Kihealth Labs · Precision Oncology
Onco Intercept™
Early molecular detection for pancreatic cancer.
Powered by the Intercept IQ™ platform, Onco Intercept combines liquid biopsy, cell-free DNA, epigenetic biomarkers, proteomics, and artificial intelligence to detect molecular evidence of pancreatic cancer before traditional clinical presentation.
The Clinical Need
Why pancreatic cancer?
Pancreatic cancer remains one of the deadliest cancers because it is usually diagnosed after curative treatment is no longer possible.
5th
leading cause of cancer-related death in the U.S.
<15%
five-year survival across all stages
~80%
of patients present with unresectable or metastatic disease
Only ~20%
of patients are eligible for potentially curative resection at diagnosis
Progression of Disease
From healthy tissue to metastatic disease.
Current diagnostics identify disease too late — after the window for curative intervention has closed.
Healthy Pancreas
Normal acinar and ductal architecture.
Precancerous Changes
PanIN lesions and low-grade dysplasia begin silently.
Localized Cancer
Confined to the pancreas — still potentially resectable.
Regional Spread
Local invasion and lymph node involvement.
Metastatic Disease
Distant spread; curative options exhausted.
Earlier detection represents one of the greatest unmet needs in oncology — and the strategic entry point for the Intercept IQ™ platform.
Disease Biology
The biology of pancreatic cancer.
Cancer develops gradually through years of accumulated molecular alterations long before imaging abnormalities become apparent.
- 1
Normal Pancreatic Biology
Healthy acinar and ductal cells maintain exocrine and endocrine function.
- 2
Inflammation
Chronic pancreatitis and cytokine signaling create a permissive microenvironment.
- 3
Acinar-to-Ductal Metaplasia
Acinar cells reprogram to a ductal-like phenotype.
- 4
PanIN Lesions
Pancreatic intraepithelial neoplasia — the earliest recognized precursor.
- 5
Genomic Instability
Progressive KRAS, TP53, CDKN2A, and SMAD4 alterations accumulate.
- 6
Early Tumor Development
Localized invasive adenocarcinoma emerges from precursor lesions.
- 7
Progressive Invasion
Local stromal invasion and lymphatic spread.
- 8
Metastasis
Hematogenous spread to liver, peritoneum, and beyond.
Liquid Biopsy Biology
Molecular signals released by early tumors.
Even very small tumors release measurable biological signals into circulation that can be captured through advanced liquid biopsy technologies.
Cell-Free DNA
Fragmented DNA shed by dying tumor and stromal cells.
Tumor Methylation
Tissue- and tumor-specific epigenetic signatures.
Mutated DNA Fragments
KRAS, TP53, and other driver mutations in circulation.
Protein Biomarkers
Secreted and shed tumor-associated proteins.
Inflammatory Proteins
Host inflammatory and stromal response signals.
Extracellular Vesicles
Exosomes carrying tumor RNA, protein, and lipid cargo.
Immune Response
Circulating cytokines and immune cell profiles.
The Platform
The Onco Intercept™ workflow.
Rather than relying on a single biomarker, Onco Intercept integrates multiple complementary biological signals to improve diagnostic performance.
Blood Collection
Standard peripheral venipuncture; no invasive tissue biopsy.
Plasma Processing
Controlled fractionation preserves fragile cfDNA and proteins.
cfDNA Extraction
High-yield, low-input capture of circulating fragments.
Epigenetic Analysis
Tissue- and tumor-specific methylation profiling.
Proteomic Assessment
Complementary protein and inflammatory signatures.
AI Pattern Recognition
Machine learning integrates orthogonal molecular signals.
Integrated Risk Score
Unified molecular risk score for pancreatic cancer.
Clinical Report
Actionable, interpretive report for the ordering provider.
Multi-Omic Intelligence
A more complete picture of tumor biology.
Integrating orthogonal molecular data provides a richer view of disease biology than any individual analyte — the foundation of the Intercept IQ™ approach to oncology.
Central Model
Pancreatic Cancer Biology
Genomics
Epigenomics
Proteomics
Inflammatory Biology
Clinical Metadata
Longitudinal Data
Machine Learning
Orthogonal data, one model
Genomic, epigenomic, proteomic, and inflammatory signals capture different aspects of tumor biology and host response.
