Date: 2015-08-18
Type of information: Development agreement
Compound: blood-based test for the early detection of lung cancer
Company: OncoCyte Corporation, BioTime, Inc.\'s Subsidiary (USA - CA) The Wistar Institute (USA - PA)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: collaboration development
Action mechanism:
Disease: lung cancer
Details: * On August 18, 2015, the Wistar Institute and BioTime 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. 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 the test set. 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. 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.
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