Prevencio, Inc. today announces data demonstrating its HART PAD™ blood test accurately diagnoses peripheral artery disease (PAD) in diabetes mellitus (DM) patients, a patient population in which PAD prevalence has traditionally been difficult to assess.

Researchers believe these important findings, presented August 25 at the 2018 European Society of Cardiology (ESC) Congress in Munich, Germany, could lead to early identification of PAD and improve patient clinical outcomes, as well as prevent patients without PAD from undergoing unnecessary, expensive, and invasive tests.

The study is follow-on to data presented at the American Diabetes Association (ADA) 2018 Scientific Sessions in June 2018 demonstrating Prevencio’s HART CAD™ and HART CVE™ tests accurately diagnose coronary artery disease (CAD) and predict the risk for major adverse cardiac events (MACE) in DM patients. Similar to CAD, PAD is commonly due to atherosclerosis, a plaque buildup in the arteries which restricts blood flow.

In this study, researchers assessed the company’s AI-driven HART PAD diagnostic test on patients enrolled in Massachusetts General Hospital’s (MGH) Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA) study. The HART PAD test algorithmically assesses six biomarkers linked to atherosclerosis, as well as a patient’s history of hypertension. In patients with DM, the HART PAD panel had excellent performance for diagnosis of PAD. Using a 5-point score, a score of 1 had a 100% Negative Predictive Value (NPV) and a score of 5 had a 95% Positive Predictive Value (PPV). Additionally, the HART PAD panel was highly accurate in predicting the need for revascularization in patients with PAD. These results were comparable to those patients without DM.

Principal investigator James L. Januzzi, MD, practicing cardiologist at MGH and Professor of Medicine at Harvard Medical School, said, “The HART PAD test may allow for the diagnosis and treatment of many more patients with currently undetected PAD. In the clinical setting, these findings could assist physicians to identify peripheral artery disease earlier, provide guideline-recommended care, and monitor at-risk patients for vascular complications. We believe HART tests could also play an important role in identifying high risk patients for enrollment in clinical trials, thereby saving time and lowering overall trial costs.”

PAD affects more than 202 million people worldwide and is often underdiagnosed and undertreated until the disease has reached advanced stages. Patients with DM are at substantial risk of developing PAD. Patients with PAD have increased risk of CAD, heart attack, or stroke, and, if left untreated, PAD can lead to foot or leg amputation. Prevencio has also developed the HART AMP™ to accurately predict a patient’s risk for amputation.

According to the Centers for Disease Control and Prevention, more than 30 million Americans have diabetes and the total direct and indirect costs associated with patients diagnosed with diabetes total $327 billion annually.

“This ESC presentation adds to the growing volume of presented and published scientific literature supporting the accuracy and clinical benefit of our novel HART tests,” said Rhonda Rhyne, Prevencio’s Chief Executive Officer. “The potential of our HART tests to fulfill the urgent need for alternative, reliable, and cost-effective cardiovascular diagnostic and monitoring solutions is encouraging, especially for diabetic patients. For this underserved patient population, PAD and CAD can result in significant morbidity and mortality due to lack of diagnosis and timely treatment.”

Rhyne added, “On behalf of the Prevencio team, I would like to extend sincere gratitude to Massachusetts General Hospital, Dr. Januzzi and his researchers, and Myriad RBM for their significant contributions to date and their continued dedication in developing and validating Prevencio’s novel HART tests.”

About Prevencio HART Tests:
Powered by AI, Prevencio is revolutionizing blood tests for cardiovascular disease. Employing this novel approach, the company has produced five blood tests to date that significantly improve diagnoses for a variety of heart and blood vessel-related complications.

These tests are:

  1. HART CAD™ – obstructive coronary artery disease diagnosis
  2. HART CVE– 1-year risk of heart attack, stroke or cardiac death
  3. HART PAD™ – peripheral artery disease diagnosis
  4. HART AS™ – aortic valve stenosis diagnosis
  5. HART AMP™ – risk of amputation

HART test results have been presented at leading cardiovascular meetings – (European Society of Cardiology Congress Scientific Sessions – 2016, American College of Cardiology Scientific Sessions – 2017, American Heart Association Scientific Sessions – 2017, American College of Cardiology Scientific Sessions – 2018, American Diabetes Association Scientific Sessions – 2018, and European Society of Cardiology Congress Scientific Sessions – 2018).

HART test results have also been published in top-tier cardiology journals (Journal of American College of CardiologyMarch 2017, American Journal of CardiologyJuly 2017, and Clinical CardiologyJune 2018).