Prevencio's Hart PAD Blood Test Evaluated for Diagnosis PAD in Patients With Diabetes
August 29, 2018—Prevencio, Inc. announced data were presented demonstrating that the company's Hart PAD test accurately diagnoses peripheral artery disease (PAD) in patients with diabetes mellitus (DM). The multiprotein, artificial intelligence-driven Hart PAD test algorithmically assesses six biomarkers linked to atherosclerosis, as well as a patient's history of hypertension. The data were presented at the European Society of Cardiology Congress 2018 held August 25–29 in Munich, Germany.
According to the company, PAD prevalence has been difficult to assess in patients with DM. The study investigators believe these findings 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.
Investigators assessed the Hart PAD diagnostic test on patients enrolled in Massachusetts General Hospital's CASABLANCA study.
The company reported that in patients with DM, the Hart PAD panel had excellent performance for diagnosis of PAD. Using a five-point score, a score of 1 had a 100% negative predictive value and a score of 5 had a 95% positive predictive value. 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, advised Prevencio.
The study's principal investigator James L. Januzzi, MD, commented in Prevencio's announcement, "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 PAD 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."