Results Presented at San Antonio Breast Cancer Symposium Demonstrate Strength of Breast Cancer Index

FOR IMMEDIATE RELEASE…Dec. 9, 2014…SAN ANTONIO…Results from three studies being presented at the 37th Annual San Antonio Breast Cancer Symposium this week underscore the unique abilities of Biotheranostics’ Breast Cancer IndexSM molecular test, providing additional strong evidence of both its predictive and prognostic power.

According to Nicolas Barthelemy, president and CEO of Biotheranostics, the findings add to the growing body of research establishing the Breast Cancer Index as the “biomarker of endocrine response.” “Only about 3-5 percent of breast cancer patients in the United States benefit from extended endocrine therapy—which is associated with significant side effects and safety challenges,” Barthelemy said. “The Breast Cancer Index is distinct in that it provides molecular information that facilitates selection of women who are likely to benefit from continuing endocrine treatment beyond five years, thus potentially sparing those unlikely to benefit from adverse events and toxicities that can negatively affect their health and quality of life.”

The first study compared the Breast Cancer Index (HoxB13/IL17BR) with quantitative hormone receptor (ER and PR) expression and HER2 expression in predicting benefit from adjuvant tamoxifen therapy in estrogen-receptor positive (ER+) patients from the prospective, randomized Stockholm trial. The analysis, which included 600 patients, found that only the Breast Cancer Index (HoxB13/IL17BR) was predictive of benefit from endocrine therapy. The poster presentation (No. P3-06-06; Zhang Y, et al.), is titled “Prediction of Benefit from Endocrine Therapy in ER+ Early Stage Breast Cancer: Correlative Studies of the Breast Cancer Index HoxB13/IL17BR (H/I) ratio, ER, PR, and HER2 Expression in the Randomized Stockholm Trial.”

A second study investigated the Breast Cancer Index in the landmark TransATAC study, further demonstrating its prognostic strength in patients with ER+, lymph node-negative breast cancer. In this study, the Breast Cancer Index was a significantly better predictor of 10-year risk of distant recurrence than tumor size or tumor grade, and integration of tumor size and grade with the Breast Cancer Index did not improve the ability to predict risk of recurrence in a clinically meaningful manner. The poster presentation (No: P4-11-19; Sestak I, et al.) is titled “Integration of Breast Cancer Index (BCI) with Clinicopathological Factors for Prediction of Distant Recurrence in ER+ Breast Cancer.”

A third study evaluated the prognostic ability of the Breast Cancer Index in lymph node-positive patients. In this study of 292 patients from the NCIC CTG MA.14 trial, the Breast Cancer Index was a significant predictor of risk of distant recurrence in node-positive patients. The poster presentation (No. P6-01-10; Sgroi D, et al.), is titled “Prognostic Significance of Breast Cancer Index (BCI) in Node-Positive Hormone Receptor Positive Early Breast Cancer: NCIC CTG MA.14.”

About Breast Cancer Index

The Breast Cancer Index is a unique molecular genomic test based on its ability to inform decisions about extended endocrine treatment for ER+ breast cancer patients. It is the only test on the market that predicts which patients have a high vs. low likelihood of benefitting from extended endocrine therapy and quantifies the risk of late (>5 years post-diagnosis) breast cancer recurrence. Development of the test stems from more than 10 years of research and clinical validation designed to investigate and discover biomarkers that track the multiple cellular signaling pathways that can lead to endocrine response and breast cancer recurrence. The result is a breakthrough test that helps oncologists and patients navigate the difficult trade-off between wanting to take steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to extended endocrine therapy.

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary molecular diagnostic tests that allow treatment to be tailored to individual patients. The company’s Breast Cancer IndexSM helps oncologists make difficult decisions about extended endocrine therapy for ER+ breast cancer patients. Its CancerTYPE ID® is the most rigorously validated gene expression test for metastatic patients with diagnostic ambiguity, helping physicians determine optimal site-directed treatment regimens with the goal of improving patient outcomes. Biotheranostics, a bioMérieux company, is based in San Diego. For more information, visit www.biotheranostics.com or www.AnswersBeyond5.com. Follow BCI on Twitter at @AnswersByond5.

Breast Cancer Index Intended Use and Limitations

BCI provides a quantitative assessment of the likelihood of distant recurrence in patients diagnosed with ER+ node-negative breast cancer, and prediction of likelihood of benefit from extended (>5 year) endocrine therapy in patients who are recurrence-free after an initial 5 years of adjuvant endocrine therapy. 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.

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