OncoCyte and The Wistar Institute Present Lung Cancer Diagnostic Data at the CHEST 2016 Annual Meeting
October 17 2016 - 5:00AM
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive blood-based tests for the early detection of cancer,
and The Wistar Institute, an international biomedical research
leader in cancer, immunology and infectious diseases, announced a
summary of the data that will be presented at the American College
of Chest Physician’s CHEST 2016 Annual Meeting, which will be held
October 22-26 in Los Angeles. The data will be presented by lead
investigator Louise Showe, Ph.D., professor in the Molecular and
Cellular Oncogenesis Program and associate director for the Center
for Systems and Computational Biology at The Wistar Institute.
The study demonstrates the ability of a lung
cancer diagnostic to distinguish malignant from benign lung growths
based on previously identified gene expression signatures,
co-developed by Wistar and OncoCyte, under a license from
Wistar. The study, A
Blood Based Non-Small Cell Lung Cancer Diagnostic, was
conducted at Wistar and analyzed 610 human blood samples based on
nodule sizes from 3 mm to 42 mm that were derived from six
collection sites. The data suggest that it is possible to
distinguish malignant from benign lung growths based on the gene
expression signature, and that the classifier can also provide a
preliminary stratification of patients by nodule size and thus
cancer risk. This non-invasive test can potentially differentiate
between those patients with benign nodules and those in need of
further testing by follow up Low Dose Computed Tomography (LDCT),
bronchoscopy or biopsy.
Using all 610 samples, without accounting for
nodule size, the biomarker study derived a sensitivity of 90% and
specificity of 46%. However, specificity changed as a function of
nodule size, with smaller nodules having higher specificity;
consequently, using only nodules less than 10 mm in size (median
6mm), sensitivity was 90% and specificity 54%.
In addition, including nodule size in the
classifier algorithm increased the diagnostic test’s accuracy
significantly. Using both biomarker and nodule size data for all
samples gave sensitivity of 90% and specificity of 80.7%.
“I look forward to presenting our latest data at
CHEST as we are on the cusp of creating a lung cancer diagnostic
for the early detection of lung cancer,” said Showe. “The
partnership with OncoCyte has been critical to moving our research
forward and demonstrates the limitless potential in scientific
collaboration.”
“CHEST is a prestigious event, and it represents
a perfect forum for The Wistar Institute to present this important
data about its latest study on the lung cancer diagnostic,”
commented William Annett, Chief Executive Officer of OncoCyte. “We
are taking the project to the next phase by carrying out our own
study based on Wistar’s encouraging findings and expect to complete
our study later this year. Wistar’s finding that nodule size data
combined with biomarker results significantly increases the
accuracy of the diagnostic test is an important development, and we
will be evaluating nodule size and the test's performance in our
study and algorithm.”
OncoCyte expects that its study results will be
available during the fourth quarter of 2016. If the study is
successful, OncoCyte plans to apply to the State of California for
CLIA certification of its laboratory in the first quarter of 2017
and then conduct a smaller CLIA lab study of the diagnostic test to
ensure that the findings are replicated in an operational setting.
Assuming successful CLIA certification and replication, OncoCyte
plans to launch its lung cancer diagnostic test in the second
quarter of 2017.
About Lung Cancer Lung cancer
is the leading cancer killer of both men and women in the United
States. Lung cancer is the leading cause of cancer deaths
worldwide, accounting for 1.8 million new cases and 1.6 million
deaths annually. An estimated 159,040 Americans will die from lung
cancer in 2015, accounting for approximately 27 percent of all
cancer deaths. It also has one of the lowest five-year survival
rates of all cancer types. The National Institutes of Health
estimates that lung cancer care cost the U.S. $13.1 billion in
2014.
About OncoCyte CorporationOncoCyte 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 detecting lung,
bladder and breast cancer. OncoCyte’s diagnostic tests are being
developed using proprietary sets of genetic and protein markers
that differentially express in specific types of cancer.
About The Wistar InstituteThe
Wistar Institute is an international leader in biomedical research
with special expertise in cancer, immunology, infectious diseases,
and vaccine development. Founded in 1892 as the first independent
nonprofit biomedical research institute in the United States,
Wistar has held the prestigious National Cancer Institute Cancer
Center designation since 1972. The Institute works actively to
ensure that research advances move from the laboratory to the
clinic as quickly as possible. Wistar’s Business Development team
is dedicated to advancing Wistar Science and Technology Development
through creative partnerships. wistar.org
Forward Looking StatementsAny
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) should also be considered to be forward-looking
statements. These statements include those pertaining to the
implementation and results of our validation study and other
studies, commercialization plans, 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, and
maintenance of intellectual property rights, and the need to obtain
third party reimbursement for patient’s 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
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 Contact:
EVC Group, Inc.
Michael Polyviou
646-445-4800
mpolyviou@evcgroup.com