Hologic’s AI-Powered Mammography Technology Flagged a Third of Breast Cancer Cases Initially Interpreted as Negative in Study of 7,500 Screening Exams

Key Terms

digital breast tomosynthesis medical

A medical imaging method that creates a series of thin X‑ray “slices” of the breast and reconstructs them into a 3‑D picture, similar to flipping through pages instead of looking at a single flat photo. It matters to investors because it can improve cancer detection and reduce follow‑up tests, which affects demand for imaging machines, training and software, reimbursement rates, and the financial performance of healthcare providers and device makers.

3D mammography medical

A breast imaging technique that takes many thin X-ray pictures from different angles and combines them into a three‑dimensional view, similar to flipping through pages of a book to see internal layers. It matters to investors because higher accuracy, faster read times, and wider adoption can drive sales of imaging machines, service contracts, and reimbursement revenue, while also affecting market demand and regulatory scrutiny in the medical device and healthcare sectors.

invasive ductal carcinomas medical

Invasive ductal carcinomas are cancers that begin in the milk-carrying ducts of the breast and then grow into surrounding tissue; think of a small leak in a pipe that spreads into nearby walls. For investors, they matter because incidence, treatment advances, diagnostic improvements, and regulatory approvals directly affect demand for drugs, medical devices, testing services, and healthcare spending, influencing the revenues and prospects of companies across the medical and biotech sectors.

invasive lobular carcinomas medical

A type of breast cancer that begins in the milk-producing glands (lobules) and tends to grow in thin, single-file strands that can be harder to spot on scans. It matters to investors because this distinct growth pattern and biology can affect how well treatments, diagnostic tests, and clinical trials perform, influencing a drug’s development path, regulatory chances, and the potential market for therapies or detection tools.

lymph node-positive cancers medical

Cancer described as lymph node-positive means tumor cells have spread to nearby lymph nodes, the small 'filter' glands that help the body fight infection. For investors, this matters because lymph node involvement usually signals a more advanced disease stage, can change the course and cost of treatment, affects clinical trial design and regulatory decisions, and therefore influences the commercial outlook for therapies and diagnostics.

grade I invasive carcinomas medical

Grade I invasive carcinomas are cancers whose cells still look relatively normal and tend to grow and spread slowly compared with higher-grade tumors; think of them as the mildest level on a severity scale. For investors, this matters because lower-grade disease usually means different treatment needs, better patient outcomes and smaller immediate market demand for aggressive therapies, which can affect drug development paths, regulatory decisions and long-term revenue forecasts.

retrospective analysis technical

A retrospective analysis examines existing records, data or outcomes from past events to determine what happened and why, and to measure how effective earlier decisions or treatments were. For investors, it is useful because it reveals real-world performance, risks or side effects that weren’t apparent at the time—like rereading past customer reviews before buying—helping refine forecasts, adjust valuations and manage future risk.

false-negative cases medical

False-negative cases occur when a medical test or diagnostic fails to detect a disease or condition that is actually present, so the result incorrectly indicates 'no' when the correct answer is 'yes'. For investors, false negatives can mask the true size of a patient population, mislead trial outcomes or regulatory assessments, and create unexpected risks or costs—like a smoke detector that stays silent during a real fire, giving a false sense of safety until problems suddenly surface.

Retrospective analysis at top-tier medical facility highlights AI solution’s ability to help spot previously missed cancers and correctly localize suspicious areas on mammograms

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX), a leading medical technology company dedicated to improving women’s health, today announced new data that highlights how the company’s advanced AI-powered mammography solution can aid in detecting more breast cancers.

Hologic’s AI-Powered Mammography Technology

“At Hologic, we are constantly pushing ourselves to innovate and enhance the quality and reliability of our technologies,” said Mark Horvath, President of Breast and Skeletal Health Solutions. “This study underscores AI’s potential to uncover cancers that might otherwise remain hidden, while also giving us critical insights to guide the development of future innovations. As we continue to advance this technology based on customer and provider feedback, we’re excited to see its impact in real-world settings.”

In a new study¹ published in the American Journal of Roentgenology, researchers at Massachusetts General Hospital in Boston performed a retrospective analysis of 7,500 digital breast tomosynthesis (3D mammography) screening exams using Hologic’s Genius AI^® Detection solution. Among the 7,500 exams performed between 2016 and 2019, there were 100 false-negative cases, which are mammograms read as negative but followed by a breast cancer diagnosis within the next year. The Genius AI Detection solution marked approximately one-third (32%) of these cases as including areas of suspicion, accurately identifying the location where breast cancer was subsequently diagnosed.

Of the 500 breast cancer cases previously identified by radiologists, the Genius AI Detection technology flagged almost 90% and correctly localized their locations. The AI technology was more likely to flag invasive ductal carcinomas and lymph node-positive cancers in the study. It was less likely to flag invasive lobular carcinomas and grade I invasive carcinomas.

One instance of a false-negative case flagged by AI cited in the study involved a 54-year-old woman whose results were initially interpreted as negative. Eleven months later, she returned to her doctor after noticing a lump in her left breast and was diagnosed with grade 1 invasive ductal carcinoma. On retrospective evaluation of the initial screening mammogram, the AI algorithm marked and correctly localized the area where the cancer was located as suspicious.

“In this study, not only did the AI identify the case as suspicious and warranting additional review, but it also correctly localized the region of interest,” said Dr. Manisha Bahl, MD, MPH, Associate Director of Quality for Breast Imaging at Mass General Brigham and Associate Professor of Radiology at Harvard Medical School. “While additional research is needed, these findings are promising and highlight AI’s tremendous potential to redefine breast cancer detection in the years ahead.”

Study Limitations

This study was performed at a single academic medical center with a predominantly Caucasian patient population and was conducted with Hologic’s Genius AI Detection 2.0 software, and the results may not be generalizable to other practice settings or to other AI-based algorithms. Additionally, the small sample sizes within certain subgroup limit the statistical power and generalizability of the subgroup analyses. The study also did not evaluate the impact of AI on patient outcomes or its integration into real-world clinical workflows.

About Genius AI Detection Solution

Hologic’s Genius AI Detection solution is an innovative mammography screening technology designed to locate lesions likely to represent breast cancer. Suspicious areas are highlighted at radiologists’ workstations for concurrent reading to support smart, decisive interpretation. Hologic's deep learning algorithm is fed by the accumulation of a large, diverse patient base, providing rich insight and intelligence. For more information, please visit Genius AI Detection Technology.

About Hologic, Inc.

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

Hologic, The Science of Sure and Genius AI are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

References

¹ Bahl M, Kim K, Kim H, Alkhadrawi A, Do S. Commercial Artificial Intelligence (AI) Tool for Screening Digital Breast Tomosynthesis: Factors Associated With AI-Based Breast Cancer Detection. AJR Am J Roentgenol. 2025 Dec 3. doi: 10.2214/AJR.25.33792. Epub ahead of print. PMID: 41334895.

SOURCE: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251216784478/en/

Media Contact

Bridget Perry

Senior Director, Corporate Communications

(+1) 508.263.8654

bridget.perry@hologic.com

Investor Contact

Michael Watts

Corporate Vice President, Investor Relations

(+1) 858.410.8514

michael.watts@hologic.com

Source: Hologic, Inc.