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The Leading Biomarker for Extended Endocrine Therapy Decision-Making
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the ASCO® Clinical Practice Guideline reinforce the Breast Cancer Index test as the only genomic assay to predict which patients with early-stage, HR+, HER2- breast cancer are likely to benefit from extension of adjuvant endocrine therapy beyond five years.1,2
Predictive ability of the BCI test is supported in 5 studies including more than 4,700 early-stage, HR+ breast cancer patients with up to three positive nodes.3-7
The BCI test is a unique, proprietary genomic assay that helps inform the appropriate duration of endocrine therapy by reporting two critical results:
- Is the patient likely to benefit from extended endocrine therapy?
- What is the patient's individual risk of late distant recurrence (5-10 years post-diagnosis)?
NEW: Bringing Clarity from the Start
A new full 0-10 year BCI report option unlocks additional insights to help providers with earlier personalized endocrine therapy planning.
Navigating New Breast Cancer Index® Testing Options
The Breast Cancer Index Test is the established test for extended endocrine therapy decisions, now with new order options and test results to help set clear expectations around endocrine therapy from the beginning.
The BCI Test is Changing Care — For Good
Data suggests a significant proportion of early-stage, HR+, HER2- breast cancer survivors may be over- or under-treated without Breast Cancer Index testing.8
Multiple studies have demonstrated a modest benefit of extended endocrine therapy in reducing risk of recurrence for women with early-stage, HR+, HER2- breast cancer.3-7 However, longer treatment is associated with significant potential side effects and adverse events, and not all women benefit.3-8, 19-21 Only the BCI test is guideline-recognized to predict which patients are likely to benefit from extension of endocrine therapy beyond five years.1,2
In a decision impact study, providers changed their extended endocrine therapy treatment recommendations for 40% of patients following BCI testing.8 Who could you be missing?
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From screening to survivorship, Hologic’s innovative and trusted breast health solutions help healthcare providers support women through their entire breast health journey. We apply cutting-edge science to accelerate discovery, improve efficiency and continually sharpen precision.
Five Years of Exclusive National Guideline Recognition for the Breast Cancer Index Test
Following the 2026 update, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the ASCO® Clinical Practice Guideline reinforce the BCI test as the only genomic assay to predict which patients are likely to benefit from extension of adjuvant endocrine therapy beyond five years.1,2
Recognized for early-stage, HR+, HER2- breast cancer patients with node-negative or -positive (up to three positive nodes) disease, regardless of treatment with TAM, AI, or TAM followed by AI.1,2
Guideline Recognition
NCCN Guidelines®1
NCCN BINV-N (4 of 5)1: Treatment Implications of the Breast Cancer Index (BCI)
- In secondary analyses of the MA.17, Trans-aTTom, and IDEAL trials, patients with HR-positive, pT1–T3, pN0 or pN1 tumors (1-3 positive lymph nodes) who had a BCI (H/I) high demonstrated significant improvements in DFS when adjuvant endocrine therapy was extended, compared to the control arm.
- Patients with BCI (H/I) low demonstrated a lower risk of distant recurrence (compared to BCI [H/I] high) and no significant improvement in disease-free survival (DFS) or OS compared to the control arm in terms of extending endocrine therapy duration.
- For patients with HR-positive, HER2-negative, and pN1 tumors (1-3 positive lymph nodes), an optimized BCI model integrating tumor size and grade is prognostic for distant recurrence at 10 years.
ASCO® Clinical Practice Guideline2
BCI may be offered to patients with 0-3 positive nodes who received 5 years of endocrine therapy without evidence of recurrence to guide decisions about extended endocrine therapy
- Clinician may offer the BCI test to guide decisions about extended endocrine therapy with either tamoxifen, an Al, or a sequence of tamoxifen followed by Al
- OncotypeDX, EndoPredict, Prosigna, Ki67 and IHC4 are identified as having insufficient evidence to guide decisions about extended endocrine therapy
Predictive Ability Supported in Over 4,700 Patients
The BCI genomic assay is the established test for extended endocrine therapy decision-making, with consistent predictive performance across 5 studies and over 4,700 patients.3-7
* Time-dependent DR analysis >4y post-randomization; primary RFI endpoint not met due to significant powering challenges; Only HER2- subset demonstrated significant treatment to biomarker interaction
† For patients disease-free at year five
Across studies, patients identified as a YES (likely to benefit) experienced ~2/3 relative risk reduction by continuing endocrine therapy for a full 10 years.3-7 Patients identified as NO (not likely to benefit) did not experience statistically significant benefit from continuing endocrine therapy beyond five years.3-7
Beyond Extended Endocrine Therapy
New data support full primary and extended adjuvant endocrine therapy planning from the start with BCI testing.10-12
Proven Clinical Impact
The Breast Cancer Index test has been utilized by over 9,500 providers.13 Based on a decision impact study, provider treatment recommendations related to extended endocrine therapy (EET) changed for 40% of patients following BCI testing.8
Data suggests that a significant number of patients may be over- or under-treated without Breast Cancer Index testing:
Speakers are consultants for Biotheranostics, Inc. Statements reflect speakers' own views and interpretations.
