Full Press Release Details
to Present Cancer Diagnostic Clinical Study Data at AACR Annual Meeting
subsidiary's data collected from prospective clinical studies in bladder
ALAMEDA, Calif.--(BUSINESS WIRE)--February 6, 2015--BioTime, Inc. (NYSE
MKT:BTX) and its subsidiary OncoCyte Corporation today announced that
two abstracts, summarizing clinical studies of OncoCyte's PanC-Dx
diagnostic products for bladder and breast cancer, have been accepted
for poster presentation at the American Association for Cancer Research
(AACR) Annual Meeting being held April 18-22, 2015 in Philadelphia. PanC-Dx
is a class of non-invasive cancer diagnostics based on OncoCyte's
proprietary set of cancer markers, which were discovered by company
scientists through an analysis of broad gene expression patterns in
numerous cancer types. These markers are the subject of multiple pending
patent claims filed in numerous countries worldwide and are owned by
"Solid diagnostic test performance data derived from large prospective
clinical studies is crucial for adoption of novel diagnostic tests by
clinicians and payers," said Joseph Wagner, PhD, OncoCyte's Chief
Executive Officer. "We are excited by the opportunity to present data
from clinical trials of the bladder and breast cancer diagnostics that
we are developing. These tests are designed to be accurate and less
invasive methods to detect and monitor the presence of cancer as
compared to current cancer diagnostic procedures."
"The PanC-Dx clinical data presentations at the upcoming
AACR Annual Meeting are the first of multiple, significant milestones
that BioTime and its subsidiaries expect to achieve in 2015. These
presentations of clinical data reflect our steady progress toward
commercializing cancer diagnostic products aimed at addressing large and
growing markets," said Dr. Michael D. West, Ph.D., BioTime's Chief
The first presentation will provide a summary of the clinical data and
assay development progress of OncoCyte's bladder cancer diagnostic test.
Data obtained from two prospective clinical studies will be presented.
The goal of the first study, recently completed at a leading medical
institution with an international reputation for excellence and
discovery, was to assess the performance of OncoCyte's proprietary
diagnostic technology in detecting the most common type of bladder
cancer, urothelial carcinoma (UC) (previously designated transitional
cell carcinoma). Study investigators collected approximately 100 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, OncoCyte
scientists analyzed the remaining portion of the urine samples for gene
expression, including expression of OncoCyte's proprietary PanC-Dx
markers. A statistical analysis was performed and a panel of markers
that discriminates UC from non-cancerous conditions was identified.
The goal of the second bladder cancer clinical trial, which will involve
up to 1,400 patient samples obtained from at least four and as many as
nine large urology clinics located throughout the United States, is to
compare the performance the marker panel derived from the first clinical
study to the performance of cystoscopy. Investigators in the trial are
collecting urine samples from patients undergoing cystoscopy for the
diagnosis of either primary or recurrent bladder cancer. Cystoscopy and
biopsy results will be compared to the performance of OncoCyte's
proprietary diagnostic test panel. Thus far over 450 patients have been
enrolled in this study; enrollment should be completed in 2015.
Overall markets for bladder cancer diagnostics are large and growing.
Based on National Cancer Institute statistics released in 2012, it was
estimated that in 2013 over 72,000 new cases of bladder cancer would
occur in the United States and a total of over 550,000 men and women
alive would have a history of bladder cancer and be subject to
recurrence surveillance testing using cystoscopy or urine cytology.
The second presentation will provide a summary of the clinical data and
assay development progress of OncoCyte's breast cancer diagnostic test.
Data obtained from a large, prospective clinical study involving 600
patients being conducted at Scottsdale Medical Imaging Laboratories will
be presented. The goal of this study which has nearly completed
enrollment, is to assess the performance of OncoCyte's proprietary
diagnostic technology in discriminating patients with malignant breast
lesions from those with negative or benign findings. Study investigators
are collecting blood samples from patients undergoing screening or
diagnostic mammography. Patient blood samples are being assessed for
expression of OncoCyte's PanC-Dx markers using proprietary
assays and the results compared to radiological and pathology findings.
Mammography has been widely used since the 1970s for breast cancer
screening in asymptomatic women; in 2010 over 30 million screening
mammograms were performed in the US alone. The American Cancer Society
and the National Comprehensive Cancer Network both recommend screening
mammography every year starting at age 40, which has been associated
with relative reduction in breast cancer mortality of 15% to 20%.
However, the NCI estimates that approximately 20% of all breast cancers
are not detected by mammography during annual screening which indicates
there is an unmet need for a breast-cancer screening test with superior
specificity and sensitivity when compared to standard screening
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,