Whole-body MRI maker Prenuvo has announced the launch of an unprecedented, large scale, prospective clinical research study, Project Hercules, which aims to assess the accuracy of whole-body MRI (WB-MRI) screening in predicting clinically significant diagnoses in the general population. Image courtesy: Prenuvo.
June 27, 2024 — Prenuvo, which makes whole-body MRI screening for early cancer detection and other diseases, has announced the launch of its first clinical research study at the Hercules Research Center outside Boston, MA. The study, Project Hercules, aims to demonstrate how Prenuvo’s whole-body MRI (WB-MRI) screening method can predict clinically significant diagnoses in the general population as well as identify new biomarkers of disease, according to a written statement released by the company.
Only 14 percent of diagnosed cancers are found through a recommended gold standard screening test. As a result, most cancers are typically detected when symptoms have already appeared. The company further explained that this status quo of reactive healthcare often results in cancers being found at a later stage, making them more difficult and expensive to treat. This, it notes, is why Prenuvo is sponsoring the Hercules Research Center, a research facility focused on whole-body MRI scans, to spearhead a paradigm shift from reactive to proactive healthcare. Over a 10-year period, the Hercules Project clinical research study will gather screening data to assess diagnostic and clinical outcomes.
Focusing on Heath Equity
Recognizing both the social need and the scientific need to address healthcare disparities that may relate to social inequities, the initial health-equity criterion established by the clinical research study will be being a SNAP participant, which will qualify the individual for complete subsidization of their participation. The goal of the clinical research study is to enroll at least 10% and up to 50% of participants who meet a health equity qualification, subsidizing between 50-100% of participation costs for those individual participants.
Many demographics have historically been under-represented in clinical research, a reality that has been reported to threaten the overarching goals of clinical research for a multitude of reasons. To address this disparity, the Hercules clinical research study will enroll 100,000 male and female participants aged 18 and older, emphasizing health-equity concerns to assist enrollment of individuals from groups that are historically medically under-served and under-represented in clinical research, including BIPOC (Black, Indigenous, and People of Color) individuals, and track them over multiple years of screening.
Addressing Unmet Needs with Early Detection
"There is an unmet health-system need to enable, detection of early-stage disease processes before they become irreversible chronic or progressive clinical disease-states, when gentler, less invasive, and less costly interventions (or even sometimes risk factor management) are more likely to have a chance at preventing or reversing the course of the disease” said Dr. Yosef Chodakiewitz, the Prenuvo radiologist leading the Hercules study. “Through the unique Prenuvo-sponsored scientific study at the Hercules Research Center, we hope to demonstrate how early detection through WB-MRI can fundamentally change the way we approach health and disease," he added.
The clinical research study, described as ambitious and unprecedented, will be conducted by the Watertown, MA-based Hercules Research Center. According to details provided, the study builds upon what Prenuvo has already achieved separately with research. To date, the company has had more than 27 academic papers and abstracts, which have been showcased at the American Academy of Neurology (AAN), International Society for Magnetic Resonance in Medicine (ISMRM), Journal of Disease and Aging and Journal of Alzheimer’s Disease, and other top associations and publications.
How Whole Body MRI Works
"There is some confusion when it comes to whole-body MRIs due to the widely different hardware employed, acquisition sequences used and radiological approaches,” said Andrew Lacy, founder and CEO of Prenuvo. He added, “The Hercules clinical research study will utilize Prenuvo’s brand of whole-body MRI based on years of clinical practice, to demonstrate the potential of this technology in becoming a cornerstone of early disease detection and personalized medicine, further validating and paving the way for a more proactive approach to healthcare.”
The Hercules clinical research study will utilize Prenuvo’s whole-body MRI scan technology to collect evidence on the efficacy of its comprehensive screening approach. Unlike traditional MRIs, which focus on a specific area of concern due to pre-existing symptoms or risk factors, Prenuvo reports that it applies a starkly different approach to MRI, leveraging the technology for proactive screening, by utilizing a combination of factors summarized here:
- Hardware and software optimized for whole-body screening: the Prenuvo scan captures over one billion data points and results in 10 times more clinical-grade images than traditional MRIs. This approach leverages the non-invasive, non-irradiating properties of MRI, combined with its multiparametric capabilities, for advanced whole-body imaging;
- Research-grade MRI machines: Delivering superior image quality for whole-body MRI screening;
- Proprietary image acquisition protocols: Developed through 15 years of clinical practice to ensure optimal data capture for a wider range of potential health issues;
- Dedicated team of specialists: Team of nurse practitioners, MRI technologists, and radiologists who are all highly trained in whole-body MRI.
With locations in New York (NY), Redwood City and Los Angeles (CA), Dallas (TX), Boca Raton (FL), Chicago (IL), Bethesda )MD) and DC metro area, Atlanta (GA), Vancouver (CAN), and a partner location in Minneapolis (MN), the company noted that it is backed by leading venture capital firms and investors in health, fitness and category-defining consumer brands, including 23AndMe CEO Anne Wojcicki, Nest founder Tony Fadell, Eric Schmidt, Cindy Crawford, Casamigos co-founder Rande Gerber, and Lasker award recipient Dr. Timothy A. Springer among others.
For more information: www.prenuvo.com, www.herculesstudy.org
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