Study Results from COTA, PreciseDx, and Baptist Health South Florida Confirm Novel AI Test, PreciseBreast is Equivalent to Oncotype DX at Predicting Breast Cancer Recurrence

Findings to be Presented at the San Antonio Breast Cancer Symposium

NEW YORK, Dec. 9, 2024 /PRNewswire/ -- COTA Inc., a leader in real-world data (RWD) and analytics for oncology, PreciseDx, an innovator in AI-powered digital pathology focused on oncology diagnostics, and Baptist Health South Florida today announced new study results validating the artificial intelligence (AI)-enabled PreciseBreast™ test is equivalent to the Oncotype DX test at predicting breast cancer recurrence. The research will be presented at the San Antonio Breast Cancer Symposium (SABCS) during Poster Session 2 on December 11, 2024.

Breast cancer accounts for 32% of all new cancer diagnoses in women, and one in eight women in the U.S. will be diagnosed with breast cancer in their lifetime. Amidst strained healthcare resources and rising breast cancer incidence, breast cancer diagnostics tools that harness the power of real-world data (RWD) and artificial intelligence (AI) can be powerful for improving early detection, enhancing diagnostic accuracy, and reducing time to treatment, all crucial components of optimized patient care. This news comes after COTA, PreciseDx and Baptist Health South Florida announced a collaboration earlier this year 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.

PreciseBreast is an AI-enabled digital test that integrates demographic and pathology data—such as age, tumor size, stage, and lymph node status—with biomarkers of early-stage invasive breast cancer to assess the risk of recurrence. After demonstrating improved risk discrimination on a cohort at Mount Sinai Health System, this study extended these findings to a diverse cohort of 425 patients from Miami Cancer Institute and Baptist Health South Florida, using COTA's curated RWD. The results of this study showed equivalence when comparing PreciseBreast against Oncotype DX based on six year outcome data. The results of this study demonstrate PreciseBreast was equivalent to Oncotype DX:

• Identifying Recurrence: Equivalent Negative Predictive Value (NPV) of 93%
• Risk Classification and Treatment Decisions: 79% PreciseBreast low risk, 81% Oncotype DX low/intermediate risk, with comparable avoidance of chemotherapy.
• Event Confirmation: Of the patients who experienced recurrences, PreciseBreast correctly identified 38% as high risk versus 35% for Oncotype DX.

"AI-powered tools may have the potential to successfully augment medical practice. The results from this study demonstrate the great potential that PreciseBreast holds to fundamentally enhance cancer diagnostics and treatment precision," said Dr. C.K. Wang, chief medical officer, COTA. "Using research-grade RWD to train and validate AI technology is critical for building trust in AI and ensuring its responsible integration into oncology practice." 

Despite advances in gene-expression tests over the years, the Oncotype DX test remains expensive and requires multiple weeks of waiting to report. PreciseBreast is 20% of the cost with a 48-hour reporting time, which could limit patient anxiety and provide important information regarding risk of recurrence which informs treatment decisions. By utilizing COTA's extensive patient data from Baptist Health South Florida, the researchers were able to validate that the PreciseBreast test is equivalent to the Oncotype DX test at assessing the risk of breast cancer recurrence after six years.

This study, as compared to existing gene-expression test data, provides physicians with a timely and more comprehensive understanding of a patient's breast cancer risk of recurrence, helping oncologists make more informed decisions about a patient's optimal treatment pathway.

"This is a big step forward in bringing new technology to breast cancer patient care," said PreciseDx CEO Eric Converse. "It's critical that providers understand more about their patient's breast cancer as early as possible to ensure timely treatment and improve their outcomes. With the ultimate goal of providing care decision support data that works seamlessly in the pathology workflow, returns results in less than 48 hours and costs a fraction of the current technology, PreciseBreast optimizes, and could ultimately replace, gene-expression testing. Physicians and their patients will now benefit from the findings being presented during the SABCS in December."

"For comprehensive care planning, gaining a more complete understanding of a breast cancer diagnosis is crucial," said Reshma Mahtani, DO, chief of breast medical oncology, Miami Cancer Institute, Baptist Health South Florida, and author of the study. "It is imperative, and often a complicated process, for physicians to develop care plans for their patients. PreciseBreast further details valued information that can help patients and physicians in shared decision making."

About PreciseDx®
Founded in 2020, PreciseDx is leveraging AI-powered digital pathology in oncology diagnostics to predict the risk and recurrence of cancer. Combining AI-image analysis with our Morphology Feature Array® (MFA), PreciseDx is the first company to use AI and machine learning to reveal unmatched disease insights and accurate, actionable intelligence for more comprehensive decision-making. PreciseDx has raised $31.5M in Series B funding led by Eventide Asset Management. To learn more, visit PreciseDx on our website and on LinkedIn.

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 [email protected].

About Baptist Health South Florida
Baptist Health South Florida is the largest healthcare organization in the region, with 12 hospitals, more than 28,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices spanning 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. A not-for-profit organization supported by philanthropy and committed to its 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 & 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 using 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.

Media Contacts

For COTA
Jared Rosen
[email protected]

For PreciseDx
Audrey Mann Cronin
[email protected]

SOURCE PreciseDx