OncoCyte Announces Publication of Breast Cancer Diagnostic Test Abstract; Poster to be Presented at the San Antonio Breast Ca...
14 November 2016 - 9:01PM
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive tests for the early detection of cancer, provided
a summary of the data from its breast cancer diagnostic test that
will be presented at the 2016 San Antonio Breast Cancer Symposium
(SABCS) in December. The data will be presented by Karen B.
Chapman, Ph.D., OncoCyte’s Vice President of Research, at 5:00pm CT
on Friday, December 9th.
The poster titled Development of a panel of
serum-based protein biomarkers for the non-invasive detection of
breast cancer in BI-RADS category 4 patients discusses details of
OncoCyte’s study, which collected serum samples from 100 women with
suspicious diagnostic mammogram findings (primarily BI-RADS
category 4) undergoing biopsy.
The study evaluated the samples on the SOMAscan
Assay 1.3k, which measures 1,310 different proteins. Statistical
screening methods were used to identify markers distinguishing
benign from malignant samples and combine them into a
multi-biomarker algorithm.
This study revealed a novel panel of serum
protein biomarkers that may allow for the non-invasive and
sensitive detection of breast cancer in BI-RADS category 4
patients. A 15-marker model resulted in an AUC of 0.92 with a
sensitivity of 90% and specificity of 76%. The Company is
conducting a follow on multicenter study to further develop and
verify these results in a larger set of prospectively collected
patient samples.
BI-RADS (Breast Imaging and Reporting Data
System) is a scoring system developed by the American College of
Radiologists to help clinicians assess the risk of cancer in women
with a lump or mass. BI-RADS 4 is the score given to a woman
with a suspicious lump or mass.
Each year approximately 38 million women in the
U.S. undergo mammogram screenings. Mammograms detect suspicious
lumps or masses in about 1.5 to 2 million of these women, who then
require an invasive follow-on breast tissue biopsy to determine if
the mass is malignant or benign. However, only about 20% of these
biopsies result in a cancer diagnosis. Consequently, the majority
of biopsies are not needed, and result in unnecessary pain,
discomfort and anxiety to women as well as an estimated $2.8
billion annual cost to the healthcare system.
OncoCyte is focused on developing a confirmatory
diagnostic blood test that can be used as an adjunct to suspicious
mammography results.
“Our goal is to reduce the number of unnecessary
breast biopsies that women have to undergo,” commented William
Annett, President and Chief Executive Officer. “The data from
this initial study is encouraging, and our diagnostic test was able
to distinguish between benign and cancerous masses. To validate
these findings we are now in the process of conducting a larger
study. If successful, our test will address a patient
population of approximately two million American women who have to
have breast biopsies each year.”
About Breast Cancer
Breast cancer is the second most common cancer
among US women. Current screening guidelines set forth by the
American Cancer Society recommend screening mammography for the
early detection of breast cancer in women at average risk.
Specifically, guidelines call for annual mammography for
asymptomatic women age 45 to 54 and once every two years for women
age 55 and older. Suspicious screening mammograms are generally
followed up with a diagnostic mammogram and sometimes by an MRI
(Magnetic Resonance Image) or an ultrasound. Ultimately,
suspicious findings unresolved by imaging typically result in the
recommendation of a breast biopsy.
About OncoCyte Corporation
OncoCyte is primarily focused on the development
and commercialization of novel, non-invasive blood and urine
(“liquid biopsy”) diagnostic tests for the early detection of
cancer to improve health outcomes through earlier diagnoses, to
reduce the cost of care through the avoidance of more costly
diagnostic procedures, including invasive biopsy and cystoscopic
procedures, and to improve the quality of life for cancer
patients.
While current biopsy tests use invasive surgical
procedures to provide tissue samples in order to determine if a
tumor is benign or malignant, OncoCyte is developing a next
generation of diagnostic tests that will be based on liquid
biopsies using blood or urine samples. OncoCyte’s pipeline products
are intended to be confirmatory diagnostics for lung, bladder and
breast cancer. OncoCyte’s diagnostic tests are being developed
using proprietary sets of genetic and protein biomarkers that are
differentially expressed in specific types of cancer.
Forward Looking Statements
This press release contains forward-looking
statements. Any statements that are not historical fact
(including, but not limited to statements that contain words such
as “will,” “believes,” “plans,” “anticipates,” “expects,”
“estimates”) are forward-looking statements. These statements
include those pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for OncoCyte, along with
other statements about the future expectations, beliefs, goals,
plans, or prospects expressed by management. Forward-looking
statements involve risks and uncertainties, including, without
limitation, risks inherent in the development and/or
commercialization of potential diagnostic tests or products,
uncertainty in the results of clinical trials or regulatory
approvals, the need and ability to obtain future capital,
maintenance of intellectual property rights, and the need to obtain
third party reimbursement for patients’ use of any diagnostic tests
we commercialize. Actual results may differ materially from the
results anticipated in these forward-looking statements and as such
should be evaluated together with the many uncertainties that
affect the business of OncoCyte, particularly those mentioned in
“Risk Factors” found in OncoCyte’s Securities and Exchange
Commission filings. OncoCyte disclaims any intent or obligation to
update these forward-looking statements, except as may be required
by law.
Investor Contact:
EVC Group, Inc.
Michael Polyviou/Doug Sherk
646-445-4800
mpolyviou@evcgroup.com / dsherk@evcgroup.com