Full Press Release Details
Announces Availability of Abstracts With New Clinical Data From Studies
Cancer Diagnostic in Bladder and Breast Cancer
to be Presented at American Association for Cancer Research 2015 Annual
ALAMEDA, Calif.--(BUSINESS WIRE)--March 20, 2015--BioTime, Inc. (NYSE
MKT:BTX) and its subsidiary OncoCyte Corporation today announced the
online availability of abstracts providing human clinical data
highlighting the potential of PanC-Dx , OncoCyte's class of
non-invasive cancer diagnostics based on OncoCyte's proprietary set of
cancer markers. These markers were discovered by company scientists
through an analysis of broad gene expression patterns in numerous cancer
types. These markers, including COL10A1, are the subject of multiple
pending patent claims filed in numerous countries worldwide and are
owned by OncoCyte. Data included in the abstracts will be presented in
two poster presentations at the American Association for Cancer Research
(AACR) Annual Meeting being held April 18-22, 2015.
"The presentations on PanC-Dx at the AACR 2015
annual meeting will report on the first human clinical data from a key
OncoCyte product development program," said Joseph Wagner, PhD,
OncoCyte's Chief Executive Officer. "We, along with our clinical
investigators, are pleased with the high sensitivity and specificity of PanC-Dx
in diagnosing bladder cancer. The levels of accuracy that we report may
give this new diagnostic the potential for widespread adoption as an
improved method of detecting bladder cancer or its recurrence. We
appreciate the effort of our clinical investigators and distinguished
collaborators at Johns Hopkins University School of Medicine, leaders in
bladder cancer research."
The first abstract describes the clinical data and assay development
progress of OncoCyte's bladder cancer diagnostic test. Data obtained
from a clinical study recently completed in collaboration with
investigators in the Department of Pathology at Johns Hopkins University
School of Medicine, was to assess the performance of OncoCyte's
proprietary diagnostic technology in detecting the most common type of
bladder cancer, urothelial carcinoma (UC). Study investigators collected
90 urine samples from patients undergoing urine cytology for the
diagnosis of either primary or recurrent bladder cancer. An analysis was
performed and a panel of markers that discriminates UC from
non-cancerous conditions was identified. Evaluation of the performance
of this gene panel indicated high levels of sensitivity and specificity
(Receiver Operating Characteristic area under the curve of greater than
0.9). Additional evaluation of this gene panel in the context of a
larger multi-site study is ongoing and results from this expanded
clinical study will be included in the presentation.
The second presentation will provide a summary of the clinical data and
assay development progress of OncoCyte's breast cancer diagnostic test.
Specifically, the abstract describes the potential utility of COL10A1 as
a blood-based biomarker for multiple cancers, including breast cancer.
This study involving over 600 patients is being conducted at Scottsdale
Medical Imaging Laboratories.
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.
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 mammography.
Details for the two poster presentations are as follows:
Presentation Title: Identification of gene-expression biomarkers
in urine pathology specimens for the detection of bladder cancer
Location: Poster Section 23
Date & Time: Sunday, April 19, 2015
at 1:00 PM - 5:00 PM EDT
Presentation Title: Identification of type X collagen as a
pan-cancer serum biomarker
Poster Board Number: Board 18
Time: Monday, April 20, 2015, 8:00 AM - 12:00 PM EDT
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.