FOR IMMEDIATE RELEASE…December 8, 2016…SAN DIEGO… Biotheranostics today announced that new data will be presented demonstrating the role of the Breast Cancer Index (BCI) in identifying which patients with early stage, ER+ breast cancer are most at-risk for disease recurrence and might benefit from extended anti-estrogen therapy. Data include results from three studies advancing the understanding of the value of BCI to provide information related to tumor biology and inform decisions related to patient treatment. These data will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. BCI is developed and marketed by Biotheranostics, Inc., a pioneer in molecular diagnostics for cancer.
"The growing body of evidence supporting Breast Cancer Index is transforming how doctors assess the long-term needs of their patients with ER+ breast cancer," said Tara Sanft, MD, Assistant Professor of Medicine Medical Oncology; Medical Director of Adult Survivorship for the Yale Cancer Center Survivorship Clinic. "This novel technology helps provide needed clarity in creating precise treatment protocols for patients. With BCI, doctors can help identify those patients at highest risk of relapse and likelihood of benefit from treatment and adjust treatment plans accordingly. These data are important for not only the doctor, but also for the patient to help them achieve optimal health."
Key Data Highlights:
In the multi-institutional, Prospective Study of Incorporating Breast Cancer Index as a Tool for Decision-making Regarding Extension of Adjuvant Endocrine Therapy, poster presented by Tara Sanft, MD, Yale Cancer Center, 141 women diagnosed with early-stage ER+ breast cancer, and their physicians completed pre- and post-BCI questionnaires related to treatment preferences and recommendations, comfort of decision making and satisfaction.
Incorporation of BCI results led to treatment decision changes in 30 percent of patients, and significantly improved patient satisfaction with decisions about whether to extend endocrine therapy to 10 years. Following BCI testing, patient satisfaction increased and patients experienced a significant reduction in overall anxiety level. In addition, 81% percent of patients reported that knowing BCI results made them more likely to comply with their extended endocrine therapy regimen.
The poster "Impact of treatment history on prognostic ability of Breast Cancer Index (BCI): subset analysis from a validation study of patients with hormone receptor-positive (HR+) breast cancer with 1-3 positive nodes," presented by Yi Zhang, Ph.D., Biotheranostics, showcased strong performance from a new model integrating tumor size and grade into BCI (BCIN+) for identifying patients with 1-3 positive lymph nodes at significantly low risk for disease recurrence and who may be adequately treated with adjuvant endocrine therapy alone. The validation cohort included 402 ER+, N1 (1-3 positive nodes) with at least five years of follow up and treated with either tamoxifen alone (n=191) or an aromatase inhibitor only or a sequence of tamoxifen and an aromatase inhibitor (n=211). In the analysis, BCIN+ identified a significant proportion of women with N1 disease with a low risk of late recurrence over 15 years of follow up with similar performance in both tamoxifen and aromatase inhibitor-treated patients.
The poster "Correlation of Breast Cancer Index (BCI) risk classification with tumor grade and Ki-67 in a large series of patients with early-stage, ER+ breast cancer" was presented by Hatem Soliman, M.D., Moffitt Cancer Center, Tampa, FL. In this retrospective study, consecutive cases (n=1359) from node-negative early-stage breast cancer patients submitted for clinical testing with BCI were analyzed. BCI restratified 18% and 28% respectively of high grade/high Ki-67 patients as low risk, demonstrating that BCI captures distinct information and provides molecular resolution related to tumor proliferation status compared to tumor grade and Ki-67.
About Breast Cancer IndexSM
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 with data demonstrating prognostic risk of recurrence out to 15 years, as well as prediction of likelihood of benefit from extended endocrine therapy (treatment in years 5-10). 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. For more information, visit breastcancerindex.com.
Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary genomics-based molecular diagnostics that allow treatment to be tailored to individual patients. The company's Breast Cancer IndexSM and CancerTYPE ID® tests address a variety of unmet medical needs in the management of cancer patients, and extensive clinical studies have confirmed the accuracy, clinical validity, clinical utility, and cost-effectiveness of the tests. Biotheranostics operates a CLIA-certified, CAP-accredited diagnostic laboratory in San Diego. Learn more at biotheranostics.com.
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.