Miami Breast Cancer Conference Study & Workshop Reinforce Clinical Utility of Test Along the Continuum of Patient Care

FOR IMMEDIATE RELEASE…Feb. 26, 2015…Miami…Biotheranostics, Inc., today announced results from a study being presented at the 32nd Miami Breast Cancer Conference that further support the role of its Breast Cancer IndexSM (BCI) molecular test in assessing risk of late recurrence and determining which patients with early stage, estrogen receptor-positive (ER+) breast cancer are likely to benefit from extended endocrine therapy. A workshop discussing use of BCI in clinical practice also will be held during the conference.

The study included 750 cases submitted for BCI testing that were analyzed to assess the utilization and clinical utility of the test in routine practice. BCI identified a large portion of patients (39 percent) as having a less than 5 percent risk of late recurrence and low likelihood of benefiting from extended endocrine therapy, patients who may be adequately treated with five years of adjuvant endocrine therapy. The test also identified a population of patients (32 percent) with a higher (greater than 5 percent) risk of recurrence and high likelihood of benefiting from extended endocrine therapy, and who may be more appropriate candidates for longer treatment. Results of this retrospective analysis demonstrate the clinical utility of BCI in stratifying patients and identifying those likely to benefit from extended endocrine therapy, while potentially minimizing unnecessary treatment for those women who are unlikely to benefit from extending endocrine therapy beyond five years post-diagnosis.

Nicolas Barthelemy, President and CEO of Biotheranostics, said this review demonstrates the real-world use of BCI along various points from the time of breast cancer diagnosis. Only about half of testing was performed around the five-year hormone treatment anniversary—suggesting utility for managing patient expectations earlier than five years and revisiting previous decisions regarding endocrine therapy for patients well past the five-year anniversary

“These results reinforce the growing body of evidence demonstrating the clinical utility of Breast Cancer Index in providing actionable information that aids in decisions about which ER+ patients should be considered for extended endocrine therapy,” Barthelemy said. “This is important, as endocrine therapy entails increased risk of major safety issues such as endometrial cancer, uterine sarcoma, and bone fracture, and tolerability issues that can negatively impact a patient’s quality of life, as well as costs associated with monitoring and mitigating side effects. As a result, BCI may bring clarity to an individual patient’s breast cancer journey.”

The poster, titled “Clinical utilization of Breast Cancer Index (BCI), a gene expression-based assay for prediction of late recurrence and benefit from extended endocrine therapy,” will be presented Feb. 26, 2015, at 7:30 p.m.

Biotheranostics also will host a workshop featuring Stephen C. Malamud, M.D., a leading oncologist and breast cancer specialist from Mount Sinai Beth Israel Hospital in New York, on the use of BCI in clinical practice. The workshop, titled “The Endocrine Biomarker: Introducing Breast Cancer Index for Clinical Decision-Making in the Extended Endocrine Setting,” will be held Feb. 28, 2015, from 12:45–2:00 p.m.

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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