Clarity from the Start

†Not currently available to order

The features and results of the Breast Cancer Index Test, to the extent they differ from the information found on the BreastCancerIndex.com website, including, but not limited to, the features concerning adjuvant endocrine therapy and ovarian function suppression: (i) are not currently available for clinical use; (ii) will be made available only after all required internal validations and regulatory requirements have been met; and (iii) is being provided herein for informational purposes only, and shall not be deemed to be an offer of availability.

The Breast Cancer Index Intended Uses and Limitations
The Breast Cancer Index Risk of Recurrence & Extended Endocrine Benefit Test (BCI) is indicated for use in women diagnosed with hormone receptor-positive (HR+), lymph node-negative (LN-) or lymph node-positive (LN+; with 1-3 positive nodes) early-stage, invasive breast cancer, who are distant recurrence-free. The BCI test provides: 1) a quantitative estimate of the risk for both late (post-5 years from diagnosis) distant recurrence and of the cumulative distant recurrence risk over 10 years (0-10y) in patients treated with adjuvant endocrine therapy (LN-patients) or adjuvant chemoendocrine therapy (LN+ patients), and 2) prediction of the 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, 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 Improvement Amendments of 1988 to perform high complexity clinical laboratory testing.