Irish medtech, OncoAssure, is to partner with the prestigious Mount Sinai Icahn School of Medicine in New York to validate the prognostic value of the company’s next generation prostate cancer test. The announcement comes less than a year after the test was launched in the US.

The study will analyse prostate biopsy tissue sampled from men with low- to intermediate-risk prostate cancer to determine the added prognostic value of the OncoAssure Prostate Test beyond routinely used clinical and pathological information.

The study will be led by Professor Ash Tewari, Professor and Chair of the Department of Urology at the Icahn School of Medicine. 

Commenting on the new collaboration, Professor Tewari said: “At Mount Sinai, we place a strong emphasis on carefully evaluating emerging diagnostic technologies before they are incorporated into routine care. Our collaboration with OncoAssure is focused on rigorous clinical evaluation of the OncoAssure Prostate Cancer Test to better understand its potential role in patient management and how it could provide meaningful benefit to our patients.

“Through this collaborative agreement, we aim to generate high-quality evidence on how precision diagnostics may best support clinicians in personalising treatment decisions, including efforts to reduce overtreatment and, where possible, more reliably identify aggressive cancers.”

Build on studies

Des O’Leary, CEO of OncoAssure, added: “By applying our innovative OncoAssure Prostate technology in collaboration with the Icahn School of Medicine, we aim to generate additional evidence supporting the potential of the OncoAssure Prostate Cancer Test to both reduce unnecessary interventions and provide critical lead time for treating the most aggressive tumours. This work will build on prior studies conducted in collaboration with Lund University in Sweden.”

OncoAssure Prostate Test is a next generation prognostic test designed to support clinical decision-making for men diagnosed with localised prostate cancer. It can be used post-biopsy and post-surgery to assess the risk of aggressive disease and disease recurrence.

The test uses a novel process that identifies ‘master driver’ genes in biopsy samples. These genes are strong indicators of disease progression. The test also incorporates Cancer of the Prostate Risk Assessment (CAPRA) scores, allowing integration into current care pathways.

By integrating advanced genomic insights with clinical data, OncoAssure Prostate provides a more accurate assessment of disease prognosis, allowing more precise and personalised treatment decisions.

US launch

The test was launched in the US market at the annual American Urology Association (AUA) meeting last April, and is currently available in the US as a CLIA Certified Lab Service.

OncoAssure was co-founded by Des O’Leary and Professor William Gallagher in 2021, and is headquartered at NovaUCD in Dublin.