In one test, BCI combines two complementary gene-expression signatures to assess proliferative and estrogen signaling pathways1-3

BCI Predictive

Reports the individualized likelihood of benefit from extended endocrine therapy4

  • Quantitative molecular assessment of estrogen signaling pathways
  • Genes: HoxB13/IL17BR (H/I)
  • Binary result (HIGH/LOW)

BCI Prognostic

Reports the individualized risk of late distant recurrence of breast cancer (Years 5 - 10)2,3,5

  • Algorithmic combination of Molecular Grade Index (MGI: proliferation) and HoxB13/IL17BR: estrogen signaling pathway
  • Genes: BUB1B, CENPA, NEK2, RACGAP1, RRM2, H/I
  • Numerical result reported on a continuous curve (delineated by HIGH/LOW risk categories)
  • For N1 patients: Risk is calculated by combining this BCI gene expression signature with tumor size and tumor grade

References
  1. Ma X-J, et al. Clin Cancer Res. 2008;14:2601-2608.
  2. Sgroi DC, et al. Lancet Oncol. 2013;14:1067 – 76.
  3. Zhang Y, et al. Clin Cancer Res. 2013;19:4196-4205.
  4. Sgroi DC, et al. J Natl Cancer Inst. 2013;105:1036-1042.
  5. Zhang Y, et al. J Clin Oncol 34, 2016 (suppl abstr 541).<

Breast Cancer Index Intended Use and Limitations

The Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test is intended for use in patients diagnosed with estrogen receptor-positive (ER+), lymph node-negative (LN-) or lymph node positive (LN+; with 1-3 positive nodes) early-stage, invasive breast cancer, who are distant recurrence-free. BCI provides: 1) a quantitative assessment of the likelihood of both late (post-5 years) and overall (0-10 year) distant recurrence following an initial 5 years of endocrine therapy (LN- patients) or 5 years of endocrine therapy plus adjuvant chemotherapy (LN+ patients), and 2) prediction of likelihood of benefit from extended (>5 year) endocrine therapy. 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. lt has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. lt should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high complexity clinical laboratory testing.