DiaCarta partners with OncoAssure for prostate cancer test commercialization

DiaCarta, Inc. ("DiaCarta"), a pioneer in molecular diagnostic test development for cancer and infectious diseases, based in California, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company headquartered at NovaUCD in Dublin.

The focus of the collaboration is to commercialize OncoAssure's groundbreaking prostate test which is designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring post-treatment.

OncoAssure's prostate prognostic test is a 6-gene expression assay that assesses the risk of aggressive disease post-diagnosis and the risk of biochemical recurrence over a 5-year period post-surgery.

The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure prostate test. The collaboration also includes the application to the Centers for Medicare & Medicaid Services (CMS) for coding, billing, and reimbursement.

We are delighted to collaborate with DiaCarta. DiaCarta has established a high-quality CAP/CLIA laboratory for LDT testing in California. This partnership will expedite the validation process and pave the way for commercialization of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike."

Des O'Leary, CEO of OncoAssure

Dr Adam (Aiguo) Zhang, CEO and President of DiaCarta, added, "We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialization in DiaCarta's CAP/CLIA laboratory. The OncoAssure team has a proven track record for developing high quality prognostic tests including the OncoMasTR breast cancer prognostic test acquired by Cepheid in 2021. The unique OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and is a valued addition to DiaCarta's portfolio of molecular diagnostic tests for cancer that includes tests for bladder and colorectal cancer."