On May 22, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported 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) (Free ASCO Whitepaper) Annual Meeting on June 2, 2025 (Press release, Hologic, MAY 22, 2025, View Source [SID1234653344]).

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"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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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.