Predictive Results to Help You Treat More Confidently
39% of physicians felt more confident in their EET recommendations following BCI testing.8
Increase Patient Comfort and Compliance
45% of patients changed their preference for extended endocrine therapy following BCI testing.8
94% of patients said they “would feel more motivated to stay committed to taking their medication as prescribed if a genomic test evaluating their specific tumor biology suggested a longer duration of anti-estrogen treatment was likely to help reduce their risk of metastatic recurrence."18
Speaker is a paid patient advocate for Biotheranostics, Inc. Statements reflect speakers' own views and interpretations.
Results That Make an Impact
Endocrine therapy and associated side effects have a significant impact on women’s lives.19-21 Use the appropriate tool to determine the optimal duration of treatment for her.
Gain Commitment from the Beginning
Learn more about how BCI testing can help set clear expectations around endocrine therapy from the start.
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Breast Cancer Index Test Intended Use and Limitations
The Breast Cancer Index (BCI) test is a polymerase chain reaction (PCR) based gene expression test which analyses two gene expression signatures from formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained sections on glass slides via macrodissection. The gene expression signatures include the Molecular Grade Index (MGI), a five-gene signature, and the HOXB13/IL17BR (H/I), a two-gene ratio signature. The test is indicated for use in women diagnosed with early-stage hormone receptor-positive (HR+), lymph node-negative (N0) or lymph node-positive (N1; 1-3 positive nodes) invasive breast cancer. The BCI test provides a quantitative estimate of overall (years 0-10) and late (years 5-10) distant recurrence risk and informs the likelihood of endocrine therapy benefit for women who are distant recurrence-free.
BCI results are adjunctive to the ordering physician’s workup; treatment decisions require correlation with all other clinical findings. This test was developed, and its performance characteristics determined by Biotheranostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes and should not be regarded as experimental or investigational. How this information is used to guide patient care is the responsibility of the treating provider. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high complexity clinical laboratory testing.
© 2026 Hologic, Inc. All rights reserved. Hologic, Biotheranostics, Breast Cancer Index, BCI, Clarity from the Start, and associated logos are U.S. trademarks and/or registered trademarks of Hologic, Inc. and/or Biotheranostics, Inc. All other trademarks are the property of their respective owners.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 10, 2026. 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.
- Andre F, et al. J Clin Oncol. 2022;40(16):1816-1837. Referenced with permission from the American Society of Clinical Oncology (ASCO®) Clinical Practice Guideline Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology. 2026. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs.org/jco/special/guidelines [ascopubs.org]. ASCO 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.
- Zhang Y, et al. Clin Cancer Res. 2013;19(15):4196-4205.
- Sgroi DC, et al. J Natl Cancer Inst. 2013;105(14):1036-1042.
- Bartlett JMS, et al. Clin Cancer Res. 2022;28(9):1871-1880.
- Noordhoek I, et al. Clin Cancer Res. 2021;27(1):311-319.
- Mamounas EP, et al. Clin Cancer Res. 2024;30(9):1984-1991.
- Sanft TB, et al. J Natl Compr Canc Netw. 2024;22(2):99-107.
- Simon RM, et al. J Natl Cancer Inst. 2009;101(21):1446-1452.
- Jilderda MF, et al. Clin Cancer Res. 2025;3;31(11):2222-2229.
- Jilderda MF, et al. npj Breast Cancer. 2026;12;21.
- O'Regan RM, et al. Breast. 2026;86:104714.
- Data on file.
- Schroeder B, et al. NPJ Breast Cancer. 2017;3:28.
- Zhang Y, et al. Clin Cancer Res. 2017;23(23):7172-7224.
- Data on file; pulled from raw, unpublished data in the MGH validation study (Zhang et al. Clin Cancer Res. 2017).
- Chuy V, et al. SABCS. 2025. Poster [#PS3-07-24].
- Data collected from 192 early-stage, HR+ breast cancer patients in an online survey conducted by Living Beyond Breast Cancer.
- Davies C, et al. Lancet Oncol. 2013;381:805-816.
- Goss PE, et al. N Engl J Med. 2016;375(3):209-219.
- Jennifer Carr, Jaime DePolo. Side Effects of Hormonal Therapy for Breast Cancer. BreastCancer.org. Hormonal therapy side effects. Breastcancer.org. Updated June 11, 2026. Accessed July 10, 2026. https://www.breastcancer.org/treatment/hormonal-therapy/side-effects
