Date: 2014-09-15
Type of information: Development agreement
Compound: PanC-Dx™
Company: OncoCyte Corporation, BioTime, Inc.\'s Subsidiary (USA - CA) Abcodia (UK)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: development
Action mechanism: PanC-DxT™ is a class of non-invasive cancer diagnostics based on OncoCyte\'s proprietary set of cancer markers, which were discovered by company scientists through an analysis of broad gene expression patterns in numerous cancer types. OncoCyte is currently sponsoring four clinical studies of PanC-Dx™ in bladder, breast, and lung cancer.
Disease: breast cancer
Details: * On September 15, 2014, OncoCyte Corporation , a subsidiary of BioTime, Inc, and Abcodia , a UK -based company focusing on the early detection of cancer, announced their collaboration focused on the development of OncoCyte\'s blood-based PanC-Dx™ test for early detection of breast cancer. Abcodia has exclusive commercial access to a unique longitudinal biobank of over 5,000,000 serum samples collected through the UK Collaborative Trial for Ovarian Cancer Screening. The biobank was derived from over 200,000 initially healthy volunteers, 50,000 of whom provided samples annually for up to 10 years. Since first recruitment, more than 3,700 individuals have been diagnosed with breast cancer, which generates opportunities to assess serum biomarker changes that occurred years before the diagnosis of breast cancer was made. The collaboration will begin with an initial study to be completed by the end of 2014. Under the terms of the current agreement, OncoCyte will test the performance of its proprietary PanC-Dx™ cancer markers in detecting breast cancer in a set of patient samples selected from the biobank by Abcodia. If the outcome of this initial study is promising, future studies could proceed and expand into the use of a larger cohort to assess OncoCyte\'s PanC-Dx™ cancer markers in a case-controlled longitudinal design. Because of the very large number of samples in the biobank, it may be possible to execute a very large study of PanC-Dx™ much more quickly than otherwise would be possible, potentially accelerating the broad commercialization of the test. The performance of the test in detecting the absence, presence, and development of early breast cancer will be considered in determining the intended use for PanC-Dx™ and the regulatory approval pathway that OncoCyte will pursue. As part of the initial collaboration, OncoCyte retains all rights to develop and market its proprietary breast cancer diagnostic products.
The collaboration with Abcodia represents an expansion of OncoCyte\'s breast cancer clinical development program, which began early in 2014 with the initiation of an OncoCyte-sponsored 600-patient study at Scottsdale Medical Imaging Laboratories (SMIL) in Scottsdale, Arizona . Data from both studies will be used to support an initial use of the breast cancer diagnostic test by radiologists to aid in determining the malignancy potential of suspicious mammography findings, and by oncologists as a tool for recurrence surveillance in breast-cancer survivors. OncoCyte expects analysis of data from the SMIL cohort should be also completed by the end of 2014.
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