ALAMEDA, Calif.—BioTime, Inc. and OncoCyte Corp., its subsidiary, have announced the establishment of a license agreement between OncoCyte and Cornell University aimed at developing a diagnostic test for lung cancer. Under the agreement, Weill Cornell Medical College will provide blood samples from healthy individuals and lung cancer patients for comparative analysis using OncoCyte’s proprietary PanC-Dx diagnostic test. No financial details were disclosed.
OncoCyte’s scientists will determine the levels of tumor-associated gene expression in the samples, as well as levels of its proprietary PanC-Dx cancer markers, with the results to be combined with those from the clinical trial being conducted by OncoCyte collaborators at The Wistar Institute. OncoCyte will use the data set, compiled from more than 700 patients, to evaluate the performance of potential cancer markers for use in developing a multi-marker test to detect lung cancer. The company will retain all rights to develop and market its proprietary lung cancer diagnostic products.
“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,” commented Dr. Nasser Altorki, the Gerald J. Ford-Wayne Isom Research Professor in Cardiothoracic Surgery and professor of cardiothoracic surgery at Weill Cornell Medical College. Altorki oversaw the collection of patient samples and serves as an informal advisor to OncoCyte in the field of lung cancer diagnostics.
OncoCyte’s PanC-Dx is a novel class of noninvasive cancer diagnostics based on a proprietary set of cancer markers, which are characterized, in part, by broad expression patterns in several cancer types. The panel’s performance in identifying the presence or progression of disease in different sets of patients will determine the nature of the test the company will develop and the approval pathway to be pursued.
The United States Preventative Services Task Force (USPSTF), an independent panel of experts in primary care and prevention, recently recommended that high-risk patients undergo annual screening for lung cancer. Specifically, the USPSTF recommended screening that utilizes low-dose computed tomography, though that approach has some drawbacks: despite its proven ability to have high sensitivity in detecting early-stage lung cancer in large clinical trials, it also has a false-positive rate of roughly 25 percent.
“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,” Dr. Joseph Wagner, CEO of OncoCyte, said in a press release. “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 non-invasively 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.”
SOURCE: OncoCyte press release