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Biotech / Medical : Geron Corp.
GERN 2.9300.0%Feb 7 9:30 AM EST

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From: Savant2/1/2013 1:53:02 AM
   of 3570
 
RT...BioTime's Subsidiary OncoCyte Corporation Provides an Update on the Development
of the Novel Pan-Cancer Diagnostic Product PanC-Dx(TM)

Multi-center clinical study of a blood-based diagnostic test for the early
detection of cancer planned for 2013

ALAMEDA, Calif., Jan 31, 2013 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) and
BioTime's subsidiary OncoCyte Corporation provided an update on the progress of
development of PanC-Dx(TM), a novel blood-based diagnostic test utilizing
molecular markers discovered at BioTime and OncoCyte designed to detect the
presence of various human cancers, including cancers of the breast, lung,
bladder, uterus, stomach, and colon. By facilitating early, non-invasive cancer
detection, PanC-Dx(TM) could lead to more successful therapeutic outcomes through
earlier diagnosis and treatment. This diagnostic test could also reduce the cost
of cancer monitoring and increase the availability of affordable cancer screening
worldwide. OncoCyte first announced the development of PanC-Dx(TM) during
December 2011 and last provided a progress update in March 2012. In addition to
this update, OncoCyte intends to release additional information regarding the
progress of PanC-Dx(TM) development throughout 2013.

OncoCyte's plans for 2013 include the initiation of a clinical study focused on
breast cancer screening at a group of leading cancer research institutions.
OncoCyte has been developing, characterizing, and manufacturing monoclonal
antibodies in preparation for the initiation of the clinical study and is
currently working with a select group of cancer researchers to design the trial
and select the study sites. If its laboratory findings are validated in clinical
trials, PanC-Dx(TM) may be used as a simple, routine blood test that could be
performed in women of any age at any desired frequency to detect breast cancer
with as much if not better accuracy and with less cost than a conventional
mammogram.

OncoCyte has achieved several key advances in the past year, including:

-- Completion of the development and characterization of over 50 proprietary,
patent pending, monoclonal antibodies targeting 7 novel cancer antigens.
OncoCyte's findings show a significant elevation of these antigens in the blood
of cancer patients when compared to healthy control patients;

-- Initiation of validation studies of ELISA assays in order to demonstrate
high-sensitivity detection of target antigens using proprietary monoclonal
antibodies;

-- Completion of large-scale manufacturing of 11 proprietary monoclonal
antibodies;

-- Initiation of prototype development for a second detection format (solid phase
ELISA point of care testing) through a collaborative development agreement; and

-- Initiation of clinical trial protocol design analysis in consultation with key
opinion leaders and outside diagnostic experts.

Key goals for 2013 will be:

-- Completion of validation of our proprietary ELISAs in our patient sample
dataset;

-- Formalization of additional relationships with key opinion leaders at major
medical institutions;

-- Institutional review board (IRB) approval and initiation of a large,
prospective multicenter patient study at leading breast cancer institutions;

-- Presentation of key findings at major oncology-related scientific conferences;
and

-- Submission of manuscripts to peer-reviewed scientific journals for
publication.

Based on large unmet need, market size, and data generated thus far from patient
sera screening, OncoCyte is initially focusing its efforts on biomarkers
associated with breast cancer. The apparent high correlation of certain
combinations of biomarkers in breast cancer has made this indication an
attractive initial target. If clinical trials are successful, OncoCyte intends to
launch PanC-Dx(TM) as an in vitro diagnostic (IVD) in Europe, potentially
commencing in 2014, before seeking FDA approval required to market PanC-Dx(TM) in
the United States. Some CLIA-certified clinical laboratories may choose to offer
PanC-Dx(TM) on a limited basis prior to EU and FDA approval.

"OncoCyte has made substantial progress in the development of PanC-Dx(TM) since
our last update in March of 2012," said Joseph Wagner, Ph.D., CEO of OncoCyte.
"Most importantly, we have developed and characterized a large repertoire of
proprietary monoclonal antibodies to a set of breast cancer-related protein
markers that we have identified and validated over the last few years. OncoCyte
has filed patent applications on these novel, unique markers that we believe are
early indicators of the presence of breast cancer. We have manufactured
substantial quantities of a subset of these proprietary antibodies that show the
greatest promise and we are currently assembling ELISA-format assays. Once we
have completed the validation of these assays and our clinical trial design work,
we intend on initiating a large, multicenter clinical trial later this year."

