Development of a cell-free RNA diagnostic test for kawasaki disease

The National Heart, Lung, and Blood Institute awarded Romix Biosciences Inc. $1,343,973 on August 10, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to develop a cell-free RNA diagnostic test for Kawasaki Disease.

Romix will develop and validate a diagnostic assay using plasma cell-free RNA signatures to identify Kawasaki Disease and differentiate it from other pediatric febrile illnesses. The work encompasses automating and streamlining sample processing, conducting large-scale biomarker discovery using pre-treatment plasma samples from Kawasaki Disease patients and febrile controls, translating identified signatures to the Thermo Fisher TaqMan Array Card platform for quantitative PCR testing, and validating the assay's performance using prospectively collected clinical samples. This diagnostic approach aims to replace current clinical diagnosis with a definitive molecular diagnosis executable through routine blood draw and standard PCR equipment, enabling faster diagnosis and reducing the risk of coronary heart disease complications in affected children.

The award is a Phase II Small Business Innovation Research grant. Performance occurs in Ithaca, New York, with the period of performance running through July 31, 2028. The project builds on established collaborations with UCSD/Rady's Children's Hospital, Children's Healthcare of Atlanta, Children's National Hospital, Boston Children's Hospital, and Children's Hospital Colorado.

Abstract

Kawasaki disease (KD) is a systemic vasculitis of unknown etiology and the leading cause of acquired heart disease in children. Timely treatment with intravenous immunoglobulin (ivig) can reduce the risk of heart disease from 25% to 3%. Unfortunately, many patients are treated too late because there is no diagnostic test for KD and the clinical signs of KD are overlapping with many other febrile illnesses in childhood. Furthermore, ivig cannot be administered broadly because IT is an expensive human blood product. In this proposal, we will develop the first diagnostic test for KD using plasma cell-free RNA (cfrna) signatures and translate these signatures to a PCR platform, enabling faster diagnosis and improving outcomes. The proposed technology will turn what is currently a clinical diagnosis into a definitive molecular diagnosis that can be quickly tested for with a routine blood draw and nearly ubiquitous PCR equipment. This proposal builds upon established collaborations among the teams at romix biosciences, ucsd/rady's children's hospital, children's healthcare of atlanta, children's national hospital, boston children's hospital, and children's hospital colorado. First, we will automate and streamline sample processing which will enable romix to quickly process the requisite volume of samples included in this study as well as expand to other indications in the future. Next, we will use the automated sample processing platform to perform large-scale biomarker discovery using pre-treatment plasma samples from KD patients and highly relevant febrile controls, delineating KD from other pediatric febrile illnesses. These signatures will then be translated to the thermo fisher taqman array card platform to measure the utility of a cfrna-based qpcr test for diagnosing KD. Finally, we will validate the performance of this assay using clinically relevant patient samples prospectively collected from across the united states. The work proposed here will culminate in a diagnostic PCR panel for KD, the clinical data to engage with in vitro diagnostic platform developers to license the panel, and an automated sample processing workflow that is ready for regulatory review as a laboratory developed test. Lastly, this proposal will establish romix biosciences as a leader in cfrna diagnostics and create a platform for expansion to other disease indications.