The new in-house laboratory facility will give Cardio Diagnostics end-to-end ownership of test processing and expand research capabilities for ongoing and future studies in precision monitoring of cardiovascular health.

Cardio Diagnostics Holdings, Inc. (NASDAQ:CDIO), an AI-driven precision cardiovascular medicine company, today announced the official launch of its in-house, high complexity CLIA-certified laboratory in Iowa City, Iowa. The new facility gives Cardio Diagnostics end-to-end control over the processing of its multi-omics clinical tests, Epi+Gen CHD™ and PrecisionCHD™, from sample receipt to result delivery, replacing the third-party arrangement previously used for clinical sample processing.

Within a year, the facility was staffed, equipped, and established to specification, culminating in the laboratory receiving its federal Clinical Laboratory Improvement Amendments (CLIA) license after undergoing an inspection by a CLIA compliance manager that found no deficiencies. Cardio Diagnostics has also secured out-of-state licenses from California, Maryland, Rhode Island, and Pennsylvania, and is actively pursuing securing its final license from the state of New York, which has distinct requirements.

"Bringing our laboratory operations in-house is a defining step for Cardio Diagnostics," said Meesha Dogan, Ph.D., CEO and Co-Founder of 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."

Cost structure and margin

Processing these samples in-house has several key advantages. This includes trading the highly variable per-test outsourcing cost for a more controllable cost structure, improving the unit economics and margin as sample volume grows. The company expects this model to support gross margins of approximately 40% at scale.

Turnaround time

In-house processing also gives Cardio Diagnostics direct control over quality control procedures and more critically, helps control turnaround time of patient results. Cardio Diagnostics’ current turnaround time is 7 to 10 business days from sample receipt at the lab, which is a meaningful advantage in a healthcare system where the appointment itself is often the longest part of the wait. The company expects that owning the workflow will allow it to tighten that window over time.

Turnaround matters: according to AMN Healthcare’s 2025 Survey of Physician Appointment Wait Times, across the 15 major metropolitan areas surveyed patients wait an average of 32.7 days for a new cardiology appointment and 23.5 days for a family medicine appointment. This doesn’t take into account subsequent follow-up care to run additional diagnostics or review test results, which further exacerbates wait times for patients.

A faster, more predictable test turnaround time, especially when combined with virtual telemedicine visits supported by Cardio Diagnostics’ testing process, gives providers actionable results sooner, without prolonging the patient’s care journey.

Research and precision monitoring

The Iowa City facility also houses a research lab to strengthen the company’s pioneering research in the role of precision epigenetic methods to support more targeted cardiovascular care.

The facility will help advance a broader company initiative to build a high-precision monitoring system for cardiovascular health. Vertical integration allows Cardio Diagnostics to develop its own quality control and precision measurement tools, supporting more accurate detection and quantification of changes in epigenetic biomarkers over time and enabling those changes to be linked to therapeutics.

Together, these capabilities aim to improve patient care, support more predictable costs, and strengthen quality and consistency for the providers, employers, brokers, and patients who have incorporated Cardio Diagnostics’ multi-omics tests into their cardiovascular care and risk management strategy.

About Cardio Diagnostics

Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine ("Core Technology") for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit https://cdio.ai/

Forward-Looking Statements

Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases "will", "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," "goal," or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on results are discussed in the Current Report on Form 10-K for the period ended in December 31, 2025, under the heading "Risk Factors" in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company’s financial performance and could cause the Company’s actual results for future periods to differ materially from any opinions or statements expressed within this press release.

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