OncoAssure Announces Collaboration with Leading US Medical Centre for Prostate Cancer Test Validation Study

(opens in a new window)OncoAssure, an Irish medtech company and a leading innovator in precision oncology diagnostics, today announced the signing of a research collaboration agreement with the (opens in a new window)Icahn School of Medicine at Mount Sinai, in New York, which will facilitate the performance of a new validation study utilising OncoAssure’s Prostate Cancer Test and curated clinical samples from Icahn School of Medicine at Mount Sinai.

The Icahn School of Medicine at Mount Sinai is an international leader in biomedical education, research, and patient care and is the medical school for the Mount Sinai Health System in New York, which includes seven hospital campuses.

The OncoAssure Prostate Test 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.

The new study will be led by Ash Tewari, MD, a physician-scientist and world-renowned urologist and prostate cancer specialist, in collaboration with basic and translational cancer researchers, Sujit S. Nair, PhD, and Dimple Chakravarty, PhD.

They will analyse prostate biopsy tissue from men with low- to intermediate-risk prostate cancer (as defined by the US National Comprehensive Cancer Network guidelines), with the primary objective of assessing the prognostic value of the OncoAssure Prostate Test in a representative cohort. The study will also evaluate the added prognostic value of the OncoAssure Prostate Test beyond routinely used clinical and pathological information.

“OncoAssure is proud to announce a strategic collaborative research agreement with the Icahn School of Medicine at Mount Sinai, one of the top medical centres in the United States,” said, Des O’Leary, CEO, OncoAssure Ltd.

“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 tumors. This work will build on prior studies conducted in collaboration with Lund University in Sweden.”

Professor Ash Tewari, Professor and System Chair of the Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mount Sinai, Surgeon-in-Chief of the Tisch Cancer Hospital, and Director of the Center of Excellence for Prostate Cancer, the Lizzie and Jonathan Tisch Center for Prostate Health, and the Robert F. Smith Prostate Cancer Disparity Program, 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.”

The OncoAssure Prostate Test was developed using a novel process that identifies ‘Master Driver’ genes that are strong indicators of disease progression. The test also incorporates the widely used CAPRA (Cancer of the Prostate Risk Assessment) score in the result, allowing seamless integration into current care pathways.

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

The OncoAssure Prostate Cancer Test was launched in the US market at the annual American Urology Association (AUA) meeting last April. The Test is available as a CLIA Certified Lab Service (for details see (opens in a new window)www.oncoassure.com).

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

Note: Des O’Leary, CEO, OncoAssure is available for further comment and interview and can be contacted via e: (opens in a new window)des.oleary@oncoassure.com.

ENDS

7 January 2026

For further information contact Micéal Whelan, Communications and Media Relations Manager, UCD Research and Innovation, NovaUCD, e: (opens in a new window)miceal.whelan@ucd.ie or Des O’Leary, OncoAssure, e: (opens in a new window)des.oleary@oncoassure.com.

Editors Notes

OncoAssure is a precision diagnostics company committed to transforming cancer care through the development of cutting-edge genomic tools. Our mission is to deliver clinically meaningful insights that improve patient outcomes and support more informed treatment decisions across the oncology spectrum.  (opens in a new window)https://www.oncoassure.com/

With over 7,000 faculty, 1,200 students, and 2,500 residents and fellows, the Icahn School of Medicine at Mount Sinai are propelled by cutting-edge technology, breakthrough research, and multidisciplinary teamwork. Our advances arise from a willingness to challenge conventional wisdom, and together we make big, bold bets, producing dramatically better outcomes for our patients. (opens in a new window)https://icahn.mssm.edu/