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OncoCyte, Abcodia Collaborate on Breast Cancer Dx

NEW YORK (GenomeWeb) – OncoCyte and Abcodia today announced they will collaborate on the development of OncoCyte's gene expression-based diagnostic test for the early detection of breast cancer.

Under the terms of the deal, OncoCyte will test the performance of its proprietary PanC-Dx cancer biomarkers for detecting breast cancer in a set of patient samples selected by Abcodia, which has exclusive commercial access to a biobank of more than 5 million serum samples collected through the UK Collaborative Trial for Ovarian Cancer Screening. The biobank was derived from more than 200,000 initially healthy volunteers, 50,000 of whom provided samples each year for up to a decade. More than 3,700 of the volunteers have also been diagnosed with breast cancer since the first recruitment.

Based on the success of the initial study, additional studies may be conducted and expanded into a larger cohort to evaluate PanC-Dx cancer markers in a case-controlled longitudinal design, the partners said. The performance of PanC-Dx in detecting the absence, presence, and development of breast cancer will be used to determine the intended use for the blood-based assay and the regulatory approval pathway that OncoCyte may pursue.

OncoCyte has retained all rights to develop and market its proprietary breast cancer diagnostic products. It has previously said that it plans to launch PanC-Dx in Europe as an in vitro diagnostic and to seek approval from the US Food and Drug Administration for the test. A spokesperson said that OncoCyte does not have a CLIA-certified laboratory but may pursue certification in early 2015 based on results from ongoing clinical trials for three products.

OncoCyte's PanC-Dx tests are based on a set of markers discovered by the company's researchers through an analysis of broad gene expression patterns in numerous cancer types. The firm, which is a subsidiary of BioTime, is currently sponsoring four clinical studies of the technology for bladder, breast, and lung cancer.

Today's deal, the partners said, expands on OncoCyte's breast cancer clinical development program, started earlier this year with a 600-patient study at Scottsdale Medical Imaging Laboratories in Arizona. Analysis of the data is anticipated to be completed by the end of the year.

Data from that study, as well as the study being conducted with Abcodia, will be used to support an initial use of PanC-Dx for breast cancer by radiologists to help determine the malignancy potential of suspicious mammography results, and by oncologists as a tool for recurrence surveillance in survivors of breast cancer, the companies said.

"Ultimately, our breast cancer test could be used in conjunction with all screening mammography in order to detect breast cancer early and with a large degree of certainty," OncoCyte CEO Joseph Wagner said in a statement. "Working with Abcodia and using [its] 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."

Financial and other terms of the agreement were not disclosed.

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