Press Room

February 26, 2015

Study Underscores Value of Biotheranostics’ Breast Cancer IndexSM in Informing Decisions about Long-Term Endocrine Therapy & Assessing Risk of Late Recurrence

Miami Breast Cancer Conference Study & Workshop Reinforce Clinical Utility of Test Along the Continuum of Patient Care

FOR IMMEDIATE RELEASE…Feb. 26, 2015…Miami…bioTheranostics, Inc., today announced results from a study being presented at the 32nd Miami Breast Cancer Conference that further support the role of its Breast Cancer IndexSM (BCI) molecular test in assessing risk of late recurrence and determining which patients with early stage, estrogen receptor-positive (ER+) breast cancer are likely to benefit from extended endocrine therapy. A workshop discussing use of BCI in clinical practice also will be held during the conference. The study included 750 cases submitted for BCI testing that were analyzed to assess the utilization and clinical utility of the test in routine practice. BCI identified a large portion of patients (39 percent) as having a less than 5 percent risk of late recurrence and low likelihood of benefiting from extended endocrine therapy, patients who may be adequately treated with five years of adjuvant endocrine therapy. The test also identified a population of patients (32 percent) with a higher (greater than 5 percent) risk of recurrence and high likelihood of benefiting from extended endocrine therapy, and who may be more appropriate candidates for longer treatment. Results of this retrospective analysis demonstrate the clinical utility of BCI in stratifying patients and identifying those likely to benefit from extended endocrine therapy, while potentially minimizing unnecessary treatment for those women who are unlikely to benefit from extending endocrine therapy beyond five years post-diagnosis. Nicolas Barthelemy, President and CEO of bioTheranostics, said this review demonstrates the real-world use of BCI along various points from the time of breast cancer diagnosis. Only about half of testing was performed around the five-year hormone treatment anniversary—suggesting utility for managing patient expectations earlier than five years and revisiting previous decisions regarding endocrine therapy for patients well past the five-year anniversary. “These results reinforce the growing body of evidence demonstrating the clinical utility of Breast Cancer Index in providing actionable information that aids in decisions about which ER+ patients should be considered for extended endocrine therapy,” Barthelemy said. “This is important, as endocrine therapy entails increased risk of major safety issues such as endometrial cancer, uterine sarcoma, and bone fracture, and tolerability issues that can negatively impact a patient’s quality of life, as well as costs associated with monitoring and mitigating side effects. As a result, BCI may bring clarity to an individual patient’s breast cancer journey.” The poster, titled “Clinical utilization of Breast Cancer Index (BCI), a gene expression-based assay for prediction of late recurrence and benefit from extended endocrine therapy,” will be presented Feb. 26, 2015, at 7:30 p.m. bioTheranostics also will host a workshop featuring Stephen C. Malamud, M.D., a leading oncologist and breast cancer specialist from Mount Sinai Beth Israel Hospital in New York, on the use of BCI in clinical practice. The workshop, titled “The Endocrine Biomarker: Introducing Breast Cancer Index for Clinical Decision-Making in the Extended Endocrine Setting,” will be held Feb. 28, 2015, from 12:45–2:00 p.m.

About Breast Cancer Index Breast Cancer Index is a molecular, gene expression-based test that is uniquely positioned to identify patients best suited for extended endocrine treatment. BCI is the only validated, commercially available test that provides prognostic risk of late recurrence from 5-10 years postdiagnosis, as well as prediction of extended endocrine benefit. 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. 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 estrogen receptor-positive 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 www.biotheranostics.com or www.AnswersBeyond5.com. Follow BCI on Twitter at @AnswersByond5.