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COTA, Baptist Health South Florida, and PreciseDx Announce Collaboration on the AI-Enabled Breast Cancer Recurrence Risk Assessment, PreciseBreast™

Today, COTA, PreciseDx and Baptist Health South Florida announced a collaboration to assess and validate the performance of the artificial intelligence (AI) -enabled PreciseBreast™ (PDxBr) test that predicts the likelihood of invasive breast cancer (IBC) recurrence.

One in eight women in the U.S. will be diagnosed with breast cancer in their lifetime. An accurate understanding of a patient’s prognosis is needed to inform treatment decisions. Risk assessment to determine the likelihood of breast cancer recurrence is a critical step in characterizing a cancer diagnosis. While breast cancer patients have benefited from numerous gene-expression tests in recent years, these tools have documented limitations and can be expensive. Often reporting within a two-to-four-week timeframe, gene-expression testing can lead to delayed treatment decisions that are critical to patient management.

“AI has the potential to augment human learning and improve the accuracy and precision of cancer diagnostics and treatments,” said Dr. C.K. Wang, chief medical officer, COTA. “It is critical that we evaluate these tools against the current standard of care to validate their efficacy and build trust in AI and new technologies.”

As long-term collaborators, COTA and Baptist Health South Florida will analyze the performance of PreciseDx’s clinical risk tool using curated real-world data. They will compare the results of PreciseBreast™ to traditional pathology reviews and to 21-gene assay results to validate its performance. If the validation study is successful, Baptist Health South Florida will offer this AI-enabled testing to patients with IBC with the goal of expanding access to innovations in cancer care. Additional benefits include access to results in 48 hours and an 80% reduction in cost.

Current pathology practices are manual and often subjective. The PreciseBreast™ test is designed to improve clinical decision-making with AI-derived insights that give physicians and patients a clear understanding of the risk of recurring IBC.

“AI has allowed us to take a giant leap forward in the accuracy, affordability and accessibility of tools to better understand and treat breast cancer,” said Gerardo Fernandez, M.D., co-founder and chief scientific officer of PreciseDx. “Access to COTA’s best-in-class, real-world data that provides comprehensive insights into the cancer journeys of diverse patient populations will power more advanced and accurate AI learnings.”

"This collaboration underscores our commitment to advancing cancer diagnostics with the latest AI-driven solutions,” said Manmeet S. Ahluwalia, M.D., MBA, FASCO, deputy director, Fernandez Family Foundation Endowed Chair in Cancer Research, chief of medical oncology, and chief scientific officer of Miami Cancer Institute, part of Baptist Health South Florida. “By combining state-of-the-art technology with real-world evidence, we are working to not only enhance our diagnostic precision but also improve accessibility that may ultimately empower both patients and physicians with timely, actionable insights.”

About PreciseDx®

PreciseDx® is innovating oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven disease analysis. Combining AI with our patented Morphology Feature Array® (MFA), PreciseDx provides access to unmatched disease insights and accurate, actionable intelligence for more comprehensive decision-making throughout the cancer care continuum. To learn more about PreciseDx, visit https://precisedx.ai

About PreciseBreast™

PreciseBreast™ is an early-stage invasive breast cancer risk assessment, independent of HER2, hormone, and node status. The AI-powered test utilizes standard H&E pathology slide images. Leveraging millions of data points, PreciseBreast™ analyzes, correlates, and quantifies those critical features that predict breast cancer recurrence and delivers a Risk of Recurrence Score. The test meets the rigorous Clinical Laboratory Improvement Amendments (CLIA) standards and has passed the Clinical Laboratory Evaluation Program (CLEP) Assay Validation Review by the New York State Department of Health (NYSDOH). PDxBR will be available worldwide under the brand name of PreciseBreast™. For more information, please contact precisebreast@precisedx.ai.

About Baptist Health South Florida

Baptist Health South Florida is the largest healthcare organization in the region, with 12 hospitals, more than 27,000 employees, 4,000 physicians and 200 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties. Baptist Health has internationally renowned institutes specializing in cancer care, brain and spine care, heart and vascular care and orthopedic care. In addition, it includes Baptist Health Medical Group; Baptist Health Quality Network; and The Baptist Health PineApp, a virtual health platform. Baptist Health South Florida is an academic and clinical affiliate of Florida International University Herbert Wertheim College of Medicine. A not-for-profit organization supported by philanthropy and committed to its faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and is the most awarded healthcare system in South Florida by U.S. News and World Report. For more information, visit BaptistHealth.net/Newsroom and connect with us on Facebook, X (formerly Twitter), Instagram, TikTok and LinkedIn.

About COTA, Inc.

Founded by oncologists, COTA is committed to creating a precise, patient-first approach to cancer care through the use of real-world data. The company leverages technology-supported data abstraction methods to make sense of complex, fragmented patient data from the real world. Offering the highest quality oncology real-world data from leading academic and community-based cancer centers and an advanced analytics platform, COTA partners with leading life sciences companies, providers, and payers to ensure that everyone touched by cancer has a clear path to the right care. To learn more about COTA and how to fast-track improvements in cancer care and treatment with comprehensive and diverse real-world data and analytics, visit cotahealthcare.com.

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