Kihealth Inc., a precision diagnostics company, has closed a $5 million oversubscribed seed funding round to support the commercial rollout of its first-of-its-kind laboratory-developed test that measures biomarkers of beta cell apoptosis. The minimally invasive diagnostic represents the earliest detectable marker of insulin resistance and chronic diseases such as diabetes, developed in collaboration with leading academic researchers.
The breakthrough test provides unprecedented insight into pancreatic beta cell viability from a simple blood draw, opening an untapped $2 billion diagnostics market with virtually no direct competitors according to the company. The funding reflects strong investor confidence in Kihealth's approach to metabolic health and disease prevention, though the specific backers were not disclosed.
Clinical Applications Across Diabetes Spectrum
The diagnostic platform demonstrates significant utility across multiple diabetes care scenarios. In Type 1 diabetes prevention trials, Kihealth's biomarker enables stratification of high-risk individuals beyond traditional autoantibody screening and can distinguish between fast and slow disease progressors to achieve smarter enrollment. The test also serves as a pharmacodynamic endpoint for measuring early therapeutic response.
For Type 2 diabetes progression and obesity care, the assay can identify patients with rapid beta cell decline despite normal glucose levels. This capability allows clinicians to track beta cell viability during and post-treatment to optimize patient management, while supporting patient stratification to ensure trials have well-defined cohorts and more robust outcomes.
Market Impact and Recognition
The diagnostic test recently won the 2025 ADA Innovation of the Year Award, highlighting its potential clinical significance. Earlier and more accurate detection increases the pool of patients eligible for intervention while providing measurable biomarkers to track treatment impact and long-term outcomes.
"Our mission is to detect disease earlier and intervene smarter," said Jennifer Anderson, CEO and Co-Founder of Kihealth. "This new diagnostic test represents the future of preventive medicine: giving providers the power to act before overt disease takes hold, empowering patients with clarity, and enabling pharma to deliver more targeted, effective therapies."
Expanding Diagnostic Pipeline
Beyond diabetes, Kihealth is leveraging its proprietary platform to build a pipeline of minimally invasive diagnostics for early disease detection. The company has already developed diagnostics for gut health conditions and partnered with Genova Diagnostics to bring gut health testing directly to consumers via retail pharmacies in the United States.
The commercial rollout comes at a favorable regulatory moment for laboratory-developed tests, following the FDA's decision to rescind its Final Rule that would have classified LDTs as medical devices. The rule had drawn significant industry opposition for being viewed as impractical and disruptive to patient care needs in healthcare settings.
