New Prevencio Study Using AI Demonstrates Novel Blood Test Accurately Predicts Acute Kidney Injury (AKI) Risk

In this study, researchers evaluated the company’s AI-driven HART AKI test on 889 patients undergoing cardiac catheterization in Massachusetts General Hospital’s (MGH) Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA) study. The HART AKI test algorithmically interprets six clinical and protein variables (history of diabetes, blood urea nitrogen to creatinine ratio, C-reactive protein, osteopontin, CD5 antigen-like, and Factor VII). The HART AKI had an impressive negative predictive value of 98% and an overall accuracy measurement of 82% (AUC=0.82).

Principal investigator James L. Januzzi, MD, practicing cardiologist at MGH and Professor of Medicine at Harvard Medical School, said, “AKI following coronary angiographic procedures is associated with significant morbidity and death. A test that accurately predicts risk for AKI is of great value, as it can alter patient management; this might include minimizing dye exposure and increasing pre-procedure hydration. In patients with diabetes or heart failure, where risk for Chronic Kidney Disease (CKD) is higher, a high HART AKI score may lead to delaying elective angiography plans until such comorbidities are better managed. Additionally, 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.”

Cardiac catheterization (also called cardiac cath or coronary angiogram) is an invasive imaging procedure that allows your doctor to evaluate blood flow to your heart. During cardiac catheterization, a thin tube, called a catheter, is inserted in an artery or vein, usually in your groin area, and is threaded through your blood vessels to your heart. Contrast dye is injected for imaging and is the primary cause of AKI.

The number of cardiac catheterization or percutaneous coronary intervention (PCI) cases resulting in AKI rose almost 3‐fold from 2001 to 2011. Prediction and prevention strategies, such as the HART AKI test, are needed to reverse this alarming rise in AKI.

“This AHA presentation adds to the growing volume of presented and published peer-reviewed, scientific literature supporting the accuracy and clinical benefit of our novel AI-driven HART tests,” said Rhonda Rhyne, Prevencio’s Chief Executive Officer. “We have had an unprecedented ten presentations and publications over the past two years. The potential of our HART tests to fulfill the urgent need for alternative, reliable, and cost-effective cardiovascular diagnostic and monitoring solutions is encouraging.”

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 and continued dedication in developing and validating Prevencio’s novel HART tests. With our ongoing positive HART test results, we are fulfilling our mission of revolutionizing blood tests for cardiovascular disease—powered by AI.”

About Prevencio HART Tests:

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

These tests are:

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

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

HART test results have also been published in top-tier cardiology journals (Journal of American College of Cardiology – March 2017, American Journal of Cardiology – July 2017, and Clinical Cardiology – June 2018).

About Prevencio, Inc.:

Prevencio’s value proposition is “Preventing the Preventable — That is, preventing unnecessary procedures and related side effects, as well as improving patient outcomes and clinical trials through more accurate blood tests for Cardiovascular Disease conditions. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver cardiovascular diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, individual biomarkers, genetic markers and clinical risk scores. The company is headquartered in Kirkland, Washington. For additional information, visit www.PrevencioMed.com. Prevencio—Preventing the Preventable.™

About American Heart Association (AHA) Scientific Sessions:

AHA’s Scientific Sessions attracts nearly 18,000 attendees, with a global presence from more than 100 countries. In addition, two million medical professionals participate virtually in lectures and discussions about basic, translational, clinical and population science.

Forward-Looking (Safe Harbor) Statement:

Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need and size, the accuracy of which is necessarily subject to uncertainties and risks including the Company’s sole dependence on HART technology and various uncertainties characteristic of development-stage companies. The Company does not undertake to update the disclosures contained in this press release.