Molecular test facilitates more personalized treatment, helping determine which patients with early stage, ER+ breast cancer are likely to benefit from extended endocrine therapy

FOR IMMEDIATE RELEASE…Sept. 16, 2015…SAN DIEGO…A review article published in the Journal of the National Comprehensive Cancer Network examining the evolving evidence for optimization of endocrine therapy in breast cancer patients highlights the unique ability of Biotheranostics’ Breast Cancer IndexSM (BCI) molecular test to inform decisions regarding extended adjuvant endocrine therapy in patients with early stage, estrogen receptor-positive (ER+) breast cancer.

In the article, authors Amelia Zelnak, M.D., and Ruth O’Regan, M.D., discuss the critical issue of determining which patients need extended adjuvant endocrine therapy and the value of molecular profiling. Authors cited key data from the TransATAC study demonstrating the prognostic ability of BCI in identifying which patients are at risk of late recurrence (>5 years post-diagnosis), as well as results from the NCIC MA.17 trial demonstrating the test’s ability to determine likelihood of benefit from extended endocrine therapy. BCI is highlighted as the “only molecular assay to have been evaluated in trials in which patients received extended adjuvant therapy.”

“Multiple studies have shown benefit for extending hormonal therapy to 10 years in patients with early stage, ER+ breast cancer, but endocrine therapy increases the risk of major safety issues and side effects,” said Dr. O’Regan, Professor and Division Head of Hematology and Oncology, Department of Medicine, University of Wisconsin School of Medicine and Public Health. “The use of molecular profiling clearly allows a more individualized approach to treating breast cancer, but only recently has an assay been available to determine which patients will truly benefit from extended endocrine therapy. Use of BCI will be critical to improving long-term outcomes for early stage, ER+ breast cancer. This could be practice-changing for some doctors.”

Nicolas Barthelemy, President and CEO of Biotheranostics, said: “Optimal duration of endocrine therapy is a key question in breast cancer treatment. This important review article highlights the strong research supporting BCI’s clinical utility, and its unique and growing role in the management of patients with early stage breast cancer.”

About Breast Cancer Index

BCI is a molecular, gene expression-based test uniquely positioned to help identify patients best suited for extended endocrine treatment. It is the only validated, commercially available test that provides prognostic risk of late recurrence (5-10 years post-diagnosis), as well as prediction of likelihood of benefit from extended endocrine therapy. The breakthrough test 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. BCI was granted Medicare coverage in October 2014.

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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