Clinician discussing type 2 diabetes care options with a patient in a bright clinical exam room

Detect Active Beta Cell Loss Before Traditional Diabetes Tests Reveal the Full Story

Beta Intercept™ T2D measures circulating beta-cell-specific cell-free DNA (cfDNA) released during apoptosis, providing a direct biological indicator of pancreatic injury and beta-cell loss before conventional biomarkers fully reflect disease progression.

Single blood drawBeta-cell-specific INS cfDNADigital PCR quantification
THE GAP IN CURRENT TESTING

Traditional tests measure consequences. Beta Intercept measures biology.

When each marker becomes abnormal
Illustrative · disease course →
HbA1c
Fasting Glucose
Insulin
Beta Intercept™
Metabolically healthyPrediabetesClinical T2D

Glucose-based markers report the downstream consequence of beta-cell loss. Beta Intercept™ reports the loss itself — while the pancreatic reserve that remains is still worth protecting.

THE BIOLOGY OF TYPE 2 DIABETES

From insulin resistance to beta cell failure.

Type 2 diabetes is not a sudden event. It is a progressive metabolic cascade in which beta cells compensate, exhaust, and ultimately die — long before a diagnostic threshold is crossed.

CompensationCellular stressActive beta-cell lossClinical disease
01
Illustration of insulin molecules unable to engage receptors on a cell membrane while glucose accumulates
Compensation
Insulin Resistance

Muscle, liver, and adipose tissue respond less efficiently to insulin, raising the secretory demand placed on the pancreas.

02
Illustration of beta cells releasing dense clouds of insulin granules into a blood vessel
Compensation
Hyperinsulinemia

Beta cells compensate by secreting more insulin. Glucose stays near-normal while the underlying workload climbs.

03
Illustration of a stressed beta cell with swollen endoplasmic reticulum and lipid droplets
Cellular stress
Metabolic Stress

Sustained glucose and lipid load strains the beta-cell secretory machinery — endoplasmic reticulum and oxidative stress accumulate.

04
Illustration of fragmented mitochondria with disrupted cristae inside a cell
Cellular stress
Mitochondrial Dysfunction

Energy production falters. Impaired glucose sensing and reduced ATP output degrade the precision of insulin release.

05
Illustration of a pancreatic islet infiltrated by macrophages and inflammatory particles
Cellular stress
Islet Inflammation

Low-grade inflammatory signaling within the islet amplifies injury and accelerates the transition toward cell death.

06
Illustration of beta cells shrinking and fragmenting into apoptotic bodies
Active beta-cell loss
Progressive Beta Cell Apoptosis

Stressed beta cells begin dying. Functional beta-cell mass declines while glucose measurements may still appear acceptable.

07
Illustration of cell-free DNA fragments released from a fragmenting cell into the bloodstream
Active beta-cell loss
Release of Beta Cell cfDNA

Dying beta cells shed fragments of demethylated INS cell-free DNA into circulation — the signal Beta Intercept™ quantifies.

08
Illustration of a depleted pancreatic islet with sparse insulin granules
Active beta-cell loss
Declining Insulin Production

With reduced beta-cell mass, secretory capacity falls and postprandial control deteriorates.

09
Illustration of a blood vessel crowded with glucose alongside a diminished pancreas
Clinical disease
Clinical Type 2 Diabetes

Hyperglycemia crosses diagnostic thresholds — years after the underlying beta-cell attrition began.

Beta Intercept™ T2D reads the cascade at the point of cellular injury rather than waiting for the glycemic consequences of stages eight and nine.
WHAT WE MEASURE

Four biomarkers. One comprehensive view of beta cell health.

Beta Intercept™ T2D integrates four complementary biomarkers to evaluate active beta-cell injury, insulin production, and glycemic control—providing a more complete assessment of metabolic health than any individual marker alone.

Primary Biomarker

Beta Score™

Direct Measure of Active Beta Cell Death

Measures circulating unmethylated beta-cell-derived cfDNA released during apoptosis, providing a direct biological signal of ongoing pancreatic beta-cell injury.

Measures
  • Active beta-cell apoptosis
  • Real-time pancreatic injury
  • Disease activity
  • Longitudinal beta-cell preservation

DNA strand resolving into digital biomarker particles

Complementary

Insulin

Current Insulin Production

Measures circulating insulin concentrations to evaluate endogenous insulin secretion and metabolic demand.

