OncoCyte Corporation, a subsidiary of BioTime, Inc., and Abcodia Ltd. have announced their collaboration focused on the development of OncoCyte’s blood-based PanC-Dx™ test for early detection of breast cancer.
PanC-Dx™ 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.
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 early detection of cancer and its precursors is associated with improved outcomes for patients. Mammography has been widely used since the 1970s for breast cancer screening in asymptomatic women; in 2010 over 30 million screening mammograms were performed in the US alone. Current US National Cancer Institute (NCI) guidelines recommend screening mammograms every 1 to 2 years in women 40 years and older, while the American Cancer Society and the National Comprehensive Cancer Network both recommend screening mammography every year starting at age 40. This screening in women aged 40 to 74 has been associated with relative reduction in breast cancer mortality of 15% to 20%. However, the NCI estimates that approximately 20% of all breast cancers are not detected by mammography during annual screening which indicates there is an unmet need for a breast-cancer screening test with superior specificity and sensitivity when compared to standard screening mammography. PanC-Dx™ does not involve radiation exposure and could be indicated for all women regardless of age, and could be performed during the course of regular care with a familiar physician at low cost.
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.
“A high-performing, blood-based breast cancer screening test would have multiple potential uses and users. Ultimately, our breast-cancer test could be used in conjunction with all screening mammography in order to detect breast cancer early and with a high degree of certainty. Working with Abcodia and using their unique set of longitudinal pre-diagnosis breast cancer samples will be of great value in generating robust validation data to support broader user adoption of our breast cancer diagnostic. We look forward to collaborating with them on this important product,” said Joseph Wagner, PhD, OncoCyte’s Chief Executive Officer.
“We are pleased to partner with OncoCyte to help assess the utility of PanC-Dx™ for the early detection of breast cancer,” said Julie Barnes, Abcodia's CEO. “A simple blood test to complement mammography could help to significantly improve early diagnosis and therefore treatment outcomes. Working additionally with our University College London colleagues, we aim to support OncoCyte’s mission by designing a useful series of cohort studies that will optimize the market positioning of OncoCyte’s interesting technology.”