Next-generation cfDNA assay built on the Kihealth InterceptIQ™ platform expands the potential for earlier detection, dynamic disease monitoring, and precision therapeutic development in diabetes and metabolic disease.

ST. AUGUSTINE, Fla., June 5, 2026 /PRNewswire/ -- Kihealth, Inc., a precision diagnostics company focused on disease interception and metabolic health, today announced the launch of Beta Intercept™, the latest version of its proprietary beta-cell cell-free DNA (cfDNA) assay designed to detect active beta-cell injury earlier and more dynamically than traditional diabetes biomarkers.

Beta Intercept™ is built on the company's broader Kihealth Intercept™ platform, a tissue-specific cfDNA technology platform designed to measure active disease biology and cellular injury in real time across metabolic, autoimmune, oncologic, and neurodegenerative diseases.

The next-generation assay utilizes an advanced droplet digital PCR (ddPCR) platform that simultaneously evaluates three distinct methylation sites within the insulin (INS) gene, significantly improving assay specificity, signal consistency, and analytical robustness compared with prior versions. The new product also incorporates an intrachromosomal normalization strategy and enhanced methylation-sensitive restriction enzyme processing to improve reproducibility and performance across both clinical and research applications.

Key Advancements in Beta Intercept™

• Three-site INS methylation analysis
• Improved assay specificity and signal consistency
• Enhanced normalization strategy
• Improved analytical accuracy and reproducibility
• Expanded sample stability profile
• Improved suitability for longitudinal monitoring and serial testing
• Enhanced translational and clinical research applicability

"This is a major milestone for Kihealth and for the future of real-time beta-cell monitoring," said Jenna Anderson, CEO and Co-Founder of Kihealth. "For decades, clinicians have relied on biomarkers that reflect the downstream consequences of beta-cell dysfunction. Our goal is to measure the underlying biology itself. Beta Intercept™ represents another important step toward making active beta-cell injury measurable in real time and enabling earlier intervention across both Type 1 and Type 2 diabetes."

Analytical validation studies demonstrated strong performance across accuracy, precision, specificity, recovery, stability, and linearity testing. The assay achieved an average ROC AUC of 0.979 in distinguishing high-risk versus low-risk metabolic participants using average unmethylated INS cfDNA measurements across three CpG sites.

Key Validation and Translational Findings

• High-risk metabolic participants were identified with 100% sensitivity and 93.8% specificity at the 15% intermediate-risk threshold, and 85.7 sensitivity and 95.8% specificity at the 19% high-risk threshold.
• Multi-day precision studies confirmed all measurements met predefined acceptance criteria and remained within expected ranges across methylated, unmethylated, and mixed controls.
• The assay demonstrated excellent linearity across serial dilutions ranging from 2.0E+03 to 1.25 copies/µL, with average R² values greater than 0.999. The limit of detection (LOD) was established at 4.08 copies/µL.
• BLAST analysis confirmed no significant off-target amplification outside chromosome 11, while methylation-sensitive digestion selectively distinguished unmethylated from methylated DNA targets.
• Stability studies demonstrated that cfDNA remained stable for up to five days at both room temperature and refrigerated conditions (2–8°C), supporting flexible sample handling for clinical applications.

Clinical Positioning

Unlike traditional markers such as HbA1c, glucose, insulin, and C-peptide, which primarily reflect downstream metabolic consequences. Beta Intercept™ is designed to provide direct insight into active beta-cell injury. This capability may support earlier disease detection, patient stratification, therapeutic monitoring, clinical trial enrollment, and the evaluation of emerging disease-modifying therapies across Type 1 and Type 2 diabetes.

"Our vision is to move healthcare from reactive management to proactive interception," added Anderson. "We believe real-time measurement of tissue-specific disease biology has the potential to fundamentally change how chronic disease is detected, monitored, and treated."

The company is currently expanding the Kihealth Intercept™ platform across additional disease areas, including metabolic disease, immunotherapy-associated diabetes, neurodegenerative disease, autoimmune disorders, and oncology applications through ongoing research collaborations and translational studies.

About Kihealth

Kihealth is a precision diagnostics company developing advanced molecular assays designed to detect active disease biology earlier and more dynamically. The company's proprietary Kihealth Intercept™ platform leverages tissue-specific cell-free DNA biomarkers to monitor cellular injury and disease activity in real time across metabolic, autoimmune, oncologic, and neurodegenerative diseases. Kihealth operates a CLIA-certified and COLA-accredited high-complexity laboratory and is focused on transforming prevention, early detection, and therapeutic monitoring through next-generation molecular diagnostics.

Media Contact:
Kihealth, Inc.
press@kihealth.com
www.kihealth.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/kihealth-announces-launch-of-beta-intercept-advancing-real-time-detection-of-diabetes-302790425.html

SOURCE Kihealth