BioTime, Inc.,a biotechnology company engaged in research and product development in the field of regenerative medicine, has announced that its subsidiary OncoCyte Corporation have entered into a sponsored research agreement and a material transfer agreement with The Wistar Institute to collaboratively develop lung cancer diagnostic products. As part of the collaboration, Wistar investigators are conducting a multi-centre patient study in which they are assessing gene expression patterns in blood cells of patients with malignant versus non-malignant lung disease.

OncoCyte scientists will analyze blood samples obtained from patients in the study to determine levels of tumor-associated proteins using its proprietary PanC-Dx diagnostic tests. 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 inclusion of the PanC-Dx markers in Wistar's ongoing multi-centre study may allow OncoCyte to more rapidly develop a diagnostic test for lung cancer to be marketed in the US and other countries. The performance of markers tested in the study in determining the presence or the progression of disease in various categories of patients may determine the specific nature of the lung cancer test to be developed and the regulatory approval pathway that OncoCyte will pursue. OncoCyte will have an option to exclusively license any inventions, discoveries or technology developed by Wistar, or by OncoCyte using Wistar technology, in the course of the collaborative research.

Wistar investigators, led by Louise Showe, Ph.D., have previously demonstrated the feasibility of detecting early stage lung cancer by taking a snapshot of gene activity in circulating blood cells. 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. The current study is being conducted on patients recruited through grant partners at multiple clinical sites. Thus far over 400 patient samples out of a planned total of 600 have been obtained. Completion of the study, which began mid-2012, is expected in mid-2014.

"I look forward to collaborating with the OncoCyte team to validate blood-based molecular markers for the diagnosis of cancer," said Dr Showe, a professor in the Molecular and Cellular Oncogenesis program of Wistar's NCI-designated Cancer Centre. "There is a large and growing need for more sensitive, cost-effective, and less invasive methods to detect and monitor cancer in humans, particularly in lung cancer. In addition to the development of a diagnostic gene panel, our previous studies provided new insights into the interactions of cancer and the immune system. We look forward to expanding those studies through this collaboration."

"We are impressed by the quality of the genomics and bioinformatics capabilities at The Wistar Institute. These capabilities, combined with Wistar's ongoing access to patient samples, are expected to accelerate the development of a blood-based lung cancer diagnostic and strategically fits into our overall PanC-Dx development strategy," said Joseph Wagner, PhD, OncoCyte's chief executive officer.

OncoCyte has previously published in peer-reviewed scientific journals data relating to two PanC-Dx markers: COL10A1, a marker associated with the vasculature of numerous solid tumors, and FSIP1, a marker unique to breast cancer.

"We believe the formula for leadership in the emerging field of regenerative medicine is to have a balanced product development strategy that includes both products like PanC-Dx that may be developed and commercialized in the near term, and therapeutic products derived from pluripotent stem cell technology that will require a longer path to commercialization but that have the potential to successfully treat large patient populations with high unmet medical needs. OncoCyte's diagnostic patient study collaboration with the Wistar Institute is one component of that strategy, as is the recent entry in to human clinicals of Renevia, and the development of pluripotent stem cell therapies at some of our subsidiaries, including Asterias Biotherapeutics, Inc. and Cell Cure Neurosciences Ltd.," said Dr Michael West, BioTime's chief executive officer.

The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development.