Full Press Release Details
Wistar Institute and BioTime Subsidiary OncoCyte Corporation Expand
Agreement to Develop Molecular Diagnostic Test for the Detection of Lung
provides for continued development of a liquid biopsy test designed to
aid physicians in the early, non-invasive detection of lung cancer
PHILADELPHIA & ALAMEDA, Calif.--(BUSINESS WIRE)--August 18, 2015--The
Wistar Institute and BioTime, Inc. (NYSE MKT: BTX) announced that Wistar
and BioTime's subsidiary OncoCyte Corporation, have expanded their
collaborative relationship to develop a simple, non-invasive,
blood-based test designed to aid physicians in the early detection of
lung cancer. This expanded collaboration follows earlier clinical
trials, the interim results of which were presented at the May 2015
American Thoracic Society (ATS) International Conference. Wistar is an
international biomedical research leader in cancer, immunology and
infectious diseases. OncoCyte is a developer of novel, non-invasive
liquid biopsy products for the early detection of cancer.
In October 2013, OncoCyte entered into a Sponsored Research Agreement
with The Wistar Institute, a National Cancer Institute-designated cancer
center, to develop and test potential lung cancer biomarkers identified
by Dr. Louise Showe, Ph.D., professor in Wistar's Molecular and Cellular
Oncogenesis Program. Under the new expanded agreement, OncoCyte and
Wistar will continue their collaboration with the goal of developing a
highly sensitive and specific diagnostic test for the early detection of
lung cancer. Critical to the success of the next phase of the research
and development program will be the analysis of an expanded patient
sample set, the transition of sample analysis to a platform capable of
commercial scale operations, confirmation of mRNA and miRNA expression,
and completion of diagnostic test verification activities.
"I look forward to continuing this productive relationship between my
lab at Wistar and our collaborators at OncoCyte," said Dr. Showe,
professor, Wistar's Molecular and Cellular Oncogenesis Program;
associate director, Center for Systems and Computational Biology;
scientific director, Genomics Facility; and scientific director,
Bioinformatics Facility. "Lung cancer takes a terrible toll on life and
productivity every year. We hope we can impact that toll in some
meaningful way, through the ongoing studies."
"We look forward to building on the initial success of our partnership
with The Wistar Institute, and are excited about our progress to date,"
said William Annett, Chief Executive Officer of OncoCyte. "As we
continue to develop our liquid biopsy for the early detection of lung
cancer, we are enthusiastic about the opportunity to have a major impact
on the lives of those that suffer from lung cancer."
Interim Results from Initial Agreement
In May 2015, OncoCyte and The Wistar Institute announced the interim
results of a large, clinical study conducted by Dr. Showe and funded by
OncoCyte. The clinical interim results from a blood-based diagnostic
test for non-invasive detection of lung cancer were presented at the
American Thoracic Society (ATS) International Conference. These results
from the assayed samples demonstrated a high level of observed
sensitivity and specificity of a simple blood-based test designed to aid
physicians in the early detection of lung cancer. Performance of the
classifier was evaluated using several criteria, including Receiver
Operating Characteristic (ROC) area under the curve (AUC) analysis, and
yielded an AUC of 0.88 (sensitivity of 76% with a specificity of 88%) in
Dependent on achieving successful scientific and technical results at
this stage of development, OncoCyte and Wistar will proceed to final
validation of the test with the goal of completing that work in 2016 to
enable OncoCyte to commercially launch the lung diagnostic test.
OncoCyte has exercised options to obtain exclusive licenses to any
inventions, discoveries or technology developed in the course of the
collaborative research and expects to finalize definitive license
agreements with Wistar in the near future.
Lung cancer remains a primary cause of cancer-related death in part
because there is no effective diagnostic test to screen patients for
lung cancer at an early stage. Annual screening for lung cancer in
certain high-risk patients was recently recommended by the United States
Preventive 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) scans. Although low-dose CT scans have demonstrated high
sensitivity in detecting early-stage lung cancer in large clinical
studies, it also has a relatively high false-positive rate of
approximately 25%. False positives can lead to unnecessary costs and
side effects due to the need for highly-invasive diagnostic procedures
such as bronchoscopies and lung biopsies.
Large-scale screening of patients at high risk for lung cancer, an
estimated seven to ten million patients per year in the U.S., could
reduce overall lung cancer mortality through earlier detection. However,
the high number of false-positive low-dose CT tests could lead to
significant unnecessary costs to the U.S. health care system as a result
of associated follow-up testing. Physicians, payers, and patients may
therefore welcome a simple to use, low-cost, blood-based test that can
help guide patient-management decisions by noninvasively ruling out the
About OncoCyte Corporation
OncoCyte is focused on the development of novel, non-invasive liquid
biopsy products for the early detection of cancer.
The company believes that early detection of cancer will improve the
quality and length of life of cancer patients. While current diagnostic
tests use invasive surgical procedures to provide tissue samples in
order to determine if a tumor is benign or malignant, next generation
diagnostic tests will be liquid biopsies using blood or urine samples.
Based on their large market sizes and high unmet medical needs, OncoCyte
is initially focusing its efforts on developing liquid biopsy products
for detecting lung, bladder and breast cancer. Clinical studies are
underway in all three products. OncoCyte's products are based on a
proprietary set of cancer markers characterized, in part, by broad gene
expression patterns in numerous cancer types.
OncoCyte is a partially owned subsidiary of BioTime, Inc., a pioneer in
regenerative medicine and a clinical-stage biotechnology company.
BioTime and its subsidiaries are leveraging their industry-leading