Academic Partnerships
Formal research collaborations with leading hospitals, universities, and research institutions to co-develop rigorous clinical evidence.
Clinical Research
Advancing Precision Diagnostics Through Clinical Research
KiHealth collaborates with leading academic medical centers, healthcare systems, and clinical investigators to validate next-generation molecular diagnostics for earlier disease detection, risk stratification, and precision medicine.
Why Clinical Research Matters
Evidence is the bridge between molecular discovery and clinical practice.
Innovative diagnostics change medicine only when their performance is validated with the same rigor demanded of a therapeutic. KiHealth Labs treats clinical evidence generation as a core scientific discipline — with prospective study design, multi-site analytical validation, and longitudinal biomarker monitoring built into every program from its earliest stages.
This is the standard required by physicians, health systems, regulators, and payers — and it is the foundation on which durable precision diagnostics are built.
Clinical Validation
Prospective studies demonstrating that a diagnostic performs reliably in the intended patient populations and care settings.
Analytical Validation
Rigorous characterization of assay accuracy, precision, sensitivity, specificity, and reproducibility across sites.
Biomarker Discovery
Identification and qualification of molecular signals that reflect underlying disease biology with clinical relevance.
Prospective Studies
IRB-approved, hypothesis-driven cohorts designed from day one to generate publishable, decision-grade evidence.
Longitudinal Monitoring
Repeated biomarker sampling across disease trajectories to detect early transitions before overt clinical change.
Regulatory Readiness
Evidence packages structured for future regulatory submissions and payer and health-system adoption.
Our Clinical Research Platform
A vertically integrated research infrastructure
KiHealth Labs operates a full-stack research platform designed to move a molecular hypothesis from bench to bedside without the fragmentation that slows most diagnostic programs.
Prospective Clinical Studies
Carefully designed observational and interventional studies that generate high-quality, publication-ready evidence with predefined endpoints.
Translational Medicine
Bridging laboratory discoveries into clinically actionable diagnostics through structured translational programs and clinician partnerships.
Regulatory Evidence Generation
Building the analytical and clinical evidence packages required for future regulatory submissions, guideline inclusion, and commercial adoption.
Research Focus Areas
The scientific frontiers we study
Type 1 Diabetes
Type 2 Diabetes
Beta Cell Biology
Beta Cell Death
Prediabetes
Obesity & Metabolic Disease
Precision Medicine
Biomarker Discovery
Liquid Biopsy
Molecular Diagnostics
Longitudinal Disease Monitoring
AI-Enabled Clinical Analytics
Current Clinical Studies
Active and forthcoming research programs
KiHealth Labs' study portfolio spans early feasibility work, prospective analytical and clinical validation, and longitudinal cohorts designed to generate durable clinical evidence.
Type 1 Diabetes / Beta Cell Biology
RecruitingPediatric Beta Cell Health Study
Study Design
Prospective, multi-center observational cohort
Enrollment Target
Target: 500 pediatric participants
Collaborating Institutions
Leading pediatric academic medical centers (multi-site)
Disease Area
Type 1 Diabetes / Beta Cell Biology
Objectives
Characterize longitudinal patterns of beta cell health biomarkers in children at genetic and immunologic risk for T1D, and evaluate the ability of blood-based beta cell signals to identify early disease transitions.
Primary Endpoints
- Longitudinal change in circulating beta cell death signal
- Association with autoantibody status and glycemic markers
- Time-to-clinical T1D in high-risk stratum
Type 1 & Type 2 Diabetes
ActiveBetaDx™ Clinical Validation Program
Study Design
Multi-cohort analytical and clinical validation study
Enrollment Target
Target: 1,200 adult and pediatric participants
Collaborating Institutions
Academic diabetes centers and reference laboratories
Disease Area
Type 1 & Type 2 Diabetes
Objectives
Establish the analytical performance and clinical validity of the BetaDx™ blood-based beta cell health assay across diverse patient populations and clinical contexts.
Primary Endpoints
- Analytical sensitivity, specificity, precision, and reproducibility
- Clinical sensitivity vs reference standards
- Cross-site reproducibility across CLIA-grade laboratories
Prediabetes / Metabolic Disease
In DevelopmentLongitudinal Metabolic Monitoring Study
Study Design
Prospective longitudinal cohort with quarterly biomarker sampling
Enrollment Target
Target: 800 adults with metabolic risk factors
Collaborating Institutions
Health system partners across multiple regions
Disease Area
Prediabetes / Metabolic Disease
Objectives
Evaluate whether serial molecular biomarker monitoring can detect metabolic disease progression earlier than traditional glycemic and lipid markers.
Primary Endpoints
- Time-to-detection of metabolic transition vs standard care
- Trajectory modeling of beta cell and hepatic signals
- Concordance with continuous glucose and metabolic phenotyping
Pancreatic Cancer / High-Risk Surveillance
PlanningPancreatic Cancer Biomarker Feasibility Study
Study Design
Prospective feasibility study in high-risk surveillance cohorts
Enrollment Target
Target: 300 high-risk adults
Collaborating Institutions
Comprehensive cancer centers with active pancreatic surveillance programs
Disease Area
Pancreatic Cancer / High-Risk Surveillance
Objectives
Assess the feasibility of a blood-based liquid biopsy approach for early detection signal in individuals under active pancreatic surveillance.
Primary Endpoints
- Assay performance in high-risk surveillance context
- Concordance with EUS/MRI surveillance findings
- Operational feasibility across surveillance sites
Completed & Published Research
Publications and evidence artifacts
As KiHealth Labs' clinical programs reach publication milestones, results will appear here alongside preprints, abstracts, and technical white papers.
Peer-Reviewed Manuscript
Clinical Validation Manuscript
Primary clinical validation results from KiHealth's beta cell health program, currently being prepared for submission to a leading peer-reviewed journal.
In Preparation
White Paper
BetaDx™ White Paper
Technical overview of BetaDx™ — assay chemistry, analytical performance, and clinical validation strategy — targeted for release alongside the program's first clinical milestone.
Coming Soon
Scientific Abstract
Scientific Abstract
Abstract of early longitudinal findings targeted for submission to a major diabetes scientific meeting.
In Development
Research Network
A collaborative network built for rigorous evidence generation
Our research is conducted in partnership with the institutions that see patients, run laboratories, and shape clinical practice.
Academic Medical Centers
Children's Hospitals
Healthcare Systems
Clinical Research Sites
Reference Laboratories
Industry Partners
Clinical Research Process
From molecular discovery to real-world clinical evidence
Every KiHealth diagnostic advances through a defined, auditable sequence of scientific and clinical milestones.
- 01StepScientific Discovery
- 02StepBiomarker Identification
- 03StepAssay Development
- 04StepAnalytical Validation
- 05StepClinical Validation
- 06StepMulti-Site Clinical Studies
- 07StepRegulatory Evidence
- 08StepCommercial Deployment
- 09StepReal-World Clinical Evidence
Impact Metrics
Our clinical research footprint
A growing portfolio of studies, sites, and collaborators supporting the development of interception-grade diagnostics.
4+
Active Clinical Studies
10+
Research Sites
2,800+
Patients Targeted for Enrollment
12+
Academic Collaborators
5
Disease Programs
Growing
Scientific Publications
Participate in Research
Build the evidence base for the next generation of precision diagnostics.
KiHealth Labs partners with investigators, healthcare systems, academic researchers, and pharmaceutical and biotechnology companies to design and execute clinical studies that meet the highest standards of scientific and regulatory rigor.
Investigators•Healthcare Systems•Academic Researchers•Pharmaceutical Companies•Biotechnology Partners