Press Room

September 16, 2015

Journal of the National Comprehensive Cancer Network Review Article Highlights Role of bioTheranostics’ Breast Cancer IndexSM in Optimizing Endocrine Therapy

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 BCI Breast Cancer Index is a molecular, gene expression-based test that is uniquely positioned to 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 extended endocrine therapy benefit. 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 and management 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 bioT3 Metastatic Cancer Solution combines accurate diagnosis with comprehensive biomarker information that allows improved treatment for metastatic cancer patients. bioTheranostics, a bioMérieux company, is based in San Diego. For more information, visit biotheranostics.com or AnswersBeyond5.com. Follow BCI on Twitter at @AnswersByond5.