Results Presented at San Antonio Breast Cancer Symposium Illustrate BCI’s Contribution to Advancing Clinical Care

FOR IMMEDIATE RELEASE…Dec. 8, 2015…SAN DIEGO…Biotheranostics, a leader in molecular diagnostics for cancer, announced the results of several studies being presented at the San Antonio Breast Cancer Symposium this week, including a key study focused on the development of a new Breast Cancer IndexSM (BCI) prognostic test for women with lymph nodepositive disease, and other studies reinforcing the clinical utility of BCI in predicting risk of recurrence 5–10 years post-diagnosis and likelihood of benefit from extended endocrine therapy.

Nicolas Barthelemy, president and CEO of Biotheranostics, said the studies demonstrate the growing role of BCI in advancing the care of breast cancer patients. “We are excited to disclose the development of a new BCI prognostic model for patients with lymph node positive disease,” Barthelemy said. “We’re also pleased to see additional strong confirmation of the clinical utility of BCI. These results, along with an independent study about the value of BCI in a breast cancer practice, help set BCI apart as the only molecular test that facilitates selection of women likely to benefit from extended endocrine therapy, thus potentially sparing those unlikely to benefit from adverse events and toxicities that can negatively affect their health and quality of life.”

In a study of patients from the landmark TransATAC trial, 219 primary tumor samples from estrogen receptor-positive patients with 1-3 positive lymph nodes treated with five years of endocrine therapy alone were examined. BCI was combined with tumor size and grade into a comprehensive risk score toward the development of a new BCI prognostic test for patients with lymph node positive breast cancer. Results showed that in 55 women categorized as low risk (25 percent), there were no distant recurrences within 10 years, suggesting that these women might not require adjuvant chemotherapy or extended endocrine therapy. The study (abstract No. P2-08-12) is being presented as a poster on December 10th.

Three additional studies that will be presented evaluate the potential symptom burden associated with extended endocrine treatment and provide support for the clinical utility of BCI in routine clinical care, including:

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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