BioTime’s Subsidiary OncoCyte Corporation Provides an Update on the Development of the Novel Pan-Cancer Diagnostic …

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE MKT: BTX) and BioTimes subsidiary OncoCyte Corporation provided an update on the progress of development of PanC-DxTM, 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-DxTM 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-DxTM 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-DxTM development throughout 2013.

OncoCytes 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-DxTM 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:

Key goals for 2013 will be:

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-DxTM as an in vitro diagnostic (IVD) in Europe, potentially commencing in 2014, before seeking FDA approval required to market PanC-DxTM in the United States. Some CLIA-certified clinical laboratories may choose to offer PanC-DxTM on a limited basis prior to EU and FDA approval.

OncoCyte has made substantial progress in the development of PanC-DxTM 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 womens 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.

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BioTime’s Subsidiary OncoCyte Corporation Provides an Update on the Development of the Novel Pan-Cancer Diagnostic ...