• Completed assessment of more than 2,800 patients highlights the profound impact of the test in helping to predict the likelihood of extended endocrine therapy benefit for patients with HR+ breast cancer to support more informed care decisions

MARLBOROUGH, Mass. / May 22, 2025 / Business Wire / Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., today announced new data demonstrating the significant clinical impact of the Breast Cancer Index^® (BCI^®) test, which will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025.

“These data highlight the critical role the Breast Cancer Index test plays in guiding extended endocrine therapy decisions for women with early-stage, hormone receptor-positive (HR+) breast cancer,” said Jennifer Schneiders, PhD, President of Diagnostic Solutions at Hologic. “As the only genomic test recognized by clinical practice guidelines to inform such decisions, the BCI test is a powerful tool in personalized care. These findings reinforce our commitment to delivering clinically validated diagnostics that support treatment decisions based on each patient’s unique tumor biology.”

During the meeting, Hologic will share the latest analysis of the prospective, multi-center BCI Registry Study, which evaluated how the BCI test influences clinical decision-making for extended endocrine therapy in patients with early-stage, HR+ breast cancer. Building on initial published data, this assessment reflects an even more comprehensive analysis of more than 2,800 patients. The latest data showed BCI testing led to a change in treatment recommendations for about 4 in 10 cases. Importantly, physician confidence in treatment recommendations also increased and patients reported feeling more comfortable with their treatment decisions, citing fewer concerns about cost, drug safety and preference related to extended endocrine therapy benefit.¹

“Incorporating the Breast Cancer Index test into the conversation about extended endocrine therapy helps doctors and patients make decisions with more confidence and comfort,” said Tara Sanft, MD, Associate Professor of Medicine at Yale School of Medicine and primary investigator of the new study. “As oncologists, we often look at clinical and pathologic factors to assess our patients’ risk of recurrence, but these factors are not enough to tell us whether longer treatment is likely to reduce that risk and may lead to misguided recommendations. Genomic testing with the BCI test allows us to determine which women are likely to derive benefit from extended endocrine therapy to make more informed, shared decisions with our patients.”

The data presentations at ASCO 2025 focusing on the BCI test include:

• Prospective Decision Impact Study of the Breast Cancer Index: Results from the BCI
  Registry Study (Abstract #531/Poster Board #124)
  Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
  The expanded assessment of the BCI Registry Study found that incorporating the BCI test into clinical practice significantly influenced extended endocrine therapy decisions for early-stage, HR+ breast cancer patients.¹

• Assessment of Ovarian Function Suppression (OFS)-Containing Adjuvant
  Endocrine Therapy in Premenopausal Women by Breast Cancer Index (Abstract #557/Poster Board #150)
  Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
  These translational data from the landmark Tamoxifen and Exemestane Trial (TEXT) trial further validate the ability of the BCI test to assess risk of overall and late distant recurrence in premenopausal women with early-stage, HR+ breast cancer.²*

About the Breast Cancer Index Test

The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO^® Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) acknowledge the Breast Cancer Index test as a biomarker to help inform extended endocrine treatment decisions.^3,4 It is the only test recognized by guidelines to predict the likelihood of benefit from extended endocrine therapy.^3,4

The Breast Cancer Index test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a laboratory-developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory. For more information, visit www.breastcancerindex.com.

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’s and its subsidiaries’ 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.

*Note: Incorporation of refined risk estimates in the results reported by the Breast Cancer Index test are pending appropriate regulatory approvals.

For the Breast Cancer Index Intended Use and Limitations, visit www.breastcancerindex.com.

Hologic, The Science of Sure, Breast Cancer Index, BCI and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective owners.

References

¹Sanft TB, Siuliukina N, O’Neal B, Anderson AKL, Jankowitz RC, Pegram MD, Diab S, Zhang Y, Treuner K, O’Shaughnessy JA. Prospective Decision Impact Study of the Breast Cancer Index: Results from the BCI Registry Study. Poster presented at: 2025 American Society of Clinical Oncology Annual Meeting; May 30-June 3; Chicago, IL.

²O’Regan RM, Ren Y, Zhang Y, Siuliukina N, Schnabel CA, Kammler R, Viale G, Dell’Orto P, Pagani O, Walley BA, Fleming GF, Francis PA, Loi S, Colleoni M, Treuner K, Regan MM. Assessment of ovarian function suppression (OFS)-containing adjuvant endocrine therapy in premenopausal women by Breast Cancer Index. Poster presented at: 2025 American Society of Clinical Oncology Annual Meeting; May 30-June 3; Chicago, IL.

³Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.4.2025. ^© National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April, 17, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

⁴Andre F et al. J Clin Oncol. Published online April 19, 2022. DOI: 10.1200/JCO.22.00069. Referenced with permission from the American Society of Clinical Oncology (ASCO^® Clinical Practice Guideline) Clinical Practice Guideline Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer.^© American Society of Clinical Oncology. 2025. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs.org/jco/special/guidelines. ASCO makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way.