Study Demonstrates Approximately 20% of Early‑Stage, ER+ Patients with 1‑3 Positive Lymph Nodes have Low Risk of Metastatic Recurrence Out to 15 Years

FOR IMMEDIATE RELEASE…June 6, 2016…SAN DIEGO…Biotheranostics today announced new independent data validating a new Breast Cancer Index (BCI) prognostic model specifically developed for ER+ breast cancer patients with 1‑3 positive lymph nodes; results to be shown at a poster presentation at the 52 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 3 ‑7. Data solidify BCI's clinical utility by demonstrating the test can now predict the risk of distant recurrence from diagnosis through 15 years for early‑stage, ER+ breast cancer patients with 1‑3 positive nodes. The prognostic component of BCI was previously only validated for node‑negative patients.

In an independent validation study, 20% of early‑stage, ER+ breast cancer patients with 1‑3 positive lymph nodes had a <1.5% 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.1 As a result, many oncologists recommend more aggressive therapeutic regimens for these patients such as extending anti‑estrogen therapy for five additional years after completion of the first five years. Unfortunately, validated tools to help individualize this treatment decision have 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 recurrence," said Lee Schwartzberg, MD, Chief, Division of Hematology & Oncology, University of Tennessee Health Science Center. "The validation of BCI for node‑positive patients means that some of these patients who have already undergone chemotherapy and five years of endocrine therapy, will have a tool that will allow them to work with their doctor to weigh the potential benefits of extended endocrine therapy vs. the potential risks."

Study Design

Previously, in a study of 209 ER+ patients with 1‑3 positive lymph nodes from the landmark TransATAC trial, the BCI algorithm was optimized by incorporating tumor size and grade to develop a new BCI prognostic model specifically for patients with lymph node‑positive breast cancer.

The objective of this new blinded study, being presented at ASCO, was to independently validate the new BCI algorithm and prognostic model in a large cohort of 402 HR+ patients with 1‑3 positive nodes. BCI classified 20% of patients as low risk with a 15‑year risk of metastatic recurrence of <1.5% indicating these women might not require additional endocrine therapy. The study confirmed BCI can offer valuable prognostic information to patients considering extended endocrine treatment. The study (abstract No. 541) is being presented as a poster on June 5.

Nicolas Barthelemy, 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 evolution of BCI to now include a prognostic model for breast cancer patients with 1‑3 positive lymph nodes," Barthelemy said. "The results allow these patients to have a more substantial discussion with their doctors about their risk of recurrence and recommended treatment after five years of endocrine therapy."

About Breast Cancer IndexSM

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 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 www.breastcancerindex.com.

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 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. Its Breast Cancer IndexSM helps oncologists make difficult decisions about extended endocrine therapy for ER+ breast cancer patients based on its unique ability to predict risk of late disease recurrence and identify which patients are likely to benefit from continuing therapy beyond five years. Biotheranostics is based in San Diego. For more information, visit www.biotheranostics.com.

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.

Biotheranostics Page

Biotheranostics, Inc. | 9640 Towne Centre Drive | Suite 200 | San Diego, CA 92121 | Biotheranostics.com

US and International: +1 (858) 587-5870 | Fax: +1 (800) 266-9607 | Client Services: +1 (877) 886-6739 | Billing Information: +1 (888) 286-0755 | Patient Advocates Team: +1 (844) 319-8111

© 2018 Biotheranostics, Inc. Breast Cancer Index and BCI are service marks of Biotheranostics, Inc.