- Findings from correlative studies elucidate association between Breast Cancer IndexSM (BCI) with traditional clinicopathologic and molecular factors


SAN DIEGO, Calif., December 8, 2017 – Biotheranostics releases the results from 6 multi-institutional collaborative studies at the San Antonio Breast Cancer Symposium this week. These studies, led by breast oncology thought leaders, analyze data from the proprietary Breast Cancer Index (BCI) Clinical Correlative Database which represents a detailed aggregation of molecular biomarker and clinicopathologic data for women with early stage estrogen-receptor positive (ER+) breast cancer diagnoses in whom BCI has been utilized to inform the decision to extend or end endocrine therapy after five years of treatment. The database is an IRB-approved, deidentified data repository containing more than 50 data points per patient, including their BCI test results.

The extension of endocrine therapy for women with early stage, ER+ breast cancer has been, and continues to be, one of the most studied questions in oncology. Breast Cancer Index is uniquely qualified and validated to inform this shared decision between patient and physician through its prognostic and predictive test results. The database of nearly 20,000 patients provides an approach to gain powerful insights into the integration of BCI into routine clinical care and addresses important questions regarding the relationships between molecular-based prediction of risk of recurrence, benefit from extended endocrine therapy (EET), and traditional clinical and pathologic factors.

As clinical adoption of Breast Cancer Index continues to grow, the requests from luminaries to help clarify the correlation of independent clinicopathological factors and other molecular tests with the Breast Cancer Index test results have also increased. “What we have routinely found is that although there is moderate correlation between BCI and clinicopathologic factors, BCI identifies a significant subset of patients who, considered low risk based on traditional parameters, are in fact at high genomic risk of late recurrence and high likelihood of benefit from EET. Additionally, there is significant discordance between BCI and other genomic tests for this same measure. Furthermore, neither clinical pathological factors nor other molecular tests predict benefit from extended endocrine therapy,” said Dr. Catherine Schnabel, Chief Scientific Officer, Biotheranostics.

Analyses focusing on known prognostic factors to assess risk and inform the extended endocrine decision including lymphovascular invasion status, nodal status, quantitative hormone receptor expression, proliferation status, age, tumor grade and tumor size, and previous genomic test results will be presented at the Symposium during the week beginning Wednesday through Saturday.

These results provide additional insight into tumor, patient and molecular features and their relation to BCI , and enable characterization of this important tool that provides additional information beyond clinicopathology to help physicians to better personalize EET recommendations -- informing patient selection for extended therapy, while potentially minimizing exposure to unnecessary side effects and toxicities for the patients who are at low risk of late distant recurrence and low likelihood of benefit from EET.

About Breast Cancer IndexSM

BCI is a molecular, gene expression-based test uniquely positioned to help identify patients with early-stage, ER+ breast cancer who may be suitable candidates for extended endocrine treatment. It is the only validated, commercially available test that predicts risk of late distant recurrence, as well as the likelihood of benefit from extended endocrine therapy. The breakthrough test helps oncologists and patients navigate the difficult trade-off between taking 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.

About Biotheranostics

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.


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.

Biotheranostics Page

Biotheranostics, Inc. | 9640 Towne Centre Drive | Suite 200 | San Diego, CA 92121 | Biotheranostics.com

US and International: +1 (858) 587-5870 | Fax: +1 (800) 266-9607 | Client Services: +1 (877) 886-6739 | Billing Information: +1 (888) 286-0755 | Patient Advocates Team: +1 (844) 319-8111

© 2018 Biotheranostics, Inc. Breast Cancer Index and BCI are service marks of Biotheranostics, Inc.