Ability to Predict Benefit from Extended Endocrine Therapy Impacts Treatment & Reduces Patient Anxiety

FOR IMMEDIATE RELEASE…May 30, 2015…Chicago…Biotheranostics, Inc., today announced results from studies being presented at the 2015 American Society of Clinical Oncology (ASCO) meeting reinforcing the role its Breast Cancer IndexSM (BCI) molecular test plays in informing decisions about extending endocrine therapy beyond five years postdiagnosis for patients with early stage, estrogen receptor-positive (ER+) breast cancer. The meeting runs May 29–June 2, 2015, in Chicago.

In the first prospective trial investigating the impact of BCI in clinical practice, BCI results led to changes in treatment decisions in 27 percent of patients tested, and significantly reduced patient anxiety regarding decisions about whether to extend endocrine therapy to 10 years. Other studies further clarify the role of BCI in informing treatment decisions in clinically relevant subsets of patients (e.g., HER2 positive patients) and at various time points along patients’ breast cancer journeys. In addition, new predictive data from the TransATAC randomized trial cohort build on the test’s predictive ability with tamoxifen shown in an adjuvant setting (Stockholm randomized trial cohort), and aromatase inhibitors in the extended endocrine treatment setting (MA-17 randomized trial cohort).

Nicolas Barthelemy, president and CEO of Biotheranostics, said these milestone studies demonstrate how the prognostic and predictive powers of BCI influence important decisions about duration of endocrine treatment. “BCI is a unique predictive indicator of endocrine therapy benefit with growing evidence of utility across both the adjuvant and extended settings. It also has been shown to identify a higher risk of recurrence and an increased likelihood of benefit from extended endocrine therapy in some patients who would be considered low risk using traditional tools. Taken together, these studies continue to show that BCI provides critical information about patient biology that translates into more individualized treatment recommendations and improved patient care.”

Yale Study Reveals Impact of BCI on Extended Endocrine Treatment Decisions

In a prospective study of the decision-making impact of BCI led by Yale University Smilow Cancer Hospital, researchers evaluated how BCI testing in patients with early stage ER+ breast cancer impacted the decision of whether to extend endocrine therapy to 10 years versus five years. Integration of BCI led to change in treatment recommendations for 27 percent of patients, with a majority of changes based on identification of patients with low risk of late recurrence and low likelihood of benefit from extended endocrine therapy. Extended therapy was recommended for 75 percent of patients pre-testing and 55 percent post-testing. The study also demonstrated that patient satisfaction increased and patients experienced significantly less anxiety and conflict with treatment decisions when BCI testing was incorporated. The study (abstract No. 538) is being presented as a poster May 30.

BCI Predicted Benefit of Anastrozole Versus Tamoxifen

In a retrospective study of patients from the prospective, randomized TransATAC trial, BCI Predictive was compared with quantitative estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) expression in assessing the ability to predict benefit from anastrozole versus tamoxifen in 742 patients treated with five years of adjuvant endocrine therapy. Only BCI predicted differential benefit of anastrozole versus tamoxifen. These results support the test’s generalizability as a biomarker of benefit from endocrine therapies. The study (abstract No. 526) is being presented as a poster May 30.

Clinical Utility of Breast Cancer Index in Clinical Practice

A large retrospective analysis in collaboration with Beth Israel Medical Center showed the clinical utility of BCI to stratify patients based on risk of late recurrence and likelihood of benefit from extended endocrine therapy. Results showed that there was pronounced use of the test approaching the five-year anniversary, but also substantial use both earlier and later than the anniversary. In this large, real-world study, BCI identified a majority of patients as having a low likelihood of benefit from extended endocrine therapy. Notably, however, in the subset of patients who would be considered low risk by clinicopathologic criteria and who may have been less likely to be recommended extended endocrine therapy, BCI identified a substantial number as having a higher risk of recurrence and high likelihood of benefitting from extended therapy. The study (abstract No. 545) is being presented as a poster May 30.

Predicting Benefit from Extended Endocrine Therapy in HER2+/HR+ Patients

A study done in conjunction with the University of Wisconsin School of Medicine investigated BCI results in patients with HER2+ versus HER2- early stage breast cancer. BCI classified a higher proportion of HER2+ patients as having high risk for late recurrence and a high likelihood of benefit from extended endocrine therapy compared with HER2- patients. This indicates that a higher proportion of HER2+ patients could be offered extended endocrine treatment. The study ( abstract No. 595) is being presented as a poster May 30.

About Breast Cancer Index

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 that provides prognostic risk of late recurrence (5-10 years post-diagnosis), as well as prediction of likelihood of benefit from extended endocrine therapy. 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. BCI was granted Medicare coverage in October 2014.

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 www.biotheranostics.com or www.AnswersBeyond5.com. Follow BCI on Twitter at @AnswersByond5.

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.

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