OncoCyte to Present Data from its Liquid Biopsy Breast Cancer Diagnostic Test at the San Antonio Breast Cancer Symposium
December 01 2017 - 7:00AM
OncoCyte Corporation (NYSE American:OCX), a developer of novel,
non-invasive liquid biopsy tests for the early detection of cancer,
will present data from its most recent breast cancer diagnostic
study during a poster session at the 2017 San Antonio Breast Cancer
Symposium (SABCS) on December 7, 2017. The SABCS will take place at
the Henry B. Gonzalez Convention Center in San Antonio, Texas, from
December 5-9, 2017.
The data to be presented are from the Company’s
NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer
follow-on study. The data confirm the findings from OncoCyte’s
previous breast cancer study, which were presented at the San
Antonio Breast Cancer Symposium (SABCS) in December 2016. In the
earlier study, the 15-marker model resulted in an area under the
curve (AUC) of 0.92 with a sensitivity of 90% and specificity of
76%. Given this level of accuracy, and subject to successful
completion of further R&D and clinical studies, 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.
“We look forward to reporting data from our
breast cancer diagnostic development program at this prestigious
conference,” said William Annett, President and Chief Executive
Officer. “The data from our breast cancer studies are compelling
and we look forward to continuing to advance the development
program in 2018. We believe our test would address a significant
unmet need by reducing the number of unnecessary invasive breast
biopsies and lowering the financial burden to the healthcare
system.”
The data from the NICE-BC study will be
presented at SABCS 2017 by Philip McQuary, Ph.D., Director, Product
Development, at OncoCyte.
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Abstract Title: Assessment of an immune response
panel of serum protein biomarkers for the non-invasive detection of
breast cancer |
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Poster Session: 2 (P2-02-03) |
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Session Title: Detection/Diagnosis: Circulating
Markers |
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Session Date: December 7, 2017 |
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Session Time: 7:00 am CT – 9:00 am CT |
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The current standard of care for breast cancer
diagnosis – annual or biannual mammogram screenings – does not meet
the needs of large populations of women for whom mammography alone
is not sufficient. These populations include women with dense
breast tissue, genetic mutations (BRCA), a family history of breast
cancer, or those who have suspicious mammogram screening results
(BIRADs 3 or 4). The Company’s non-invasive liquid biopsy breast
cancer diagnostic is intended to be a confirmatory, post-mammogram
test that would address the needs of some of these populations,
thereby reducing the number of patients subjected to invasive
procedures.
According to published reports, there are about
39 million mammograms performed annually in the U.S., resulting in
1.6 million breast biopsies per year. Of these, only 260,000 (16%)
result in a cancer diagnosis. The large number of suspicious
findings in diagnostic mammograms leads to a significant amount of
unnecessary invasive follow-up procedures. The financial burden to
the healthcare system imposed by the follow-up testing of
false-positive mammograms and breast cancer over-diagnosis is
estimated to be $4 billion a 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 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 detecting lung, breast and bladder
cancer. OncoCyte’s diagnostic tests are being developed using
proprietary sets of genetic and protein markers that differentially
express in specific types of cancer.
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” and similar expressions) are forward-looking
statements. These statements include those pertaining to the
implementation and results of research, development, clinical
trials and studies, commercialization plans, future financial
and/or operating results, and future 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 capacity of our third-party supplied blood sample
analytic system to provide consistent and precise analytic results
on a commercial scale, the need and ability to obtain future
capital, and 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 accordingly as such statements should be evaluated
together with the many uncertainties that affect the business of
OncoCyte, particularly those mentioned in the “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
required by law.
Investor Contacts:
EVC Group, Inc.Matt Haines / Michael Polyviou917-733-9297 /
212-850-5600mhaines@evcgroup.com / mpolyviou@evcgroup.com
Financial Media Contact:
GIBSON Communications, LLCTom
Gibson201-476-0322tom@tomgibsoncommunications.com
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