Kihealth has raised $5m in seed funding to support the commercial rollout of an early detection diagnostic test for diabetes and other metabolic health conditions that is claimed to be the first laboratory-developed test (LDT) of its kind.
While the US-based company said the seed round was oversubscribed, its backerswere not disclosed.
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For type 1 diabetes (T1D) prevention trials, Kihealth’s biomarker is designed to stratify high-risk individuals beyond traditional autoantibody screening and distinguish between fast and slow disease progressors to achieve smarter enrolment, according to the company.
The test also has application in type 2 diabetes (T2D) progression and evaluative obesity care, towards identifying patients with rapid beta cell decline despite normal glucose levels, tracking beta cell viability during and post-treatment to optimise patient management, and again stratifying patients to ensure that trials have well-defined cohorts.
Commenting on the financing, Kihealth’s CEO and co-founder Jennifer Anderson highlighted that company’s mission is to “detect disease earlier and intervene smarter”, and that enabling providers to act before a disease like diabetes takes hold, its new diagnostic test will provide patients with clarity while enabling pharma to deliver “more targeted, effective therapies”.
Using its proprietary assay platform, Kihealth has also developed diagnostics for the early detection-prevention of condition associated with gut health. With a patient’s gut health often evaluated in relation to conditions, including autoimmune diseases, mood disorders, and skin conditions, Kihealth partnered with Genova Diagnostics last year to bring gut health testing directly to consumers via retail pharmacies in the US.
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By GlobalDataLast month, clinical laboratories and other parties involved in the LDT space breathed a collective sigh of relief after the US Food and Drug Administration’s (FDA) announced it would effectively be rescinding its Final Rule that sought to classify LDTs as medical devices following its strike down in a Texas court earlier this year.
Issued in 2024, the Final Rule drew the ire of the industry, with many observers viewing the mooted legislation as impractical and disruptive towards meeting patient care needs in healthcare settings.
