Diagnostic companies DiaCarta and OncoAssure have announced a collaboration to launch a lab-developed test for prostate cancer.
The collaboration aims to commercialise OncoAssure’s prostate cancer test, which is designed to help identify patients with a lower risk of recurrence post-treatment.
This prognostic test is a six-gene expression assay that evaluates the risk of aggressive prostate cancer and the likelihood of biochemical recurrence within five years after surgery.
The partnership will utilise DiaCarta’s expertise in clinical diagnostic services to complete the laboratory-developed test (LDT) validation for the OncoAssure Prostate test.
OncoAssure CEO Des O’Leary said: “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 commercialisation of the OncoAssure Prostate LDT test, benefitting healthcare providers and patients alike.”
Furthermore, the collaboration extends to seeking approvals from the CMS for coding, billing and reimbursement processes.
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DiaCarta CEO and president Dr Adam (Aiguo) Zhang said: “We are very pleased to collaborate with OncoAssure to bring the best-in-class, highly accurate OncoAssure Prostate LDT test to commercialisation 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.”
Last year, AnchorDx and DiaCarta collaborated on the development of new cancer screening tests.
The partnership agreed to utilise technologies for DNA methylation and mutation detection developed by each company.
