Cardio Diagnostics, a University of Iowa faculty startup, has commercially launched a new home clinical test for assessing patients’ heart disease risk.

The product, the Epi+Gen CHD at-home sampling kit, was made possible through a license held by the UI Research Foundation.

Heart disease and stroke are the first and fifth leading causes of death in the United States, respectively and are responsible for one in every four deaths. It’s estimated that more than 80 percent of cardiovascular disease can be prevented by early medication and lifestyle interventions.

To receive the test, potential patients fill out a screening questionnaire that is reviewed by a board-certified clinician. If eligible, a sampling kit is mailed to the patient’s home. After the sample is collected, it’s shipped using an enclosed prepaid mailer to Cardio Diagnostics’ partner Clinical Laboratory Improvement Amendments (CLIA)-certified lab for processing followed by clinical report generation by Cardio Diagnostics. After review and approval by a board-certified pathologist, the results are released to the ordering clinician for review and discussion with the patient.

Epi+Gen CHD is intended as an alternative to the two main tools available to clinicians for predicting risk for heart disease: the Framingham Risk Score (FRS) and the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator.

Robert Philibert MD Ph.D., co-founder and chief medical officer of Cardio Diagnostics and professor of psychiatry in the UI Carver College of Medicine, said Epi+Gen CHD not only predicts who is at lower risk of developing coronary heart disease, which current tests do well, but also identifies who is at higher risk of developing coronary heart disease, which current tests do not do well.

Cardio Diagnostics’ Chief Executive Officer and Co-Founder Meeshanthini (Meesha) Dogan Ph.D., said the kit is based on the latest research in epigenetics (the study of heritable changes in gene expression) and artificial intelligence/machine learning. She added that home tests like Epi+Gen CHD are especially helpful at keeping patients safe from exposure during the COVID-19 pandemic.

Last summer, Cardio Diagnostics was recognized as a “one to watch” as part of the inaugural Spinoff Prize, organized by Nature Research and Merck KGaA. The prize showcases and celebrates global excellence in the commercialization of research through the creation of spinoff companies.

Founded in 2017 and headquartered in the UI Research Park in Coralville, Cardio Diagnostics Inc. focuses on human health by developing and commercializing patent-pending, precision medicine tools for the prevention of heart disease and stroke. The company harnesses artificial intelligence and DNA-based biosignatures to assess risk, personalize management, and monitor response for cardiovascular disease.

The UI Research Foundation is part of the University of Iowa Office of the Vice President for Research, which provides researchers and scholars with resources, guidance, and inspiration to secure funding, collaborate, innovate, and forge frontiers of discovery that benefit everyone. More at http://research.uiowa.edu, and on Twitter: @DaretoDiscover.