Provides insight into
  • Hyperinsulinemia
  • Insulin secretion
  • Early compensation
  • Beta-cell function

Insulin molecule engaging its receptor

Complementary

C-Peptide

Endogenous Beta Cell Function

Measures C-peptide released during endogenous insulin production to estimate remaining functional beta-cell capacity.

Provides insight into
  • Residual beta-cell reserve
  • Endogenous insulin production
  • Functional pancreatic capacity
  • Disease progression

Pancreatic islet with secretion pathway

Complementary

HbA1c

Long-Term Glycemic Control

Measures average blood glucose over approximately three months, reflecting cumulative glycemic exposure.

Provides insight into
  • Long-term glucose control
  • Treatment response
  • Glycemic trends
  • Metabolic status

Red blood cell surrounded by glucose molecules

Beta Intercept™ T2D

Comprehensive Beta Cell Intelligence

Direct Injury
Beta Score™
Functional Capacity
C-Peptide
Insulin Production
Insulin
Glycemic Control
HbA1c
More Complete Clinical Insight

A Multi-Dimensional Assessment of Metabolic Health

No single biomarker fully captures the progression of Type 2 diabetes. Beta Intercept™ T2D combines direct measurement of active beta-cell injury (Beta Score™) with insulin, C-peptide, and HbA1c to provide a comprehensive view of pancreatic health, beta-cell function, and metabolic status.

WHY BETA CELL DEATH MATTERS

Beta-cell mass is the reserve that determines the course of the disease.

Loss of Functional Beta Cell Mass

Progressive apoptosis reduces insulin-producing capacity and diminishes pancreatic reserve.

Disease Progression

Ongoing beta-cell loss contributes to worsening glycemic control and disease advancement long before many patients require insulin therapy.

Earlier Intervention

Direct measurement of beta-cell apoptosis may identify disease progression while therapeutic intervention has greater potential to preserve remaining beta-cell function.

From Blood Sample to Biological Intelligence

Every Kihealth Labs result begins with a simple blood draw and progresses through a highly advanced molecular workflow designed to preserve biological integrity, quantify beta-cell injury, and transform complex molecular signals into clinically actionable intelligence.

  1. 01

    Patient Evaluation

    Clinical indication and informed consent

    Physician with a tablet discussing testing options with a patient in a bright clinic office
  2. 02

    Blood Collection

    Single standard venous draw

    Gloved hand holding a Kihealth-labeled tube of collected whole blood in a clinical laboratory
  3. 03

    Plasma Preparation

    Centrifugation and plasma isolation

    Blood tube showing separated plasma, buffy coat, and red blood cells beside a laboratory centrifuge
  4. 04

    Cell-Free DNA Extraction

    Isolation of circulating cfDNA from plasma

    Laboratory pipette transferring liquid for cell-free DNA extraction
  5. 05

    Bisulfite-Free Methylation Analysis

    Preserves fragile cfDNA and methylation signal

    Laboratory analyzer with DNA methylation signal visualization and data readout
  6. 06

    Droplet Digital PCR

    Bio-Rad platform for absolute quantification

    Bio-Rad droplet digital PCR instrument with analysis touchscreen
  7. 07

    Ki Intelligence AI Analysis

    Intercept IQ™ contextual interpretation

    Scientist reviewing a Ki Intelligence multi-omic AI analysis dashboard
  8. 08

    Clinical Report

    Actionable, longitudinal output

    Physician reviewing a Kihealth Labs clinical report on a tablet

Minimally Invasive

Simple blood draw

Highly Precise

Beta-cell-specific detection

Early Insight

Detects change before symptoms

Clinically Actionable

Real data. Real decisions.

Longitudinal Value

Track. Monitor. Intervene.

CLINICAL APPLICATIONS

Designed for modern metabolic medicine.

Every setting below asks a different clinical question. Beta Score™ answers all of them from the same standard blood draw.

1
Blood draw
10
Care settings
3
Decision layers
01 — Detect

Find beta cell injury before glucose moves

HbA1c and fasting glucose report damage that has already accumulated. Beta Score™ reports injury while it is still happening.

  • Early Detection
    Is beta cell loss active right now?

    Flags unmethylated INS cfDNA release in patients whose glucose panels still read normal.

    Years ahead of HbA1c drift
  • Prediabetes Risk Assessment
    Which prediabetic patient converts next?

    Separates stable insulin resistance from patients with ongoing beta cell attrition.

    Stratifies a 1-in-3 population
  • Population Health
    Where should screening dollars go?

    A single blood draw ranks cohorts by active injury instead of by claims history.

