BioTime, Inc. and its subsidiary OncoCyte Corporation today announced that OncoCyte has entered into a License Agreement with Cornell University through which Weill Cornell Medical College will provide blood samples derived from healthy people and lung cancer patients for comparative analysis using the Company’s proprietary PanC-Dx™ diagnostic tests. OncoCyte scientists will determine levels of tumor-associated gene expression in these samples, including assessing levels of its proprietary PanC-Dx™ cancer markers. The results of these analyses, along with the results of the nearly complete clinical study currently being conducted by OncoCyte’s collaborators at The Wistar Institute, will be combined to produce a data set from over 700 patients. This data will be used by OncoCyte to assess the performance of potential cancer markers for the purpose of developing a multi-marker test for the detection of lung cancer. As part of the License, OncoCyte retains all rights to develop and market its proprietary lung cancer diagnostic products.
PanC-Dx™ is a novel class of noninvasive cancer diagnostics that are based on a proprietary set of cancer markers characterized, in part, by broad expression patterns in numerous cancer types. The performance of the marker panel in determining the presence or the progression of disease in various categories of patients will determine the specific nature of the test to be developed and the approval pathway that OncoCyte will pursue.
Annual screening for lung cancer in certain high-risk patients was recently recommended by the United States Preventative 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). Although low-dose CT has demonstrated high sensitivity in detecting early-stage lung cancer in large clinical studies, it also has a high false-positive rate of approximately 25%.
“A blood-based test that accurately discriminates between cancer and benign disease would be of great value. I look forward to working with OncoCyte in helping to develop such a test,” said Nasser Altorki, M.D., the Gerald J. Ford-Wayne Isom Research Professor in Cardiothoracic Surgery and professor of cardiothoracic surgery at Weill Cornell Medical College. Dr. Altorki serves as the “Provider Scientist” on the Agreement, oversaw collection of the patient samples to be tested by OncoCyte, and serves as an informal advisor to OncoCyte in the field of lung cancer diagnostics.
“The recent recommendation by the United States Preventative Services Task Force to annually screen high-risk patients for lung cancer using low-dose CT represents a challenge not only for physicians, but also for insurance coverage providers that now must cover the cost of testing,” said Joseph Wagner, PhD, OncoCyte’s Chief Executive Officer. “Large scale screening of this population, estimated to represent at least three million patients per year, could reduce overall lung cancer mortality through earlier detection. However, the high number of false-positive tests could lead to over a billion dollars a year in unnecessary costs to the United States health care system as a result of associated follow-up testing. Physicians, payers, and patients would therefore welcome a simple to use, low-cost, blood-based test that can help guide patient-management decisions by noninvasively ruling out the presence of cancer. OncoCyte’s licensing agreement with Cornell University, managed by the Cornell Center for Technology, Enterprise and Commercialization, along with our existing collaboration with The Wistar Institute, should help accelerate development of that lung cancer diagnostic product.”