OncoCyte Presents Positive Data from its Liquid Biopsy Breast Cancer Diagnostic Test at the San Antonio Breast Cancer Sympos...
December 07 2017 - 8:30AM
OncoCyte Corporation (NYSE American:OCX), a developer of novel,
non-invasive liquid biopsy tests for the early detection of
cancer, today presented positive data from its most recent
breast cancer diagnostic test study at the 2017 San Antonio Breast
Cancer Symposium (SABCS). The data were presented by Philip
McQuary, Ph.D., Director of Product Development at OncoCyte.
This study revealed that a novel blood based
diagnostic test may allow for the non-invasive and sensitive
detection of breast cancer in BI-RADS category 4 patients, thereby
differentiating women who have breast cancer from those who do not.
A 19-marker model resulted in an AUC of 0.935 with a sensitivity of
90% and specificity of 82%. The data from this study are consistent
with data reported at the San Antonio Breast Cancer Symposium in
December 2016.
The poster, titled “Assessment of an Immune
Response Panel of Serum Protein Biomarkers for the Non-Invasive
Detection of Breast Cancer,” discusses details of OncoCyte’s study
in which serum samples were collected at four U.S. sites from 136
women with suspicious diagnostic mammography findings undergoing
biopsy to determine if they have breast cancer. All 136 subjects
had mammograms and were classified as BI-RADS category 4 and had
pathology confirmation of their diagnosis (malignant or benign).
Statistical screening methodologies were used to identify markers
with the potential to distinguish benign from malignant pathology.
The candidate markers were further studied and combined to develop
a potential diagnostic test.
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. A BI-RADS category 4 classification indicates
a suspicious result, and women in this category are generally
referred for a breast biopsy. 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 lesions that are identified correctly by the test and
specificity measuring the percentage of benign lumps or masses
correctly identified.
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 potentially would reduce the number of patients subjected
to invasive breast biopsy procedures. Further R&D and clinical
utility studies are required to determine whether the confirmatory
test would be accurate and commercially viable.
According to published reports, there are about
38 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
OncoCyte (AMEX:OCX)
Historical Stock Chart
From Mar 2024 to Apr 2024
OncoCyte (AMEX:OCX)
Historical Stock Chart
From Apr 2023 to Apr 2024