Biotheranostics Presents New Data on the Breast Cancer Index® at the San Antonio Breast Cancer Symposium

SAN DIEGO--(BUSINESS WIRE)-Biotheranostics, Inc.. announced the presentation of new data at the San Antonio Breast Cancer Symposium evaluating the impact of the Breast Cancer Index (BCI) in early stage hormone receptor positive (HR+) breast cancer patients classified as intermediate risk for distant recurrence by previous genomic testing. Results indicate that BCI provided additional resolution to stratify patients at risk for late metastatic recurrence, providing an opportunity for shared decision-making regarding extension of endocrine therapy.

In an analysis of lymph node negative HR+ patients, BCI classified 51.5 percent of patients across the spectrum of intermediate genomic risk scores and patient age as high risk for late (beyond 5 years) distant recurrence, indicating a need to continue anti-estrogen treatment to 10 years. Twenty percent of these patients, irrespective of age, were identified as having a greater than 10 percent risk of disease recurrence before 10 years. These findings are critical for oncologists to individualize patient care as standard management for genomic intermediate-risk patients may not include the addition of chemotherapy. Additionally, BCI identified 38 percent of genomic intermediate-risk patients as having a high likelihood of benefiting from extended endocrine treatment—an attribute specific to the HOXB13/IL17BR (H/I) ratio, a unique component of BCI.

The study, titled “Use of Breast Cancer Index to Analyze Tumor Proliferation and Endocrine Responsiveness in Genomic Intermediate Risk Patients,” was presented Thursday, Dec. 6. Click here to view the abstract.

The recently reported American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Focused Update: Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer endorsed multi-gene tests, like BCI, to aid in decisions regarding extended adjuvant endocrine therapy for patients with early stage HR+ breast cancer.

The current analysis evaluated the potential role of BCI to resolve individualization of treatment for intermediate-risk patients. “We’ve long known that so-called intermediate-risk patients may indeed have significant risk of late distant recurrence,” said V.K. Gadi, MD, PhD, medical oncologist, University of Washington/Fred Hutchinson Cancer Research Center, and an author of the analysis. “With today’s increased focus on de-escalation of systemic therapy, it is critical to accurately identify those patients at real risk of recurrence with tumor biology likely to respond to therapy—those who absolutely need treatment.”

Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics, said, “Breast Cancer Index has consistently demonstrated that it is the strongest assay employing gene expression alone for prognostication of late distant recurrence in lymph node negative patients. Breast Cancer Index can help patients and clinicians approach the difficult decision related to extension of endocrine therapy with confidence by integrating the prognostic and predictive information provided by BCI.”

About Breast Cancer Index^®

Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early stage, ER+ breast cancer. This 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 unnecessary treatment. Breast Cancer Index holds guidelines designation from the American Joint Committee on Cancer for cancer staging based on molecular profile; ASCO, NCCN, European Group on Tumor Markers (EGTM), and St. Gallen to inform the chemotherapy decision; and ASCO and EGTM to inform the extended endocrine treatment dilemma. It is the only validated, commercially available test that predicts risk of overall and late distant recurrence, as well as the likelihood of benefit from extended endocrine therapy. For more information, visit breastcancerindex.com.

About Biotheranostics

Biotheranostics, Inc. operates a CLIA-certified and CAP-accredited diagnostic laboratory in San Diego. Biotheranostics is a leading healthcare provider in the oncology field assisting physicians in the treatment of cancer patients. Its suite of proprietary molecular diagnostic tests provides important information to physicians to tailor treatment to individual patients. The company's Breast Cancer Index^® 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. Learn more at biotheranostics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181207005081/en/