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Press Room

October 10, 2017

Newly Published Data Expands Clinical Utility of Breast Cancer IndexSM to Include Early-Stage, ER+ Patients with Node Positive Disease

- Study Demonstrated Stratification of Approximately 20% of Early-Stage, ER+ Patients with 1-3 Positive Lymph Nodes with a Low Risk of Metastatic Recurrence Out to 15 Years

- In this study, Breast Cancer Index was the Most Significant Prognostic Factor for Disease Recurrence in N1 Patients


SAN DIEGO, Calif., October 10, 2017 – Biotheranostics today announced publication in the Clinical Cancer Research journal of a study evaluating performance of a Breast Cancer Index (BCI) that was specifically developed for early-stage, ER+ breast cancer patients with 1-3 positive lymph nodes. These data expand BCI's clinical utility by demonstrating the test predicts the risk of distant recurrence from diagnosis through 15 years for early-stage, ER+ breast cancer patients with node positive disease.

In this study, 18% of early-stage, ER+ breast cancer patients with 1-3 positive lymph nodes that underwent adjuvant endocrine therapy had a 2.1% risk of recurrence after 15 years, underscoring the validity of Breast Cancer Index to assess the risk of the cancer coming back.

Lymph node-positive breast cancer is associated with a higher risk of recurrence than lymph node-negative breast cancer. Many oncologists recommend more aggressive therapeutic regimens including extending anti-estrogen therapy for five additional years after completion of the first five years for these patients. Before these data, validated tools to help individualize this treatment decision for lymph-node positive patients had been lacking.

"These data are important for the nearly 20% of ER+ breast cancer patients that are node-positive with 1-3 positive lymph nodes, and are generally considered to have a high risk of metastatic recurrence," said Dennis Sgroi, MD, Executive Vice-Chair and Director of Breast Pathology, Professor of Pathology, Harvard Medical School and lead investigator for this study. "These data for BCI in node-positive patients means that some of these patients who have already undergone chemotherapy and five years of endocrine therapy, will have a tool to personalize the shared decision with their doctor and to weigh the potential benefits of another five years of endocrine therapy vs. the potential risks."

Study Design and Results
The objective of this blinded study reported in Clinical Cancer Research was to independently evaluate a new BCI algorithm and prognostic model that combines gene expression with tumor size and grade in a large cohort of 402 early-stage, HR+ patients with 1-3 positive nodes. In patients who received tamoxifen or aromatase inhibitor therapy for up to 5 years, BCI classified 18% of patients as overall low risk with a 15-year risk of metastatic recurrence of 2.1% vs a 15 year risk of 36.8% in the remaining patients (classified as the high-risk group). In the subset of patients who were disease free at year five, 22% were classified as low risk (2.1% overall risk of distant recurrence) vs. the remaining patients, who had a risk of distant recurrence of 19%. The study confirms BCI can offer valuable information to both physicians and patients considering extended endocrine treatment and indicates that women with BCI low risk N1 disease might not require an additional five years of endocrine therapy.

Additionally, the BCI test result was the most significant factor for prognosticating overall and late-distance (post 5-yr) recurrence, when compared with age, progesterone receptor status, chemotherapy treatment, duration and type of endocrine treatment, and number of positive lymph nodes.

Don Hardison, president and CEO of Biotheranostics, said the data further demonstrate BCI's potential to improve the personalization of breast cancer treatment. "We are thrilled to see the continued evolution of BCI to help select the right women for extended endocrine therapy,” Hardison said. "These results allow patients like this to have a more individualized discussion with their doctors about their risk of recurrence and recommended treatment after five years of endocrine therapy. Not every node positive patient is at significant risk of disease recurrence or should be treated in the same way."

About Breast Cancer IndexSM

BCI is a molecular, gene expression-based test uniquely positioned to help identify early-stage, ER+ breast cancer 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

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