"There is a great need for rapidly deployed, effective screens to identify a wide
array of human cancers at their earliest stages. A blood-based test with superior
accuracy designed to detect breast cancer at early stages would have a
substantial impact in the women's health community," said Dr. Andrew von
Eschenbach, former Director of the U.S. National Cancer Institute and former U.S.
Food and Drug Administration Commissioner. Dr. von Eschenbach, a specialist in
urological cancer, is a member of the BioTime and OncoCyte boards of directors.
"Early detection remains our current best hope for achieving cures. Therefore,
the development of more accurate diagnostics and screens for all major cancer
types should be a national priority."

Michael West, Ph.D., CEO of BioTime added, "We are pleased with the deep insights
into cancer biology generated by this discovery effort. These discoveries were
the direct outcome of the broad regenerative medicine and bioinformatics platform
that has been built at the BioTime family of companies and demonstrates the
breadth of potential applications of our technology. Besides leading to novel
diagnostics, these new insights may point the way to future therapeutic
strategies to target and destroy cancer cells while leaving normal tissue
intact."

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused
on regenerative medicine and blood plasma volume expanders. Its broad platform of
stem cell technologies is enhanced through subsidiaries focused on specific
fields of application. BioTime develops and markets research products in the
fields of stem cells and regenerative medicine, including a wide array of
proprietary PureStem(TM) cell lines, HyStem(R) hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia(TM) (formerly known as
HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix
for cell delivery in human clinical applications. BioTime's therapeutic product
development strategy is pursued through subsidiaries that focus on specific organ
systems and related diseases for which there is a high unmet medical need.
BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd. is developing
therapeutic products derived from stem cells for the treatment of retinal and
neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is
developing therapeutic applications of stem cells to treat orthopedic diseases
and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic
and therapeutic applications of stem cell technology in cancer, including the
diagnostic product PanC-Dx(TM) currently being developed for the detection of
cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of
BioTime's proprietary induced pluripotent stem cell technology to reverse the
developmental aging of human cells to treat cardiovascular and blood cell
diseases. BioTime's subsidiary LifeMap Sciences, Inc. markets GeneCards(R), the
leading human gene database, as part of an integrated database suite that also
includes the LifeMap Discovery(TM) database of embryonic development, stem cell
research and regenerative medicine, and MalaCards, the human disease database.
LifeMap Sciences also markets BioTime research products and PanDaTox, an
innovative, recently developed, searchable database that can aid in the discovery
of new antibiotics and biotechnologically beneficial products. BioTime
Acquisition Corporation is a new subsidiary being used to acquire the stem cell
assets of Geron Corporation, including patents and other intellectual property,
biological materials, reagents and equipment for the development of new
therapeutic products for regenerative medicine. BioTime's lead product,
Hextend(R), is a blood plasma volume expander manufactured and distributed in the
U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under
exclusive licensing agreements. Additional information about BioTime can be found
on the web at biotimeinc.com.

About OncoCyte Corporation

OncoCyte Corporation is a majority-owned subsidiary of BioTime, Inc. OncoCyte's
mission is to develop novel products for the diagnosis and treatment of cancer in
order to improve both the quality and length of life of cancer patients.
OncoCyte's molecular diagnostics division is developing products for earlier
detection of a variety of cancers. In addition to its diagnostic product line,
OncoCyte is developing cellular therapies to treat cancer based on the unique
biology of vascular precursor cells. The goal of OncoCyte's therapeutic research
efforts is to derive vascular cells that can be engineered to deliver a toxic
payload to the developing blood vessels of a malignant tumor to destroy the tumor
without killing nearby normal tissues in the body. Additional information on
OncoCyte can be found on the web at oncocyte.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth
in research, technology, clinical development, and potential opportunities for
BioTime and its subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by management
constitute forward-looking statements. Any statements that are not historical
fact (including, but not limited to statements that contain words such as "will,"
"believes," "plans," "anticipates," "expects," "estimates") should also be
considered to be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks inherent in the
development and/or commercialization of potential products, uncertainty in the
results of clinical trials or regulatory approvals, need and ability to obtain
future capital, and maintenance of intellectual property rights. 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 BioTime and its subsidiaries, particularly those
mentioned in the cautionary statements found in BioTime's Securities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update these
forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list:
phx.corporate-ir.net

cts.businesswire.com

SOURCE: BioTime, Inc.

BioTime, Inc.
Peter Garcia, 510-521-3390, ext 367
Chief Financial Officer
pgarcia@biotimemail.com
Judith Segall, 510-521-3390, ext 301
jsegall@biotimemail.com
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