MyOme Launches CAD iPRS, Opens COMPASS-CAD Trial

MyOme Launches CAD iPRS, Opens COMPASS-CAD Trial

February 27, 2025 Catherine Williams Health

MyOme Launches Integrated Risk Tool for Coronary Artery Disease

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MENLO PARK, Calif., Feb. 27, 2025 — MyOme, Inc., a leading clinical whole genome testing and polygenic risk modeling (PRS) company, is proud to announce the launch of its coronary artery disease (CAD) PRS product – Integrated PRS for CAD (CAD iPRS). The innovative tool 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. Validated across multiple ancestries, CAD iPRS offers a ten-year absolute risk prediction for developing CAD, aiding healthcare providers in making evidence-based decisions in a precision medicine era.

According to statistics from the American Heart Association (AHA), approximately 47% of adults in the United States are at risk for some form of cardiovascular disease, including coronary artery disease. An estimated 375,000 Americans, representing 1 in 7 deaths, succumb annually to CAD, which is recognized as a significant public health issue by the American Heart Association, the CDC, and the National Institutes of Health.

Jordon’s personal anecdote with her diabetic patient, where she has been successfully treated and has regained her health speaks volumes about how screening risk assessment, especially genetic screening can lead to better treatment and screening can lead ultimately to eliminating or delaying the onset of CAD in patients.

MyOme, with its integrated PRS for CAD, provides clinicians an additional tool in the armamentarium of prevention and treatment of CAD, especially for challenging cases, where age, sex, blood pressure, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, diabetes, smoking, and family history might be the factors affecting or guiding the treatment options.

The launch of CAD iPRS is supported by a validation study presented at the American College of Medical Genetics Annual Meeting. The study showed that integrating a cross-ancestry polygenic risk score with traditional clinical factors significantly improves 10-year absolute risk prediction for CAD. The study was validated across multiple cohorts, including UK Biobank, MESA, Penn Medicine BioBank, and ARIC, demonstrating its effectiveness across diverse ancestries. By combining genetic information with the commonly used ASCVD Pooled Cohort Equation (PCE) that integrates age, sex, total cholesterol, high-density lipoprotein (HDL) cholesterol, treated or untreated systolic blood pressure, diabetes, and smoking, MyOme’s integrated risk score (caIRS or CAD IRS) significantly improves risk discrimination. The model 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 genome testing or as an individual test. It has been certified under the Clinical Laboratory Improvement Amendments (CLIA) and by the College of American Pathologists (CAP). For more information, visit MyOme’s website.

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. This study will provide participants with CAD iPRS to monitor clinical interventions and patient outcomes.

Enrollment in COMPASS-CAD is 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 40-70 years old without a history of CAD and previously found to have borderline or intermediate CAD risk based on CAD iPRS, within cohorts that have been genotyped, will be recruited for the trial. Out of approximately 14,000 patients, at Inverarity’s Lab within the PMBB, 1,000 are planned for recruitment for the trial across multiple sites.

“Current clinical methods fall short in providing an accurate risk assessment for Coronary Artery Disease,” said MyOme’s Akash Kumar, a Ph.D. and 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,” adds Dr. Rader, “whether it is common medications such as statins, imaging, or changes to lifestyle, that can reduce heart-related events.

The COMPASS-CAD trial began enrolling patients in November 2024 at Penn Medicine and has expanded to other recruitment 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, such as LDL, blood pressure, and validated across multiple ancestries. Data indicates MyOme’s cross-ancestry PRS approach (caPRS) shows improvement over several previously published models. Additionally, compared to the ASCVD PCE alone, the IRS has improved performance.

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. Based in Menlo Park, California, MyOme is certified under the Clinical Laboratory Improvement Amendments (CLIA) and by the College of American Pathologists (CAP). MyOme is revolutionizing preventive medicine.

About Coronary Artery Disease

Over 1 in 4 deaths in the United States is due to heart-related issues, and coronary heart disease was the leading cause of death for each year 2019, 2020, and 2021. The cost of coronary heart disease was about 239.9 billion from 2018 to 2019. Known mostly as the main type of heart disease affecting Americans, Coronary Artery Disease, commonly referred to as CAD, kills about 375,476 individuals in a single calendar year. While the major blood vessels usually supply adequate blood and nutrients to the heart, cholesterol deposits and inflammation of these blood vessels abruptly hinders the flow of these blood vessels, triggering blood vessel obstruction. All this usually culminates in discomforts and shortness of breath in people with coronary artery disease. A coronary artery blockage may cause a heart attack and could be fatal.

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.
  5. National Center for Health Statistics. Percentage of coronary heart disease for adults aged 18 and over
  6. Tsao CW, et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation. 2023;147:e93–e621.

Courtesy Penn Medicine and MyOme.

MyOme Launches Integrated Risk Tool for Coronary Artery Disease

What is CAD iPRS and how does it improve risk assessment for coronary artery disease?

