Noridian latest MAC to make Elucid PlaqueIQ™ image analysis software available for eligible patients

BOSTON: #AI--Elucid has announced that Noridian will extend coverage for AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ™ image analysis software, beginning December 8, 2024. With this decision, five of the seven Medicare Administrative Contractors (MACs) will soon provide coverage for AI-enabled quantitative coronary plaque analysis, expanding accessibility to over 70 percent of eligible Medicare patients across the United States.

The updated policy will allow for Medicare patients whose claims are administered within the five MACs who present with acute or stable chest pain and no known history of cardiovascular disease to be assessed with AI-enabled plaque imaging software. Elucid’s PlaqueIQ was designed to help physicians accurately diagnose and potentially personalize treatment for cardiovascular disease.

“AI-enabled plaque software allows, for the first time, accurate quantitation of atherosclerosis, allowing clinicians to scale their treatments based upon plaque burden and types of plaque, moving firmly into the realm of personalized medicine,” said Matthew Jay Budoff, MD, FACC, FAHA, professor of medicine at UCLA’s David Geffen School of Medicine, and the Endowed Chair of Preventive Cardiology at Harbor-UCLA Medical Center. “This has great implications for patient care and improved outcomes, being able to match intensity of treatment with level of risk.”

Cardiovascular disease (CVD) is the most common cause of death and disability globally, largely driven by myocardial infarction (MI) and ischemic stroke caused by atherosclerosis (plaque build-up and rupture in the arteries).1 The cost of CVD in the U.S. alone is approximately $219 billion per year, which includes the cost of healthcare services, medications and premature death.2 Moreover, the total cost of CVD is estimated to more than triple for people over 80 and more than double for people ages 65 to 79 by 2035.3

Elucid’s PlaqueIQ is the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques. PlaqueIQ is designed to give physicians new, clinically validated information to help stratify patients and inform patient-specific treatment pathways.

“This latest expansion of coverage by Noridian means that even more patients could be positively impacted by PlaqueIQ, which offers the only non-invasive measurement of lipid-rich necrotic core, a vulnerable, high-risk component of plaque that can lead to heart attack and stroke,”4 said Kelly Huang, CEO of Elucid. “These recent decisions from five of the seven MACs recognize the importance of new technologies like ours that can help quantify and classify coronary artery plaque to help physicians reduce the clinical and economic burden of cardiovascular disease.”

PlaqueIQ utilizes first-line diagnostic CCTA and develops comprehensive, interactive reports to help physicians virtually “see” and quantify plaque. With its basis in histology, the software is uniquely able to non-invasively quantify and characterize plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques that are key drivers of risk of heart attack and stroke. In addition, use of the software has the potential to enable earlier identification of higher-risk plaque before presence of symptoms or major adverse events.

About Elucid

Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQ™ product is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease. PlaqueIQ is the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit elucid.com.

References:

1 World Health Organization (WHO), Cardiovascular diseases (CVDs). 2017 23, April 2020. Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
2 Centers for Disease Control and Prevention, Office of Policy, Performance, and Evaluation, Health Topics - Heart Disease and Heart Attacks. August 17, 2021. Available from: https://www.cdc.gov/policy/polaris/healthtopics/heartdisease/index.html.
3 American Heart Association. Cardiovascular Disease: A Costly Burden for America - Projections Through 2035. 2017. Available from: https://www.heart.org/-/media/Files/About-Us/Policy-Research/Fact-Sheets/Public-Health-Advocacy-and-Research/CVD-A-Costly-Burden-for-America-Projections-Through-2035.pdf.
4 Martinet, W., Coornaert, I., et. al. Regulated Necrosis in Atherosclerosis. Arteriosclerosis, Thrombosis, and Vascular Biology. 2022;42(10):1283-1306.

Fonte: Business Wire