Yale Study Shows bioTheranostics’ Breast Cancer IndexSM Molecular Test Impacts Extended Endocrine Therapy Decisions in Clinical Practice

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

SAN DIEGO–(BUSINESS WIRE)–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
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 over-treatment 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 BCI

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

, 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 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. Its 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. 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.


Sullivan & Associates
Barbara Sullivan, 714-374–6174