OncoAssure Prostate Test Launches in the US

1 min read

OncoAssure Prostate Test, developed by OncoAssure, an Irish medtech company and an innovator in precision oncology diagnostics, announced the launch of the test in the US market.

Creds: OncoAssure developer of Prostate Test
Creds: OncoAssure developer of Prostate Test

OncoAssure Prostate is a next generation prognostic test designed to support clinical decision-making for men diagnosed with localised prostate cancer.

The novel test helps assess the risk of aggressive disease and disease recurrence and can be used at two key decision points in the prostate cancer pathway, post-biopsy and post-surgery.

Integrating Genomic Insights for Improved Prognosis 

By integrating advanced genomic insights with clinical data, OncoAssure Prostate Test provides a more accurate assessment of disease prognosis, empowering physicians, along with their patients, to make more precise and personalised treatment decisions.

The company made the announcement at the American Urological Association’s (AUA) 2025 Annual Meeting which is taking place in Las Vegas, Nevada.

Addressing Limited Access to Prognostic Testing 

"This launch represents a major milestone in the commercialisation of the test in the US market,” said Des O’Leary, CEO, OncoAssure.

"Access to prognostic testing remains limited for many patients in the US, making the launch of OncoAssure Prostate Test especially timely. This test addresses a critical need by providing reliable information to distinguish between aggressive and low-risk forms of prostate cancer, helping to reduce overtreatment and improve patient outcomes.”

Collaboration and Testing Services 

The OncoAssure Prostate Test is being commercialised in the US in collaboration with DiaCarta Inc. which will provide the testing service from its ISO and CAP/CLIA certified laboratory service, in Pleasanton, California.

Innovation Behind the OncoAssure Process 

The OncoAssure Prostate Test was developed using the innovative OncoAssure Process.

The central principle of the OncoAssure Process is to identify a concise panel of upstream “Master Driver” genes which represent a reliable indicator of disease progression.

The OncoAssure Prostate Test also incorporates the widely used CAPRA (Cancer of the Prostate Risk Assessment) score in the result, allowing seamless integration into current care pathways.

Future Developments and Investment Opportunities 

Des O’Leary emphasising the broader impact of the launch added, "Through the OncoAssure product development process we've successfully delivered our next-generation prognostic test. Building on this momentum, we've made strong progress in developing our next product, a prognostic test for skin melanoma.”

OncoAssure was co-founded by Des O’Leary and Professor William Gallagher in 2021 and is headquartered at NovaUCD in Dublin.
To fund the ongoing commercialisation of OncoAssure Prostate Test, and continued development of novel cancer biomarkers, OncoAssure will be holding an investment round during 2025.