Longitudinal by design
Serial measurements convert isolated data points into a dynamic view of disease trajectory.
AI-native integration
Machine learning identifies multidimensional signatures no single analyte can reveal.
Artificial Intelligence
Translating complex molecular data into actionable clinical insights.
The Intercept IQ™ platform applies machine learning to convert high-dimensional multi-omic signals into interpretable clinical outputs.
- Detect multidimensional molecular signatures
- Identify subtle biomarker relationships
- Improve predictive performance
- Generate individualized molecular risk assessments
- Continuously improve as clinical data accrue
Analytical Pipeline
- 01Raw Molecular Data
- 02Quality Control
- 03AI Analysis
- 04Risk Classification
- 05Clinical Decision Support
Intended Clinical Applications
Where Onco Intercept™ fits in the care pathway.
From high-risk screening to post-treatment surveillance and pharmaceutical development, Onco Intercept is designed to support decisions across the pancreatic cancer continuum.
High-Risk Patient Screening
Molecular surveillance for elevated-risk populations.
- Family history of pancreatic cancer
- Chronic pancreatitis
- New-onset diabetes after age 50
- Genetic predisposition (BRCA1/2, PALB2, others)
- Pancreatic cyst surveillance
Earlier Diagnostic Evaluation
Support evaluation of patients presenting with suspicious symptoms or indeterminate imaging findings.
Treatment Monitoring
Monitor molecular response following:
- Surgery
- Chemotherapy
- Radiation
- Targeted therapy
- Immunotherapy
Disease Surveillance
Monitor recurrence following potentially curative treatment.
Pharmaceutical Clinical Trials
Enable precision-oncology development:
- Patient stratification
- Companion diagnostics
- Enrollment enrichment
- Biomarker endpoints
- Therapeutic response monitoring
Development Strategy
A rigorous path from discovery to clinical launch.
Onco Intercept™ is being developed through a disciplined, phased pipeline aligned to clinical and regulatory standards for high-consequence oncology diagnostics.
Discovery
Cohort assembly, biomarker candidate identification.
Biomarker Identification
Prioritization of proprietary methylation, protein, and multi-omic signatures.
Analytical Validation
Precision, accuracy, LoD, and reproducibility studies.
Clinical Validation
Case-control and prospective validation across intended-use populations.
Regulatory Studies
IDE / LDT / IVD pathway execution aligned to intended use.
Commercial Launch
Kihealth CLIA laboratory deployment and clinical availability.
Current Focus
Identification and validation of proprietary molecular biomarker signatures associated with early pancreatic cancer, and integration into the Intercept IQ™ multi-omic classifier.
Why Multi-Omics Matters
Traditional biomarkers vs. Onco Intercept™.
Single-analyte assays miss the biology. A multi-omic, longitudinal approach captures the complexity of early tumor biology.
Future Oncology Pipeline
A platform, not a single assay.
The Intercept IQ™ platform is designed as a scalable molecular diagnostic architecture capable of expanding across multiple oncology applications.
Lead Program
Pancreatic Cancer
Discovery
Hepatobiliary Disease
Discovery
Colorectal Cancer
Exploration
Lung Cancer
Roadmap
Additional Solid Tumors
Additional pipeline programs shown are illustrative of the platform's expansion roadmap.
Research & Clinical Partnerships
Building a scientific network around Onco Intercept™.
Onco Intercept™ is being developed alongside a network of institutions and partners spanning discovery, validation, and clinical deployment.
Illustrative network representation.
Academic Institutions
Translational science and biomarker discovery.
Cancer Centers
Clinical validation cohorts and intended-use populations.
Biopharmaceutical Partners
Companion diagnostics and trial enrichment.
Clinical Research Organizations
Multi-site study execution and quality.
Reference Laboratories
Analytical harmonization and orthogonal validation.
Building the future of early cancer detection
Earlier detection. Better decisions. Improved outcomes.
Onco Intercept™ represents Kihealth's expansion of the Intercept IQ™ platform into oncology — combining advanced liquid biopsy technologies, multi-omic biomarker discovery, and artificial intelligence to develop next-generation diagnostics for pancreatic cancer. By identifying molecular evidence of disease before conventional diagnosis, Onco Intercept aims to support earlier intervention, improve clinical decision-making, and advance precision oncology.