    Cohort-level triage
02 — Care

Built into the settings where metabolic disease is managed

One venous draw, standard phlebotomy, results returned in a report clinicians can read in under a minute.

  • Primary Care
    Who needs escalation today?

    Adds an actionable beta cell readout to the annual metabolic panel with no new workflow.

    Routine draw, no prep
  • Endocrinology
    Is the current regimen preserving function?

    Serial Beta Score™ trends show whether therapy is protecting remaining beta cell mass.

    Serial trend monitoring
  • Functional Medicine
    Is the protocol actually changing biology?

    Objective molecular evidence to anchor nutrition, sleep, and metabolic interventions.

    Objective endpoint
  • Longevity Clinics
    How is metabolic reserve aging?

    Tracks organ-level beta cell resilience alongside existing longevity biomarker panels.

    Reserve over time
03 — Treat & Scale

Proof that an intervention is working — earlier

Weight and HbA1c take quarters to move. Beta cell injury responds first, giving programs a near-term signal of benefit.

  • GLP-1 Programs
    Is this patient responding beyond weight?

    Distinguishes true beta cell protection from weight loss alone during titration.

    Early response marker
  • Weight Management Clinics
    What justifies continued therapy?

    Gives programs a metabolic outcome to report when the scale plateaus.

    Retention-grade evidence
  • Employer Health Programs
    Is the benefit spend returning anything?

    Measures program impact on the disease driver, not just engagement metrics.

    Outcome accountability
Research and therapeutic development team collaborating in the lab
RESEARCH & THERAPEUTIC DEVELOPMENT

Bringing Beta Intercept into drug development.

For sponsors developing infusion therapies, drugs, implants, and regenerative interventions, Beta Intercept™ T2D delivers a direct measure of beta-cell injury that transforms how trials are designed, enrolled, and evaluated.

Better Patient Selection
Enrich enrollment with patients whose beta cells are still active and functional — the exact population most likely to respond to a beta-cell-preserving or beta-cell-restoring therapy.
Improved Outcomes
When the right patients are in the study, response rates rise. Sponsors see cleaner signals, fewer null results driven by wrong-patient enrollment, and stronger efficacy data.
An Extra Endpoint
Beta Score™ adds a direct measure of beta-cell injury alongside standard glucose, HbA1c, and C-peptide endpoints — giving sponsors a mechanistic readout that glucose alone can't provide.
Deeper Beta-Cell Intelligence
Serial measurements track whether a therapy is protecting beta cells in real time — information about beta-cell function that no conventional metabolic biomarker reveals.
How the partnership works
  1. 1
    Therapeutic Development
    Sponsors developing infusion therapies, oral drugs, implants, or cell-based interventions partner with Kihealth to integrate Beta Intercept™ into their trial design.
  2. 2
    Enriched Patient Enrollment
    Beta Intercept™ screens candidates for active, functioning beta cells — ensuring the right patients enter the study. Enrolling patients with viable beta-cell mass increases the likelihood of detecting a therapeutic signal.
  3. 3
    Baseline Biomarker Measurement
    Each enrolled patient receives a baseline Beta Score™ — a direct, quantitative measure of active beta-cell injury before treatment begins.
  4. 4
    Therapeutic Intervention
    The investigational therapy is administered while serial blood draws capture Beta Score™ at protocol-defined intervals throughout the study.
  5. 5
    Serial Monitoring & Endpoint Analysis
    Longitudinal Beta Score™ trajectories reveal whether the treatment is preserving, restoring, or failing to protect beta cells — an extra endpoint beyond glucose-based metrics.
  6. 6
    Mechanistic Evidence & Regulatory Support
    Direct cellular-injury data strengthens proof-of-mechanism, supports companion-diagnostic strategies, and gives sponsors a richer dataset for regulatory submissions.
Therapy areas we support
  • Infusion therapies
  • Oral small-molecule drugs
  • Beta-cell implants & encapsulation devices
  • Stem-cell & regenerative therapies
  • GLP-1 and incretin-based treatments
  • Immunomodulatory interventions
The right patients. Cleaner signals. Better data.

Adding Beta Intercept™ to a study means enrolling patients with active, functioning beta cells — the population most likely to respond. It means an extra endpoint that measures beta-cell injury directly. And it means richer, mechanistic evidence that strengthens every submission.

Beta Intercept™ T2D

Detect beta cell loss earlier. Make more informed clinical decisions.

Beta Intercept™ T2D provides a direct biological measure of beta-cell injury, helping clinicians, researchers, and therapeutic developers better understand disease progression and evaluate interventions before traditional biomarkers fully capture change.