PreciseDx's AI Charts New Path in Breast Cancer Prognosis

NEW YORK, NY – December 04, 2025 – As the oncology community prepares to gather for the annual San Antonio Breast Cancer Symposium (SABCS), one company is poised to showcase significant strides in the fight against breast cancer. New York-based PreciseDx is set to present compelling new data on its artificial intelligence-powered diagnostic test, PreciseBreastⓇ. This marks a critical milestone in the company's journey from a promising prototype to a commercially viable tool that could reshape how clinicians assess cancer recurrence risk and guide patient treatment.

PreciseDx will unveil findings from three separate studies at the prestigious symposium, each designed to further validate the test's accuracy and expand its clinical applications. The presentations represent a culmination of years of development and a strategic push toward market entry, highlighting the growing momentum behind AI's role in pathology. For investors and industry leaders, PreciseDx's progress offers a compelling case study in navigating the complex path to commercialization in the highly competitive and regulated field of medical diagnostics.

Beyond the Microscope: A New Paradigm in Pathology

For decades, the cornerstones of cancer diagnosis have been the pathologist's microscope and, more recently, complex genomic testing. PreciseDx aims to augment this paradigm with a powerful, AI-driven approach. The PreciseBreast test operates on the company’s proprietary OncoIntelligence™ platform, which analyzes digital images of standard H&E stained biopsy slides—the same tissue samples already prepared for every cancer patient.

The AI algorithm examines the morphology, or the intricate architecture and appearance of cells and their surrounding tissue, to identify subtle patterns that are invisible to the human eye but highly predictive of a tumor's future behavior. By combining this rich visual data with key clinical factors, the platform generates a “PreciseBreast Score” that stratifies patients into low or high-risk categories for cancer recurrence.

This methodology presents a stark contrast to incumbent gene expression tests, such as Oncotype DX, which analyze a tumor's genetic activity. While valuable, these tests are often expensive, with costs running into thousands of dollars per patient, and can take weeks to return results. PreciseDx claims its morphology-based test can deliver results in a matter of hours and at approximately 30% of the cost. This combination of speed and cost-efficiency is a central pillar of its value proposition, potentially democratizing access to advanced prognostic tools and alleviating the patient anxiety associated with long waits for critical information.

Building a Foundation of Clinical Evidence

Translating an innovative algorithm into a trusted clinical tool requires a rigorous and transparent validation process. PreciseDx has been methodically building its case through a series of studies with leading cancer centers. Earlier research published in journals like Breast Cancer Research and Clinical Breast Cancer established the test's analytical and clinical performance.

A pivotal moment came at the 2024 SABCS, where a study conducted with Baptist Health Miami Cancer Institute demonstrated that PreciseBreast was equivalent to Oncotype DX in assessing recurrence risk over a six-year period. The findings showed it could help a comparable number of patients avoid unnecessary chemotherapy while correctly identifying a slightly higher percentage of patients who ultimately experienced a recurrence.

The upcoming presentations in San Antonio aim to build directly on this foundation. One abstract, presented by PreciseDx's co-founder and Chief Medical Officer, Dr. Michael J. Donovan, will detail the test's validation using biopsy specimens, a crucial step for integrating it early in the diagnostic workflow. Another, from a collaboration with UCLA, will explore a novel application for phenotyping triple-negative breast cancer (TNBC)—a notoriously aggressive and difficult-to-treat subtype—to better predict risk and therapy response.

Perhaps most significantly for its commercialization journey, a third presentation will come from an independent, real-world evaluation by Lankenau Medical Center/Main Line Health. This study focuses on the test’s use in HR+, HER2- early breast cancer, the most common subtype. “We're particularly excited about the independent, real-world experience at Lankenau Medical Center,” shared Eric Converse, CEO of PreciseDx. “These results build on our prior publications...by demonstrating the ability to use the patient's biopsy specimen to risk stratify as well as advancing our understanding of patients with triple negative breast cancer.”

Navigating the Crowded AI Diagnostics Market

PreciseDx is entering a dynamic and increasingly crowded market. Giants in the digital pathology space, like Paige.AI and PathAI, have already secured significant funding and landmark regulatory approvals. Paige, for instance, has received FDA De Novo approval for its prostate cancer detection AI and Breakthrough Device Designation for a breast cancer tool. PathAI has established major commercial partnerships with entities like Quest Diagnostics for its AI-powered biomarker quantification algorithms.

In this competitive landscape, PreciseDx's differentiation on cost and speed is critical. While it has achieved CLIA approval and passed the New York State Department of Health’s rigorous review—allowing it to operate as a laboratory-developed test (LDT)—it has not yet announced broader FDA marketing authorization. This regulatory path is a key hurdle for any diagnostic company seeking widespread adoption and reimbursement, and will be a crucial milestone to watch on its road to profitability.

However, the company's strategic funding and partnerships signal strong investor confidence. PreciseDx has raised a total of $42.8 million, including a recent $11 million round in June 2025 led by Eventide Asset Management with participation from the venture arms of Merck, Philips, Quest Diagnostics, and Labcorp. This backing from established healthcare leaders not only provides capital but also validates the technology and opens doors for future integration and commercial collaborations.

With a commercial launch planned for 2026, this capital is being deployed to expand clinical data collection and forge the strategic partnerships necessary for market entry. Collaborations with institutions like Baylor Scott & White Health, in addition to UCLA and Main Line Health, are essential for generating the data needed to convince clinicians, hospital administrators, and payors of the test's value. The company's origin from Mount Sinai Health System also provided it with a foundational dataset to train its algorithms, a common but powerful strategy in the medical AI space. As PreciseDx moves toward its launch, its ability to successfully navigate the regulatory environment and leverage its powerful network of investors and clinical partners will ultimately determine its success in translating a promising prototype into a profitable and impactful clinical standard.