Answer:

CAD iPRS, or Integrated PRS for CAD, is a groundbreaking tool launched by myome, Inc. that combines whole-genome sequencing data with customary clinical risk factors to provide a more accurate risk assessment for coronary artery disease (CAD). Developed to enhance precision medicine, CAD iPRS predicts a patient’s ten-year absolute risk of developing CAD. it has been validated across multiple ancestries, improving risk stratification compared to traditional risk assessments.This tool supports physicians in making evidence-based decisions and offers a more refined risk assessment than conventional methods alone [supporting data from the American college of Medical Genetics Annual Meeting][1].

Why is CAD a meaningful public health issue in the United States?

Answer:

Coronary artery disease (CAD) is the most prevalent type of heart disease in the U.S. and is responsible for approximately 375,000 deaths per year, representing 1 in 7 deaths. According to the American Heart Association (AHA), about 47% of adults in the United States are at risk for some form of cardiovascular disease, including CAD. This prevalence underscores the critical public health challenge posed by CAD, recognized by the AHA, CDC, and National institutes of Health as a severe health issue [statistics & citations from authoritative sources][2].

how is CAD iPRS validated, and why is it more effective across diverse populations?

Answer:

CAD iPRS underwent rigorous validation in a study presented at the American College of Medical Genetics Annual Meeting, demonstrating its efficacy in improving 10-year absolute risk predictions for CAD. The validation was performed across diverse cohorts, including UK Biobank, MESA, Penn Medicine BioBank, and ARIC, showcasing the tool’s effectiveness across different ancestries. By integrating genomic data with clinical risk factors used in the ASCVD Pooled Cohort Equation (PCE), MyOme’s tool, also known as caIRS or CAD IRS, considerably enhances risk discrimination. it identifies up to 27 additional CAD cases per 1,000 individuals with borderline or intermediate risk, providing a holistic risk assessment [supporting study][1].

What role does MyOme play in preventive medicine with CAD iPRS?

Answer:

MyOme plays a transformative role in preventive medicine by offering CAD iPRS as part of their suite of clinical offerings. This genetics-informed risk assessment tool is available both individually and as part of their whole genome testing suite. CAD iPRS, certified under CLIA and CAP, aids healthcare providers in early screening and precision interventions for CAD, possibly delaying or preventing the onset of the disease. MyOme aims to revolutionize preventive medicine by leveraging whole-genome analysis and polygenic risk scoring [authenticated by MyOme’s certification and clinical alliances][3].

How does the COMPASS-CAD clinical trial contribute to CAD patient outcomes?

Answer:

Launched in partnership with Penn Medicine, the COMPASS-CAD clinical trial aims to evaluate the effectiveness of CAD iPRS in real-world settings. Patients aged 40-70 with no CAD history and identified as moderate risk through CAD iPRS will be monitored to assess the clinical interventions’ impact on lowering patient risk. The trial addresses gaps in current risk assessments by considering genetic and clinical factors, aiming to refine patient management strategies. Personalized interventions, such as medication and lifestyle changes, are expected to improve patient outcomes based on risk assessment using CAD iPRS [study initiation and details from Penn Medicine][4].

Why is genetic screening crucial for managing conditions like coronary artery disease?

Answer:

Genetic screening through tools like CAD iPRS is crucial as it offers a extensive risk assessment by combining genetic information with traditional risk factors. Genetic predispositions can significantly affect the accuracy of CAD risk predictions, especially in non-European or mixed ancestry groups where traditional tools may falter. By integrating genetic data, MyOme’s CAD iPRS supports more equitable risk assessments, leading to tailored preventive strategies, accurate screening, and more timely interventions. This enhances patient care by potentially reducing the occurrence of heart-related events [validation across multiple ancestries and expert opinions][5].

How does CAD iPRS integrate with existing clinical practices?

Answer:

CAD iPRS integrates seamlessly with existing clinical practices by supplementing traditional clinical risk assessments, such as the ASCVD Pooled Cohort Equation (PCE), with genetic insights. Clinicians can use this integrated approach to refine treatment plans for patients at varying risk levels, especially those with borderline or intermediate risk according to PCE. By identifying additional at-risk individuals, CAD iPRS ensures that patients receive appropriate follow-up, potentially reducing the incidence of adverse cardiac events. This integration facilitates holistic patient care and better risk management [endorsements from MyOme and clinical validations][3].

References

  1. [Future Reports – MyOme Coronary Artery Disease (CAD) Integrated Risk with Polygenic Risk Score (PRS) Report][1]
  2. [American Heart Association (AHA) Annual “Heart Disease and Stroke Statistics Update”][2]
  3. [Report on significant betterment in risk prediction using cross-ancestry polygenic risk scores][4]
  4. [Further details and study outcomes from the COMPASS-CAD trial][5]

For further insights and information, visit MyOme’s official website or the reputable resources linked above.

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About MyOme and MyOme’s iPRS

MyOme is a leader in clinical whole-genome analysis and polygenic risk modeling. Headquartered in Menlo Park, California, MyOme’s Integrated PRS for CAD (iPRS) expands upon conventional CAD risk assessments by integrating genetic data. Consequently, their CAD iPRS tool has shown improved performance in identifying coronary artery disease across multiple ancestries, marking a significant advancement in preventive healthcare strategies.