Full Press Release Details
Clinical Results of OncoCyte's PanC-Dx
Diagnostic Test Demonstrate High Level of Sensitivity and Specificity in
Non-Invasive Detection of Bladder Cancer
Presented at American Association for Cancer Research 2015 Annual Meeting
ALAMEDA, Calif.--(BUSINESS WIRE)--April 20, 2015--BioTime, Inc. (NYSE
MKT:BTX) and its subsidiary OncoCyte Corporation today announced
positive clinical results of PanC-Dx , OncoCyte's class of
proprietary, non-invasive cancer diagnostic tests, in detecting the most
common type of bladder cancer, urothelial carcinoma (UC). Karen B.
Chapman, PhD, Vice President of Research at OncoCyte, presented the
results from two prospective clinical studies of PanC-Dx at
the American Association for Cancer Research (AACR) Annual Meeting
during a poster presentation from 1:00 PM - 5:00 PM EDT on Sunday, April
The first clinical study was conducted by OncoCyte in collaboration with
investigators in the Department of Pathology at Johns Hopkins University
School of Medicine led by Matthew T. Olson, M.D., Assistant Professor
and Associate Director of the Division of Cytopathology in the
Department of Pathology at Johns Hopkins University School of Medicine
and principal investigator of the trial, and Dorothy Rosenthal, M.D.,
Professor of Pathology, Oncology and Gynecology/Obstetrics at Johns
Hopkins University School of Medicine and collaborator on the study.
Clinical investigation involved collection of 90 urine samples from
patients undergoing urine cytology for the diagnosis of either primary
or recurrent bladder cancer. Patient urine samples were assessed
microscopically for the presence of cancer cells using the current
standard-of-care method of cytopathology; in parallel, study
investigators analyzed the urine samples for gene expression. A panel of
43 gene expression biomarkers that distinguishes UC from non-cancerous
conditions was identified.
Study investigators then investigated the performance the 43-marker
panel derived from the first clinical study using a set of 195 urine
samples obtained from a second, large ongoing clinical study at multiple
urology clinics in the United States. Investigators in the trial are
collecting urine samples from patients undergoing cystoscopy for the
diagnosis of either primary or recurrent bladder cancer. A gene
expression classifier was developed with the goal of distinguishing
between UC and benign conditions. Performance of the classifier was
evaluated using several cross-validation criteria, including Receiver
Operating Characteristic (ROC) area under the curve (AUC) analysis,
yielding an AUC of 0.91 (sensitivity of 90% with a specificity of
82.5%). Optimal performance of the classifier was achieved using only
"The encouraging results to date validate our confidence that the PanC-Dx
diagnostic technology can be used to develop a potentially accurate and
more convenient alternative for detecting bladder cancer or its
recurrence, compared to currently used costly and invasive diagnostic
procedures," said Joseph Wagner, PhD, OncoCyte's Chief Executive
Officer. "Our second bladder cancer clinical trial of up to 1,400
patient samples is approximately half-way complete in terms of patient
enrollment and should be completed by the end of 2015. This study will
further refine and validate PanC-Dx , as well as establish
initial clinical utility data. Although further clinical studies may be
necessary for approval by the U.S. Food and Drug Administration, the
data from these two studies could enable us to advance into the
commercialization phase of our bladder cancer diagnostic test."
Overall markets for bladder cancer diagnostics are large and growing.
Based on National Cancer Institute statistics, it was estimated that in
2015 over 74,000 new cases of bladder cancer would occur in the United
States and a total of over 500,000 men and women alive would have a
history of bladder cancer and be subject to recurrence surveillance
testing using cystoscopy or urine cytology. Bladder cancer has the
highest recurrence rate of any major type of cancer; recurrence
surveillance testing is strongly recommended and widely performed.
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 embryonic 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, Inc., a pioneer in regenerative medicine, is a clinical-stage
biotechnology company. BioTime and its subsidiaries are leveraging their
industry-leading experience in pluripotent stem cell technology and a
broad intellectual property portfolio to facilitate the development and
use of cell-based therapies and gene marker-based molecular diagnostics
for major diseases and degenerative conditions for which there presently
are no cures. The lead clinical programs of BioTime and its subsidiaries
include: OpRegen , currently in a Phase I/IIa
trial for the treatment of the dry form of age-related macular
degeneration; AST-OPC1, currently in a Phase I/IIa trial for
spinal cord injuries; Renevia , currently in a pivotal trial in
Europe as an injectable matrix for the engraftment of transplanted cells
to treat HIV-related lipoatrophy; and PanC-Dx cancer