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Cardio Diagnostics Prepares for New Test Launches Following IPO


NEW YORK – As Cardio Diagnostics goes public via a merger with a special purpose acquisition company this week, the Chicago-based firm is looking ahead to the launch of a heart disease test later this year to complement its current offering, as well as multiple product launches in 2023. 

The company, cofounded in 2017 by Meesha Dogan and Rob Philibert on the back of Dogan's doctoral research at the University of Iowa, uses epigenetics and DNA methylation markers in combination with machine learning tools to determine a patient's risk of cardiovascular disease. Its first product, Epi+Gen CHD, assesses someone's risk of developing coronary heart disease in the next three years and is currently offered by the company as a laboratory-developed test. 

Dogan, who is also the firm's CEO, said that the company's goal is to help guide the healthcare industry away from chronic disease management and more toward early detection and prevention to "redefine the standard of care" for heart disease. Because DNA methylation markers change over a patient's lifetime and are affected by environmental factors and lifestyle changes, looking at those markers in addition to other genetic markers allows for intervention before a patient has developed heart disease, she said. 

"If we're only looking at genetics, we're going to miss a lot of information … that otherwise would give us better visibility into who this person is and what their personal risk looks like," Dogan said. 

DNA methylation markers can change in as little as 90 days, she noted, so measuring those markers also allows a clinician to track the impact of a patient's behavioral changes over time. 

Using epigenetics for early detection has gained traction in the oncology field, but has seen less adoption outside of cancer, Dogan said. The firm saw cardiovascular disease as an area where it could "have a pretty large impact" on population health, particularly as the prevalence of heart disease in the US continues to grow, she said. 

The firm has an exclusive license to the technology developed by Dogan and Philibert at the University of Iowa and patented in the US and Europe by the university, which includes a machine learning algorithm that is able to look at three DNA methylation markers, as well as five other genetic markers, and detect patterns indicating a patient's risk of heart disease. The proprietary Integrated Genetic-Epigenetic Engine translates those patterns into a clinical test that uses a blood sample to determine whether a patient has low, borderline, intermediate, or high risk of developing coronary heart disease in the next three years. The risk categories are based on accepted clinical guidelines, and the test provides both the risk category and a percentage of risk that correlates to the category, Dogan said. 

The test also provides a peer group comparison based on age and sex as a way to understand how a patient fits in with the rest of the population. 

The assay is intended as a first line of prevention to be used in a primary care setting, and thus has relatively strict criteria for use, Dogan said. A patient must be at least 35 years old, show no signs of coronary heart disease, and have no diagnosis of coronary heart disease to be eligible for the test. 

The assay was validated in a study with Intermountain Healthcare published last year in Epigenomics that found the test was more sensitive than the Framingham Risk Score and ASCVD Pooled Cohort Equation (PCE), two risk assessment scores currently used for heart disease. Using data sets from the Framingham Heart Study and Intermountain, the test had a sensitivity of 79 percent and specificity of 75 percent with the FHS set and a sensitivity of 75 percent and specificity of 72 percent with the Intermountain set. In comparison, the Framingham Risk Score had a sensitivity of 15 percent and specificity of 93 percent, while the PCE had a sensitivity of 69 percent and specificity of 55 percent. 

Currently, the test is processed at Cardio Diagnostics' CLIA laboratory with a turnaround of about seven to 10 days, but as the company scales up and builds its capacity that turnaround time is expected to decrease to about 48 hours, Dogan said. The run time in the laboratory is only about four hours, and the report generation takes about an hour, she added. 

Gregory Burzynski, a physician who has used the test himself and is looking to implement it in his clinical practice, noted that heart disease can be complicated to diagnose and that the Epi+Gen CHD test could "provide a wake-up call" to patients who feel normal now. While he said the cost was a slight deterrent and would likely make it more of a premium test, rather than something done routinely, the opportunity for patients to get a baseline measure of their heart health could send the message that it's time to "do things differently." 

Although the $350 test currently isn't covered by any payors, it is eligible for health savings and flexible spending accounts, and Dogan said the firm is continuing to educate insurance companies, providers, and employers about the assay. 

The firm expects to scale up its operations as a result of its IPO this week. In May, the company announced that special purpose acquisition company Mana Capital Acquisition would merge with Cardio Diagnostics and be listed on the Nasdaq under the ticker symbol CDIO. According to Dogan, the firm "weighed the pros and cons" of going public and decided to take the plunge before Mana came into the picture. The benefits — namely, access to further capital, the ability to offer equity to attract new talent and potentially engage in M&A activity, and the likely increased transparency and recognition of being a public company — outweighed the difficulties of going public in a volatile market, she said.

The SPAC opportunity happened to come to Cardio Diagnostics once the decision to go public had been made and was a "vehicle" for the firm to achieve its goals, Dogan said. With the knowledge that it would be entering an unstable market with high inflation, the company raised enough money in a funding round with an undisclosed strategic investor to survive to the end of 2023, even without the money raised by the SPAC deal, she said. 

The company has its product pipeline for the rest of that time developed as well — by the end of this year, the firm plans to launch a test that determines a patient's current coronary heart disease status after they present with chest pain. Next year, two other tests will come onto the market: one for risk of stroke and one for risk of heart failure. The following year, Dogan said the firm plans to launch a test determining a patient's risk of developing diabetes, all using the same underlying technology. 

As of now, those tests are expected to be LDTs like the Epi+Gen CHD test, she said. However, the firm is working on a pre-submission to the US Food and Drug Administration for the CHD test and "continuing to evaluate" whether going through the FDA approval process is viable.