability layer that maps predictions back to biological features — critical for regulatory review and clinician trust.

See peer-reviewed methods →
# InterceptIQ inference
model = InterceptIQ.load("v4.2-multitask")
sample = cfDNA.from_plasma("KH-PLT-0421")
result = model.predict(sample)
→ tissue_signal: pancreatic_islet (0.87)
→ disease_state: T1D_active (0.92)
→ confidence: high (calibrated)
→ features_attributed: 1,847

What clinicians actually see — a calibrated, auditable signal.

Sample KH-PLT-0421 · synthetic readout for illustration

InterceptIQ · live console
KH-PLT-0421 · 2026-06-03

Tissue-of-origin

Methylation atlas

47 cell types

Pancreatic islet β-cell87%
Hepatocyte41%
Cortical neuron23%
Ductal epithelium18%
Lymphocyte (baseline)9%

Fragmentomic readout

cfDNA · bp

100167320
baseline
tumor-shed

Methylation grid · chr11

0%100%
00:00sample KH-PLT-0421 ingested