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Press Room

December 8, 2015

Studies Demonstrate Broadening Clinical Utility of bioTheranostics’ Breast Cancer Index Molecular Test in the Extended Endocrine Therapy Setting

Results Presented at San Antonio Breast Cancer Symposium Illustrate BCI’s Contribution to Advancing Clinical Care
FOR IMMEDIATE RELEASE…Dec. 8, 2015…SAN DIEGO…bioTheranostics, a leader in molecular diagnostics for cancer, announced the results of several studies being presented at the San Antonio Breast Cancer Symposium this week, including a key study focused on the development of a new Breast Cancer IndexSM (BCI) prognostic test for women with lymph nodepositive disease, and other studies reinforcing the clinical utility of BCI in predicting risk of recurrence 5–10 years post-diagnosis and likelihood of benefit from extended endocrine therapy.

Nicolas Barthelemy, president and CEO of bioTheranostics, said the studies demonstrate the growing role of BCI in advancing the care of breast cancer patients. “We are excited to disclose the development of a new BCI prognostic model for patients with lymph node positive disease,” Barthelemy said. “We’re also pleased to see additional strong confirmation of the clinical utility of BCI. These results, along with an independent study about the value of BCI in a breast cancer practice, help set BCI apart as the only molecular test that facilitates selection of women likely to benefit from extended endocrine therapy, thus potentially sparing those unlikely to benefit from adverse events and toxicities that can negatively affect their health and quality of life.”

In a study of patients from the landmark TransATAC trial, 219 primary tumor samples from estrogen receptor-positive patients with 1-3 positive lymph nodes treated with five years of endocrine therapy alone were examined. BCI was combined with tumor size and grade into a comprehensive risk score toward the development of a new BCI prognostic test for patients with lymph node positive breast cancer. Results showed that in 55 women categorized as low risk (25 percent), there were no distant recurrences within 10 years, suggesting that these women might not require adjuvant chemotherapy or extended endocrine therapy. The study (abstract No. P2-08-12) is being presented as a poster on December 10th.

Three additional studies that will be presented evaluate the potential symptom burden associated with extended endocrine treatment and provide support for the clinical utility of BCI in routine clinical care, including:

  • A health outcomes study employed a retrospective review of medical records for 308 breast cancer patients to assess the impact of extended endocrine therapy on symptoms Studies Demonstrate Broadening Clinical Utility of bioTheranostics’ Breast Cancer Index and quality of life. The patient-reported results indicated that extended endocrine therapy is associated with continued symptom burden that may negatively impact quality of life, including reduced sexual enjoyment and vaginal dryness. The study (abstract No. P4- 11-03) is being presented as a poster on December 11th.
  • An assessment of patient risk stratification by BCI Predictive versus Oncotype Dx plus quantitative estrogen receptor expression (qER) was completed in a series of 105 cases. BCI Predictive identified a large proportion of Oncotype Dx low and intermediate risk patients as having a high likelihood to benefit from extended endocrine therapy. These results support the concept that the underlying biology of risk stratification (prognosis) differs from that of endocrine responsiveness (predictive). The study (abstract No. P5-08-09) is being presented as a poster on December 11th.
  • An evaluation of 742 patients from the TransATAC trial cohort based on the combined categories of BCI Prognostic and BCI Predictive (H/I). Findings indicate that patients classified as BCI low risk, regardless of H/I status, had sufficiently low recurrence rates and identify patients who may be adequately treated with five years of endocrine therapy. The study (abstract No. P5-08-03) is being presented as a poster on December 11th.

About bioTheranostics bioTheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary molecular diagnostic tests that allow treatment to be tailored to individual patients. The company’s Breast Cancer IndexSM helps oncologists make difficult decisions about extended endocrine therapy for ER+ breast cancer patients. Its CancerTYPE ID® is the most rigorously validated gene expression test for metastatic patients with diagnostic ambiguity, helping physicians determine optimal site-directed treatment regimens with the goal of improving patient outcomes. bioTheranostics, a bioMérieux company, is based in San Diego. For more information, visit or Follow BCI on Twitter at @AnswersByond5.