MyOme Announces Launch of CAD iPRS and Beginning Enrollment in the COMPASS-CAD Prospective Trial

MyOme Launches Integrated Risk Tool for Coronary Artery Disease

MENLO PARK, Calif., Feb. 27, 2025 -- MyOme, Inc., a leading clinical whole genome testing and polygenic risk modelling (PRS) company, is proud to announce the launch of its coronary artery disease (CAD) PRS product – Integrated PRS, CAD (CAD iPRS). CAD iPRS integrates whole-genome sequencing data with clinical risk factors to provide a more accurate risk assessment for CAD compared to using traditional clinical factors alone. CAD iPRS is validated across multiple ancestries and provides a ten year absolute risk of developing CAD.

According to the American Heart Association (AHA), approximately 47% of adults are at risk for cardiovascular disease, including CAD⁽¹⁾. Approximately 375,000–representing 1 in 7–deaths occur annually in the United States as a result of CAD⁽²⁾, which is recognized as a significant public health issue by the AHA, CDC, and the National Institutes of Health.

The launch of CAD iPRS is supported by a validation study presented at the American College of Medical Genetics Annual Meeting, demonstrating that integrating a cross-ancestry polygenic risk score with traditional clinical factors significantly improves 10-year absolute risk prediction for CAD. The study validated the caPRS across multiple cohorts, including UK Biobank, MESA, Penn Medicine BioBank, and ARIC, showing its effectiveness across diverse ancestries. By combining genetics with the commonly used ASCVD Pooled Cohort Equation (PCE) into an integrated risk score (caIRS), the model improved risk discrimination and identified up to 27 additional CAD cases per 1,000 individuals in the borderline/intermediate PCE group. This enhanced stratification provides clinicians with a more precise tool to guide treatment decisions, particularly for patients with uncertain clinical risk.

"The launch of CAD iPRS supports our mission of leveraging the power of the genome to improve health outcomes for those at risk for the most deadly diseases," said Premal Shah, Ph.D., CEO of MyOme. "Physicians can now more accurately assess risk across their diverse patient population and develop a screening and treatment plan for even those cases that were traditionally challenging. In doing so, physicians can potentially help their patients eliminate or delay the onset of CAD."

CAD iPRS is now available as part of MyOme's broader suite of clinical offerings based on the genome or as an individual test. For more information, visit myome.com.

MyOme Partners with Penn Medicine on COMPASS-CAD Clinical Trial

The University of Pennsylvania (Penn), a world-renowned academic research and medical center with a history of innovation, was announced as the first site for the COMPASS-CAD trial, a prospective study that will provide participants with CAD iPRS to monitor clinical interventions and patient outcomes.

Enrollment in COMPASS-CAD (Clinical Outcomes Measured by Polygenic Assessment of Susceptibility Scores in Coronary Artery Disease) will be offered to patients who are part of the Penn Medicine BioBank (PMBB). The study will assess the real-world value of a risk predictor that combines genetic information and clinical risk information to identify individuals who may be missed or inaccurately assessed by traditional clinical risk assessments alone.

Participants, between ages 40-70 years, who have no history of CAD will be recruited from cohorts that have been previously genotyped and found to have borderline or intermediate CAD risk based on a CAD iPRS. Approximately 14,000 patients within the PMBB were deemed candidates for the trial based on the inclusion criteria. In total, 1,000 patients will be recruited for the trial across multiple sites.

"Current clinical methods fall short in providing an accurate risk assessment for Coronary Artery Disease," said Akash Kumar, M.D., Ph.D., MyOme's Chief Scientific and Medical Officer. "Models like PCE fail to integrate genetic factors and are often not calibrated across diverse ancestries. This trial will support inclusion of MyOme's CAD iPRS in routine clinical practice by observing how physicians and patients use a more holistic assessment of risk. We expect personalized screening and readily accessible interventions such as statins will improve compliance, lifestyle choices and ultimately improve outcomes."

Clinicians frequently encounter challenges when determining the best course of action for patients with borderline or intermediate risk, aware that current clinical tools and standards are not fully optimized for individuals of non-European or mixed ancestry.

"In my practice in the Philadelphia area, I see patients of diverse ancestries for whom current ASCVD tools do not assess risk equitably or adequately consider other genetic factors for CAD," said Penn Medicine cardiologist Daniel Rader, MD, the chief of the division of Translational Medicine and Human Genetics and chair of the department of Genetics at Penn's Perelman School of Medicine. "There are steps someone can take once we accurately identify those at risk, whether it is common medications such as statins, imaging or changes to lifestyle that can reduce heart-related events."

COMPASS-CAD started enrolling patients in November 2024 at Penn Medicine and has expanded to other sites. In COMPASS-CAD, patients classified as intermediate or borderline risk based on traditional clinical measurements will receive CAD iPRS; those reclassified as high-risk will be monitored for changes in clinical management and outcomes.

About MyOme's iPRS:

CAD iPRS is a genetics-informed risk assessment that integrates genetics from a whole-genome analysis with commonly collected clinical risk factors (e.g., LDL, blood pressure) and is validated across multiple ancestries⁽³⁾. Data indicates MyOme's cross-ancestry PRS approach (caPRS) shows improvement over several previously published models. Additionally, compared with the ASCVD PCE alone, the IRS has improved performance.⁽³⁾

About MyOme
MyOme is a clinical whole genome analysis platform company helping families understand their risk for inherited diseases. As a leader in polygenic risk modeling, MyOme leverages the power of the whole genome for a lifetime of meaningful and actionable insights. Certified under the Clinical Laboratory Improvement Amendments (CLIA) and certified by the College of American Pathologists (CAP), MyOme is based in Menlo Park, California. For more information, please visit myome.com.

About Coronary Artery Disease
Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.⁴ Heart disease cost the United States about $239.9 billion each year from 2018 to 2019.⁵ CAD is the most common type of heart disease, killing 375,476 people in 2021.⁶ The major blood vessels that supply the heart struggle to send enough blood, oxygen, and nutrients to the heart muscle. Cholesterol deposits in the heart arteries and inflammation are usually the cause of CAD. Signs and symptoms of CAD occur when the heart doesn't get enough oxygen-rich blood. If you have CAD, reduced blood flow to the heart can cause chest pain and shortness of breath. A complete blockage of blood flow can cause a heart attack. CAD often develops over decades. Symptoms may go unnoticed until a significant blockage causes problems or a heart attack occurs. Following a heart-healthy lifestyle can help prevent CAD.

References

1. American Heart Association (AHA)  Annual "Heart Disease and Stroke Statistics Update"
2. Centers for Disease Control (CDC) Heart Disease Facts
3. Tshiaba, Placede, et al. "P333: Polygenic risk scores improve 10-year risk prediction of coronary artery disease in individuals at borderline and intermediate clinical risk." Genetics in Medicine Open 1.1 (2023): 100361.
4. National Center for Health Statistics. Multiple Cause of Death 2018–2021 on CDC WONDER Database. Accessed February 2, 2023.
5. National Center for Health Statistics. Percentage of coronary heart disease for adults aged 18 and over, United States, 2019—2021. National Health Interview Survey. Accessed February 17, 2023.
6. Tsao CW, et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association, Circulation. 2023;147:e93–e621.

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