Cardio Diagnostics Holdings (NASDAQ: CDIO) has launched a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in Iowa City, Iowa, marking a shift from third-party sample processing to in-house operations.
The facility, which received full certification following an inspection with no deficiencies, now handles clinical sample processing for the company’s multi-omics cardiac tests, including Epi+Gen CHD and PrecisionCHD. Cardio Diagnostics has secured out-of-state licenses in California, Maryland, Rhode Island, and Pennsylvania, with a New York license pending approval.
The in-house model replaces per-test outsourcing costs and is expected to support gross margins of approximately 40% at scale, according to company projections. Current turnaround time for test results ranges from 7 to 10 business days from sample receipt. The Iowa City facility also includes a research laboratory dedicated to epigenetic methods, quality control, and precision measurement tools for detecting changes in epigenetic biomarkers over time.
The move follows data from AMN Healthcare’s 2025 Survey of Physician Appointment Wait Times, which reported an average wait time of 32.7 days for new cardiology appointments and 23.5 days for family medicine appointments across 15 major metropolitan areas.
Cardio Diagnostics CEO and Co-Founder Meesha Dogan stated, “Bringing our laboratory operations in-house is a defining step for Cardio Diagnostics. Owning the entire process, from the moment a sample arrives to the moment a provider receives a result for their patient, lets us strengthen quality control, streamline turnaround time, and deliver a more consistent experience while continuing to increase our test margin.”
