Clinical Use of Breast Cancer Index Led to Fewer Recommendations for Treatment & Reduced Patient Anxiety

FOR IMMEDIATE RELEASE…Dec. 7, 2015…SAN DIEGO……In the first prospective assessment of the impact of Biotheranostics’ Breast Cancer IndexSM (BCI) molecular test in clinical practice, incorporation of BCI results led to treatment decision changes in 26 percent of patients, and improved patient satisfaction with decisions about whether to extend endocrine therapy to 10 years. The study, conducted by researchers at Yale Cancer Center, was published online in the journal Breast Cancer Research and Treatment.

In the prospective study of the decision-making impact of BCI, researchers evaluated how BCI testing in patients with estrogen receptor-positive (ER+) breast cancer influenced decisions about extending endocrine therapy to 10 years versus five years. BCI provides both predictive information about likelihood of benefit from extended endocrine therapy and prognostic information about risk of disease recurrence 5-10 years post-diagnosis.

Genomic classification with BCI was performed on archived tumor tissues from 96 patients, and results were reported to treating physicians for discussion with patients. The study included a mix of patients that represented the heterogeneity of ER+ early stage breast cancer: node positive and node negative patients, pre- and post-menopausal patients, tamoxifen and aromatase inhibitor treatment histories, and HER2+ and HER2- subsets. Patients and physicians completed pre- and post-test questionnaires regarding preferences for extended therapy. Patients also completed Decisional Conflict Scale and State Trait Anxiety Inventory forms pre- and post-test.

Following BCI testing, physicians changed their treatment recommendations for 26 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 20 percent fewer patients post-testing. Physicians were three times more confident in their recommendations after the test results than before. Following BCI testing, patient satisfaction increased and patients experienced a significant reduction in overall anxiety level. Sixty-nine percent of patients also reported that knowing BCI results made them more likely to comply with their extended endocrine therapy regimen.

"With trends toward recommending longer durations of therapy, there are financial and emotional costs to patients, many who will not recur,” said Tara Sanft, M.D., assistant professor of Medical Oncology at Yale. “This study showed that the Breast Cancer Index results lead to fewer recommendations for extended treatment, higher confidence levels in physicians, and improved patient satisfaction and comfort. The use of this test has implications to reduce overtreatment while continuing to recommend therapies for those at high risk."

Nicolas Barthelemy, president and CEO of Biotheranostics, said, “Extended endocrine therapy trials have demonstrated improved outcomes in early stage ER+ breast cancer, but the absolute benefit is modest, and toxicity and tolerability are significant issues for physicians and patients. This real-world study demonstrates the value of BCI in influencing these important decisions and adds to the growing body of evidence showing that BCI provides critical information about patient biology that translates into more individualized patient care.”

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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