OncoCyte Reports Successful Completion of Follow on Breast Cancer Diagnostic Study
June 15 2017 - 7:00AM
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive tests for the early detection of
cancer, announced today that it has successfully completed a
follow on study of its breast cancer diagnostic test. The study,
known as NICE-BC (
Non-
Invasive
Confirmatory d
Etection (of)
Breast
Cancer, has confirmed the
findings of OncoCyte’s previous breast cancer study, which was
presented at the San Antonio Breast Cancer Symposium (SABCS) in
December 2016. OncoCyte has submitted an abstract of its NICE-BC
study findings to a major medical conference and if the abstract is
accepted anticipates reporting final results later this year.
OncoCyte’s breast cancer diagnostic is a blood
test being designed as an adjunct to mammography that will help
physicians to avoid unnecessary breast biopsies. The Company
believes that its test can significantly reduce the number of
avoidable biopsies, with substantial savings to the healthcare
system.
“Submission of the abstract is a significant
achievement in the development program of our breast cancer
diagnostic and we look forward to sharing the results later in the
year,” said William Annett, Chief Executive Officer. “As we get
closer to the commercial launch of our lung cancer diagnostic,
progress with our breast cancer diagnostic is gaining
momentum.”
The NICE-BC study used a larger number of
samples from a broader population than the earlier study presented
at SABCS. That earlier study included a report on a 100 sample
novel panel of serum protein biomarkers designed to allow for the
non-invasive and sensitive detection of breast cancer in BI-RADS
category 4 patients. As reported at SABCS, the 15-marker model
resulted in an area under the curve (AUC) of 0.92 with a
sensitivity of 90% and specificity of 76%. Thus, OncoCyte’s novel
panel of serum protein biomarkers may become the foundation of a
highly accurate non-invasive breast cancer diagnostic test.
The AUC of a test is a measure that combines
sensitivity and specificity to express its total accuracy, with 1.0
being perfect accuracy and 0.50 being a random result. Sensitivity
and specificity are statistical measures of test performance, with
sensitivity measuring the percentage of malignant lumps or masses
that are identified correctly by the test and specificity measuring
the percentage of benign lumps or masses correctly identified.
Of the approximately 39 million women in the
United States in 2016 who underwent mammograms, approximately 1.7
million were determined to have suspicious lumps or masses and were
then referred for an invasive follow-on breast biopsy to determine
if the mass was malignant or benign. Only about 20 percent of those
breast biopsies resulted in a cancer diagnosis, with the rest of
the masses being benign. Consequently about 80 percent of the
biopsies were unnecessary and avoidable because the mass was
benign. The annual estimated cost to the healthcare system for
benign biopsies is estimated to be about $2.8 billion.
About Breast Cancer
Breast cancer is the second most common cancer
among U.S. 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” and other cautionary statements 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.
Doug Sherk / Matt Haines
646-445-4800
dsherk@evcgroup.com / mhaines@evcgroup.com
Financial Media Contact:
GIBSON Communications, LLC
Tom Gibson
201-476-0322
tom@tomgibsoncommunications.com