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DiaCarta, OncoAssure Collaborate on Prostate Cancer LDT Launch

NEW YORK – DiaCarta and OncoAssure said Monday that the firms had formed a strategic collaboration to commercialize in the US OncoAssure's test used to stratify prostate cancer patients by their risk of cancer recurrence and to guide decisions on patient surveillance and posttreatment monitoring.

The OncoAssure Prostate six-gene expression RT-qPCR assay is a prognostic test that is used to identify the risk of aggressive disease following diagnosis and the risk of recurrence in the five years following surgery. Pleasanton, California-based DiaCarta will provide its clinical diagnostic services expertise to complete validation of the Prostate test as a laboratory-developed test (LDT). The firms said that the collaboration will include submission of an application to the US Centers for Medicare and Medicaid Services (CMS) for coding, billing, and reimbursement.

Financial and other terms of the deal were not disclosed.

Des O'Leary, CEO of Dublin, Ireland-based OncoAssure, said in a statement that DiaCarta's College of American Pathologists-accredited and CLIA-certified laboratory facilities in California will be used for the LDT testing.

"This partnership will expedite the validation process and pave the way for commercialization of the OncoAssure Prostate LDT," O'Leary said.

DiaCarta CEO Aiguo Zhang added that the OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and has become a valuable addition to DiaCarta's portfolio of molecular diagnostic tests along with other tests for bladder and colorectal cancer.