Full Press Release Details
Subsidiary OncoCyte Corporation and Cornell University Enter License
Agreement to Accelerate Lung Cancer Diagnostic Product Development
to be Tested in Patient Samples Collected by Investigators at
Weill-Cornell Medical Center -
ALAMEDA, Calif.--(BUSINESS WIRE)--May 27, 2014--BioTime, Inc. (NYSE MKT:
BTX) and its subsidiary OncoCyte Corporation today announced that
OncoCyte has entered into a License Agreement with Cornell University
through which Weill Cornell Medical College will provide blood samples
derived from healthy people and lung cancer patients for comparative
analysis using the Company's proprietary PanC-Dx
diagnostic tests. OncoCyte scientists will determine levels of
tumor-associated gene expression in these samples, including assessing
levels of its proprietary PanC-Dx cancer markers.
The results of these analyses, along with the results of the nearly
complete clinical study currently being conducted by OncoCyte's
collaborators at The Wistar Institute, will be combined to produce a
data set from over 700 patients. This data will be used by OncoCyte to
assess the performance of potential cancer markers for the purpose of
developing a multi-marker test for the detection of lung cancer. As part
of the License, OncoCyte retains all rights to develop and market its
proprietary lung cancer diagnostic products.
PanC-Dx is a novel class of noninvasive cancer diagnostics
that are based on a proprietary set of cancer markers characterized, in
part, by broad expression patterns in numerous cancer types. The
performance of the marker panel in determining the presence or the
progression of disease in various categories of patients will determine
the specific nature of the test to be developed and the approval pathway
that OncoCyte will pursue.
Annual screening for lung cancer in certain high-risk patients was
recently recommended by the United States Preventative Services Task
Force (USPSTF), an independent panel of experts in primary care and
prevention that systematically reviews the evidence of effectiveness and
develops recommendations for clinical preventive services. The Task
Force recommended screening using low-dose computed tomography (CT).
Although low-dose CT has demonstrated high sensitivity in detecting
early-stage lung cancer in large clinical studies, it also has a high
false-positive rate of approximately 25%.
"A blood-based test that accurately discriminates between cancer and
benign disease would be of great value. I look forward to working with
OncoCyte in helping to develop such a test," said Nasser Altorki, M.D.,
the Gerald J. Ford-Wayne Isom Research Professor in Cardiothoracic
Surgery and professor of cardiothoracic surgery at Weill Cornell Medical
College. Dr. Altorki serves as the "Provider Scientist" on the
Agreement, oversaw collection of the patient samples to be tested by
OncoCyte, and serves as an informal advisor to OncoCyte in the field of
lung cancer diagnostics.
"The recent recommendation by the United States Preventative Services
Task Force to annually screen high-risk patients for lung cancer using
low-dose CT represents a challenge not only for physicians, but also for
insurance coverage providers that now must cover the cost of testing,"
said Joseph Wagner, PhD, OncoCyte's Chief Executive Officer. "Large
scale screening of this population, estimated to represent at least
three million patients per year, could reduce overall lung cancer
mortality through earlier detection. However, the high number of
false-positive tests could lead to over a billion dollars a year in
unnecessary costs to the United States health care system as a result of
associated follow-up testing. Physicians, payers, and patients would
therefore welcome a simple to use, low-cost, blood-based test that can
help guide patient-management decisions by noninvasively ruling out the
presence of cancer. OncoCyte's licensing agreement with Cornell
University, managed by the Cornell Center for Technology, Enterprise and
Commercialization, along with our existing collaboration with The Wistar
Institute, should help accelerate development of that lung cancer
diagnostic product."
About OncoCyte Corporation
OncoCyte, a majority-owned subsidiary of BioTime, Inc., is developing
novel products for the diagnosis and treatment of cancer in order to
improve the quality and length of life of cancer patients. Based on
large unmet need, market size, and data generated thus far from patient
sample screening, OncoCyte is initially focusing its efforts on
developing PanC-Dx diagnostic products for use in detecting
breast, bladder, and lung cancers. PanC-Dx is a class of
non-invasive cancer diagnostics based on a proprietary set of cancer
markers characterized, in part, by broad gene expression patterns in
numerous cancer types. The PanC-Dx biomarkers were discovered as
a result of ongoing research within OncoCyte and BioTime on the gene
expression patterns associated with embryonic development. This research
has demonstrated that many of the same genes associated with normal
growth during development are abnormally reactivated by cancer cells.
These genes regulate such diverse processes as cell proliferation, cell
migration and blood vessel formation. Many of these genes have not been
previously associated with cancer. Moreover, expression of a large
subset of these genes is conserved across numerous cancer types (e.g.
cancers of the breast, colon, ovaries, etc.), suggesting these genes may
control fundamental processes during cancer growth and progression. In
addition to their potential value in developing diagnostic biomarkers,
an understanding of the pattern of expression of these genes may also
enable the development of powerful new cancer therapeutics that target
rapidly proliferating cancer cells.
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime's focus is on pluripotent stem cell technology based on
human embryonic stem ("hES") cells and induced pluripotent stem ("iPS")
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime's
therapeutic and research products include a wide array of proprietary PureStem
progenitors, HyStem hydrogels, culture media,