Study Presented at San Antonio Breast Cancer Symposium Demonstrates Strong Performance of Biotheranostics’ 92-gene Assay in the Diagnosis of Triple Negative Breast Cancer

SAN DIEGO–(BUSINESS WIRE)–A study showing the strong performance of an optimized version of
Biotheranostics’ 92-gene assay to accurately identify both primary and
metastatic triple negative breast cancer was presented Friday, Dec. 9,
at the 2016 San Antonio Breast Cancer Symposium.

Triple negative breast cancers (TNBC) are often poorly differentiated
tumors that may confound the initial pathology workup because TNBC lacks
typical protein markers used to distinguish breast tumors from other
tumor types that can be histomorphologically similar to TNBC. Accurate
and early diagnosis of TNBC is important for individualizing a patient’s
treatment plan, which may include neoadjuvant and/or adjuvant
chemotherapy to treat this aggressive form of breast cancer.

First author Peggy Sullivan, M.D., Associate Professor of Pathology and
Laboratory Medicine at the David Geffen School of Medicine at UCLA,
said, “There is a strong need for a molecular classifier for TNBC
because of its diagnostic difficulty in the setting of metastatic
disease. Given the limited treatment options for TNBC and the associated
poor prognosis, more refined tumor characterization is important for
developing optimal chemotherapy regimens or clinical trial therapies for
patients. As a result, biomarkers that can aid in the diagnosis of TNBC
are essential.”

The study included 160 tumor samples from TNBC (57%) and non-breast
tumors (43%) that were tested in a blinded manner. For performance in
TNBC, the optimized 92-gene assay demonstrated an overall sensitivity of
88% (95% CI, 81-92), and sensitivities of 96% (95% CI, 89-99) and 80%
(95% CI, 52-96), in primary and metastatic tumors, respectively. The
overall sensitivity for non-breast tumors such as gastrointestinal,
gynecological, and lung tumors that can have pathology overlap with TNBC
was 89% (95% CI, 75-96).

“These initial study results are important because triple negative
breast cancer is an aggressive disease for which accurate and timely
diagnosis is critical to treatment selection,” said Nicolas Barthelemy,
President and CEO of Biotheranostics. “With this new algorithm for
triple negative breast cancer developed in collaboration with a team of
pathologists, our goal is to establish a higher level of accuracy, and
these results show we are on the right pathway. We will continue to
leverage our expertise in molecular diagnostics to develop new ways to
help improve the care and outcomes for all cancer patients.”

“Triple negative breast cancer is an aggressive form of breast cancer
with only a few treatment options,” said Elena Brachtel, M.D., Assistant
Professor of Pathology at Harvard Medical School, and Assistant
Pathologist at Massachusetts General Hospital. “These study results show
high sensitivity to identify both primary and metastatic triple negative
breast cancer, which is an important first step in establishing the
clinical utility of molecular cancer classification and its ability to
inform clinical decision making for patients with this challenging

To access the study abstract, titled An Optimized 92-gene Assay for the
Molecular Diagnosis of Triple-Negative Breast Cancer (Poster No.
P5-03-01), click here.

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the
care of cancer patients, offering a suite of proprietary genomics-based
molecular diagnostics that allow treatment to be tailored to individual
patients. The company’s CancerTYPE
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 operates a CLIA-certified,
CAP-accredited diagnostic laboratory in San Diego. Learn more at


Barbara Sullivan, Sullivan & Associates