SAN DIEGO, Calif., May 2, 2017 – A recent analysis from the newly developed Breast Cancer Index (BCI) Clinical Database for Correlative Studies was presented at the 18th American Society of Breast Surgeons Annual Meeting in Las Vegas, NV. The analysis described BCI clinical utilization for prediction of endocrine benefit in early stage, ER+ breast cancer when ordered by breast surgeons.
The results showed that surgeons ordered BCI to inform the extended endocrine treatment decision across the treatment timeline depending on unique needs of the patient. The assay was most commonly ordered at 4-6 years post-diagnosis (~46%), but was also common in the first year (~18%) and >6 years (~16%) post diagnosis. BCI Prognostic and BCI Predictive, components of the Breast Cancer Index assay, provided additional information beyond traditional clinical and pathologic factors; BCI identified 27% of patients with smaller tumors (T1a or T1b) as having a high risk of metastatic recurrence after year 5 and a high likelihood of benefit from extended endocrine therapy (EET). Conversely, in patients with larger tumors (T2 or T3), BCI identified 29.5% of patients as having a low risk of late metastatic recurrence and a low likelihood of benefit from EET. BCI is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET. BCI results were used to prognosticate risk of late recurrence and predict potential benefit from extended endocrine therapy by treating oncologists or surgeons who prescribe endocrine therapy.
The database is an IRB-approved initiative and contains more than 50 de-identified data points including clinical and pathologic characteristics, patient demographics, and BCI test results. “The BCI Clinical Database for Correlative Studies represents a detailed aggregation of molecular biomarker and clinicopathologic data for women with early stage ER+ breast cancer diagnoses that have utilized BCI.” said Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics. “This BCI Clinical Database is a foundation for interactive research collaboration and hypothesis generation with thought leaders in breast cancer. In addition to providing insights into the integration of BCI into clinical care, as we continue to augment the database—anticipating close to 30,000 cases entered by the end of the year—this robust database will allow us to answer important questions regarding the relationship between molecular-based prediction of benefit from EET and traditional clinical and pathologic factors.”
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.